Compositions for treating gastrointestinal side effects of weight loss and diabetes medications

Abstract

The present invention discloses a method for alleviating gastrointestinal side effects resulting from the administration of pharmaceutical agents selected from the group including non-steroidal anti-inflammatory drugs (NSAIDs), glucagon-like peptide-1 (GLP-1) receptor agonists, gastric inhibitory polypeptide (GIP) receptor agonists, dual GIP / GLP-1 receptor co-agonists, and combinations thereof, by administering a composition containing colostrum product, bovine colostrum, or combinations thereof to a subject. The present invention discloses compositions and kits related to alleviating gastrointestinal side effects resulting from the administration of pharmaceutical agents selected from a group including non-steroidal anti-inflammatory drugs (NSAIDs), glucagon-like peptide-1 (GLP -1) receptor agonists, gastric inhibitory polypeptide (GIP) receptor agonists, dual GIP / GLP -1 receptor co-agonists, and combinations thereof. This method provides a novel approach to mitigate gastrointestinal side effects associated with the use of these pharmaceutical agents, enhancing patient comfort and compliance during treatment.

Description

Attorney Docket No.: 148548-001102COMPOSITIONS FOR TREATING GASTROINTESTINAL SIDE EFFECTS OF WEIGHT LOSS AND DIABETES MEDICATIONSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims priority to U.S. Provisional Application No. 63 / 700,435 filed on September 27, 2024, which is incorporated herein by reference.BACKGROUND OF THE INVENTION

[0002] Obesity and diabetes are significant global health concerns that affect millions of people worldwide. These conditions are often interrelated, with obesity being a major risk factor for developing type 2 diabetes. As the prevalence of these conditions continues to rise, there is an increasing need for effective treatments and management strategies.

[0003] In recent years, a class of medications known as glucagon-like peptide- 1 (GLP-1) receptor agonists has emerged as a promising treatment option for both weight loss and diabetes management. These medications work by mimicking the effects of the naturally occurring hormone GLP-1, which plays a crucial role in regulating blood sugar levels and appetite. Similarly, gastric inhibitory polypeptide (GIP) receptor agonists have emerged as another class of medications with potential benefits for metabolic disorders. GIP is an incretin hormone that stimulates insulin secretion in response to nutrient intake. GIP receptor agonists may enhance glucose-dependent insulin secretion, reduce glucagon levels, and potentially influence appetite and food intake. Some studies suggest that GIP receptor agonists may have complementary effects to GLP-1 receptor agonists, leading to the development of dual GIP / GLP-1 receptor co-agonists. These dual-action medications aim to harness the beneficial effects of both GIP and GLP-1 signaling pathways, potentially offering enhanced glycemic control and weight loss outcomes compared to single-receptor agonists. However, like GLP-1 receptor agonists, GIP receptor agonists and dual agonists may also be associated with gastrointestinal side effects, highlighting the need for strategies to mitigate these adverse events and improve patient tolerability.

[0004] Though acting on different pathways and used for distinct disorders, use of non-steroidal anti-inflammatory drugs (NSAIDs) is often limited by gastrointestinal complications which are, at times, severe. NSAIDs are widely used for conditions such as osteoarthritis, rheumatoid arthritis, gout, and postoperative pain. Aspirin, for example, inhibits cyclogenoxidase-1 (COX-1) and cyclogenoxidase-2 (COX-2) and is commonly used for its antiplatelet effects in cardiovascular disease prevention. Despite their efficacy, NSAIDs such as aspirin are associated with a range of adverse effects, including gastrointestinal bleeding, cardiovascular events, and renal impairment. These risks are particularly pronounced in olderAttorney Docket No.: 148548-001102 adults and those with comorbid conditions. NSAID research focuses on improving safety profiles and enhancing drug delivery systems. The global NSAID market continues to grow, driven by the rising prevalence of chronic pain and arthritis, especially among aging populations. However, the potential for serious adverse events underscores the importance of individualized treatment strategies and ongoing advancements to optimize therapeutic outcomes.

[0005] These gastrointestinal side effects can be significant barriers to patient adherence and may lead to discontinuation of therapy in some cases. Managing these side effects is crucial for ensuring patient compliance and maximizing the therapeutic benefits of both NSAIDs and GLP-1 receptor agonists.

[0006] Current approaches to managing gastrointestinal side effects of NSAIDs and GLP-1 receptor agonists typically involve dose titration, dietary modifications, and in some cases, the use of additional medications to alleviate symptoms. However, these strategies may not be sufficient for all patients, and there remains a need for more effective and well-tolerated approaches to mitigate these side effects.

[0007] As the use of NSAIDs, GLP-1 receptor agonists and other medications with negative gastrointestinal effects continue to expand for pain relief, weight loss and diabetes management, there is growing interest in developing complementary therapies or interventions that can help alleviate the associated gastrointestinal side effects. Such approaches could potentially improve patient tolerance, adherence, and overall treatment outcomes.SUMMARY OF THE INVENTION

[0008] In some aspects, the techniques described herein relate to a method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition, wherein the composition includes an effective amount of a colostrum product and an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0009] In some aspects, the techniques described herein relate to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP- 1 receptor co-agonist, and combinations thereof; and a properly titrated composition including a colostrum product and an egg product.Attorney Docket No.: 148548-001102In some aspects, the techniques described herein relate to a composition including an effective amount of a colostrum product and an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 depicts complementary modes of action for egg and bovine colostrum.

[0011] FIG. 2 depicts the effect of egg plus bovine colostrum on gut health.

[0012] FIG. 3 shows the efficacy of egg + BC in alleviating GLP-1 -induced GI sideeffects in 20 symptomatic subjects.

[0013] FIG. 4 shows the efficacy of egg + BC in alleviating GLP-1 -induced GI sideeffects in 30 symptomatic subjects.

[0014] FIG. 5 shows the frequency of GI side effects in GLP-1 -treated patients and the overall benefit of egg and BC.DETAILED DESCRIPTION OF THE INVENTION

[0015] Various aspects will be described in detail hereinafter. Such aspects may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art.

[0016] The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.Attorney Docket No.: 148548-001102

[0017] Where a range of values is provided, it is intended that each intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure. For example, if a range of 1 wt % to 8 wt % is stated, it is intended that 2 wt %, 3 wt %, 4 wt %, 5 wt %, 6 wt %, and 7 wt % are also explicitly disclosed, as well as the range of values greater than or equal to 1 wt % and the range of values less than or equal to 8 wt %.

[0018] All percentages, parts and ratios are based upon the total weight of the formulations and compositions and all measurements made are at about 25 °C, unless otherwise specified.

[0019] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a “polymer” includes a single polymer as well as two or more of the same or different polymers; reference to an “excipient” includes a single excipient as well as two or more of the same or different excipients, and the like.

[0020] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0021] The word “about” when immediately preceding a numerical value means a range of plus or minus 10% of that value, e.g, “about 50” means 45 to 55, “about 25,000” means 22,500 to 27,500, etc, unless the context of the disclosure indicates otherwise, or is inconsistent with such an interpretation. For example, in a list of numerical values such as “about 49, about 50, about 55, “about 50” means a range extending to less than half the interval(s) between the preceding and subsequent values, e.g, more than 49.5 to less than 52.5. Furthermore, the phrases “less than about” a value or “greater than about” a value should be understood in view of the definition of the term “about” provided herein.

[0022] The terms “administer,” “administering” and “administration” as used herein refer to either directly administering a compound (also referred to as an agent of interest) or pharmaceutically acceptable salt of the compound (agent of interest) or a composition to a subject.

[0023] The term "combination therapy" means the administration of two or more therapeutic agents to treat a medical condition or disorder described in the present disclosure. Such administration encompasses co-administration of these therapeutic agents in a substantially simultaneous manner, such as in a single capsule, or dosage presentation, having a fixed ratio of active ingredients or in multiple, separate capsules for each active ingredient. In addition, such administration also encompasses use of each type of therapeutic agent in a sequential manner in the same patient, with delivery of the individual therapeutics separated by 1-24 hours, 1-7 days,Attorney Docket No.: 148548-001102 or 1 or more weeks. In either case, the treatment regimen will provide beneficial effects of the drug combination in treating the conditions or disorders described herein.

[0024] The transitional term “comprising,” which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. By contrast, the transitional phrase “consisting of’ excludes any element, step, or ingredient not specified in the claim. The transitional phrase “consisting essentially of’ limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed subject matter. In some embodiments or claims where the term comprising is used as the transition phrase, such embodiments can also be envisioned with replacement of the term “comprising” with the terms “consisting of’ or “consisting essentially of.”

[0025] The term “composition” as used herein refers to a combination or a mixture of two or more different ingredients, components, or substances.

[0026] As used herein, the term “effective amount” refers to an amount that results in measurable inhibition of at least one symptom or parameter of a specific disorder or pathological process. As used herein, the term “therapeutically effective amount” of compositions of the application is an amount which confers a therapeutic effect on the treated subject, at a reasonable benefit / risk ratio applicable to any medical treatment. The therapeutic effect may be objective (that is, measurable by some test or marker) or subjective (that is, the subject gives an indication of or feels an effect, or a physician observes a change).

[0027] The phrase “pharmaceutically acceptable” or “cosmetically acceptable” is employed herein to refer to those agents of interest / compounds, salts, compositions, dosage forms, etc, which are within the scope of sound medical judgment suitable for use in contact with the tissues of human beings and / or other mammals without excessive toxicity, irritation, allergic response, or other problem or complication, commensurate with a reasonable benefit / risk ratio. In some aspects, pharmaceutically acceptable means approved by a regulatory agency of the federal or a state government, or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in mammals (e.g, animals), and more particularly, in humans.

[0028] The terms “patient” and “subject” are interchangeable and may be taken to mean any living organism which may be administered and / or treated with compounds or compositions provided for herein. As such, the terms “patient” and “subject” may comprise, but is not limited to, any non-human mammal, primate or human. In some embodiments, the “patient” or “subject” is a mammal, such as mice, rats, other rodents, rabbits, dogs, cats, swine, cattle, sheep, horses, primates, or humans. In some embodiments, the patient or subject is an adult, child, or infant. In some embodiments, the patient or subject is a human.Attorney Docket No.: 148548-001102

[0029] The term “preventing” may be taken to mean to prevent a specific disorder, disease or condition and / or prevent the recurrence of a specific disorder, disease or condition.

[0030] The term “treating” as used herein, refers to methods of treating a skin disorder or a systemic condition, and generally includes the administration of a compound or composition which reduces the frequency of, or delays the onset of, symptoms of a medical condition or enhance the texture, appearance, color, sensation, or hydration of the intended tissue treatment area of the tissue surface in a subject relative to a subject not receiving the compound or composition. This can include reversing, reducing, or arresting the symptoms, clinical signs, and underlying pathology of a condition in a manner to improve or stabilize a subject’s condition.

[0031] The term “unit dosage form” refers to physically discrete units suitable as a unitary dosage for human subjects and other animals, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect, in association with a suitable pharmaceutical excipient.

[0032] The term “antinausea medication” refers to a medication used to prevent or treat nausea and vomiting.

[0033] The term “antimotility drug” refers to a medication that slows down the movement of the gastrointestinal tract.

[0034] The term “bovine colostrum” refers to the first milk produced by cows after giving birth, which is rich in antibodies, growth factors, and nutrients.

[0035] The term “carrier matrix” refers to a substance or material used to deliver or support the active ingredients in a composition.

[0036] The term “dual GIP / GLP-1 receptor co-agonist” refers to a molecule that can activate both the gastric inhibitory polypeptide (GIP) receptor and the glucagon-like peptide- 1 (GLP-1) receptor.

[0037] The term “gastric inhibitory polypeptide (GIP) receptor agonist” refers to a molecule that activates the GIP receptor, which may influence insulin secretion and metabolism. GIP receptor agonists may include tirzepatide, NN9471, RO5395649, LY3298176, NNC0090- 2746, and combinations thereof.

[0038] The term “glucagon-like peptide- 1 (GLP-1) receptor agonist” refers to a molecule that activates the GLP-1 receptor, which may influence insulin secretion, appetite, and metabolism. GLP-1 receptor agonists may include exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0039] The term “H2 receptor blocker” refers to a medication that reduces stomach acid production by blocking histamine H2 receptors. H2 receptor blockers may include omeprazole, simethicone, cimetidine, ranitidine, famotidine, nizatidine, and roxatidine.Attorney Docket No.: 148548-001102

[0040] The term “IgY antibody” refers to an immunoglobulin found in birds, reptiles, and amphibians that is functionally similar to mammalian IgG.

[0041] The term “non-absorbable antibiotic” refers to an antibiotic that is not absorbed by the body and acts locally in the gastrointestinal tract. Non-absorbable antibiotics may include rifaximin, neomycin, vancomycin, paromomycin, colistin, gentamicin, kanamycin, streptomycin, polymyxin B, bacitracin, and combinations thereof.

[0042] The term “prebiotic” refers to a type of fiber that feeds beneficial bacteria in the gut. Prebiotics may support gut health by promoting the growth of beneficial bacteria, improving digestion, and potentially enhancing immune function. In some cases, prebiotics may be added to foods or supplements to provide additional health benefits. Prebiotics may include inulin, fructooligosaccharides (FOS), galactooligosaccharides (GOS), resistant starch, pectin, beta-glucans, xylooligosaccharides (XOS), arabinoxylan, isomalto-oligosaccharides (IMO), human milk oligosaccharides (HMO). Inulin is found in chicory root, Jerusalem artichokes, onions, and garlic. Fructooligosaccharides (FOS) are present in bananas, onions, and asparagus. Galactooligosaccharides (GOS) are found in legumes and some dairy products. Resistant starch is present in green bananas, cooked and cooled potatoes, and legumes. Pectin is found in apples, citrus fruits, and berries. Beta-glucans are present in oats, barley, and certain mushrooms. Xylooligosaccharides (XOS) are derived from com cobs, bamboo shoots, and hardwoods. Arabinoxylan is found in wheat bran and other cereal grains. Isomalto-oligosaccharides (IMO) are present in some fermented foods and honey. Human milk oligosaccharides (HMO) are naturally occurring in human breast milk.

[0043] The term “prokinetic medication” refers to a drug that enhances gastrointestinal motility. Prokinetic medications may include metoclopramide, domperidone, cisapride, erythromycin, prucalopride, tegaserod, mosapride, itopride, bethanechol, and levosulpiride.

[0044] The term “small intestinal bacterial overgrowth (SIBO)” refers to a condition in which there is an excessive amount of bacteria in the small intestine.

[0045] It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as “open” terms (for example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claimAttorney Docket No.: 148548-001102 recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (for example, “a” and / or “an” should be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “ a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “ a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.”

[0046] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0047] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, etc. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc. As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges which can be subsequently broken down intoAttorney Docket No.: 148548-001102 subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 cells refers to groups having 1, 2, or 3 cells. Similarly, a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.

[0048] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.

[0049] By hereby reserving the right to proviso out or exclude any individual members of any such group, including any sub-ranges or combinations of sub-ranges within the group, that can be claimed according to a range or in any similar manner, less than the full measure of this disclosure can be claimed for any reason. Further, by hereby reserving the right to proviso out or exclude any individual substituents, analogs, compounds, ligands, structures, or groups thereof, or any members of a claimed group, less than the full measure of this disclosure can be claimed for any reason.

[0050] Throughout this disclosure, various patents, patent applications and publications are referenced. The disclosures of these patents, patent applications and publications in their entireties are incorporated into this disclosure by reference in order to more fully describe the state of the art as known to those skilled therein as of the date of this disclosure. This disclosure will govern in the instance that there is any inconsistency between the patents, patent applications and publications cited and this disclosure.

[0051] For convenience, certain terms employed in the specification, examples and claims are collected here. Unless defined otherwise, all technical and scientific terms used in this disclosure have the same meanings as commonly understood by one of ordinary skill in the art to which this disclosure belongs.COMPOSITIONS

[0052] The compositions described herein may be used in any of the methods or kits disclosed herein. Further, compositions of U.S. Patent Nos. 9,701,735 and 10,611,828 and U.S. Patent Application No. 17 / 433,723, the disclosures of each of which are incorporated by reference in their entirety, may be used in any of the methods or kits disclosed herein.

[0053] Aspects described herein are directed to a composition including an effective amount of a colostrum product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein theAttorney Docket No.: 148548-001102 pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0054] Aspects described herein are directed to a composition including an effective amount of an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0055] Aspects described herein are directed to a composition including an effective amount of a colostrum product and an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0056] In some aspects, the techniques described herein relate to a composition, wherein the colostrum product is a bovine colostrum product. In some aspects, the techniques described herein relate to a composition, wherein the colostrum product is a human colostrum product.

[0057] Compositions are provided comprising dried bovine colostrum and dried egg. The compositions may be useful as nutritional compositions or pharmaceutical compositions. The egg may include immune egg and / or non-hyperimmune egg. The bovine colostrum may include non-hyperimmune colostrum and / or hyperimmune colostrum. In one embodiment, the composition includes immune egg and non-hyperimmune colostrum. In one embodiment, the composition includes dried immune egg and dried non-hyperimmune colostrum. In one embodiment, the composition includes dried non-hyperimmune egg and dried hyperimmune bovine colostrum. In one embodiment, the composition includes dried non-hyperimmune egg and dried non-hyperimmune bovine colostrum. The dried egg may be dried chicken egg. The dried egg may include dried whole egg, dried egg yolk, and / or dried egg white. The dried egg may be dried whole egg. The dried egg may be dried egg yolk alone. The dried egg may be dried egg white alone. The dried egg may be dried pasteurized egg. The dried pasteurized egg may include dried pasteurized whole egg. The dried egg may be dried pasteurized raw whole egg. The driedAttorney Docket No.: 148548-001102 egg may be fractionated dried pasteurized raw whole egg. The fractionated dried egg may be whole egg separated into separate fractions of, for example, >30kDa, 10-30 kDa, 5-10 kDa and < 5 kDa, by any suitable means. In some embodiments, the dried egg is not dried-cooked egg. The dried egg may be, for example, spray-dried egg, lyophilized egg, and / or freeze-dried egg. The dried egg may be dried powdered egg.

[0058] The dried colostrum may be dried bovine colostrum. The dried bovine colostrum may include non-hyperimmune colostrum; hyperimmune colostrum; whole, nondefatted colostrum; defatted colostrum; fractionated colostrum; immune milk; whole milk; fractionated milk; milk; whole hyperimmune colostrum, whole non-hyperimmune colostrum; non-defatted hyperimmune colostrum; or non-defatted non-hyperimmune colostrum. The dried bovine colostrum may be dried whole bovine colostrum. The dried colostrum may be dried whole bovine colostrum powder. The dried colostrum may include, for example, spray-dried colostrum, lyophilized colostrum, and / or freeze-dried colostrum. The dried bovine colostrum powder may be instantized and / or agglomerated. The dried bovine colostrum powder may be instantized and / or agglomerated dried whole colostrum powder.

[0059] The composition may include dried egg and dried colostrum and optionally one or more additional active components as provided herein.

[0060] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product includes subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.

[0061] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulin, casein, IgG, lactoferrin, lactoperoxidase, a-lactalbumin, glycomacropeptide, [:l- lactoglobulin, growth factor, and combinations thereof.

[0062] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

[0063] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

[0064] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.Attorney Docket No.: 148548-001102

[0065] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

[0066] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone- releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

[0067] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocyte-macrophage colony-stimulating factor, and interleukin 1 [i, interleukin 6, interleukin 10, colostrinin / proline-rich polypeptide (PRP), and combinations thereof.

[0068] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulin-like growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor [3, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

[0069] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a whole egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a fowl egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a chicken egg.

[0070] In some aspects, the techniques described herein relate to a composition, wherein the egg product includes subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

[0071] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin, ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.

[0072] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.Attorney Docket No.: 148548-001102

[0073] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a vitamin, and the vitamin is selected from vitamin Bl 2, vitamin D, riboflavin, choline, and combinations thereof.

[0074] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

[0075] In some aspects, the techniques described herein relate to a composition, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

[0076] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

[0077] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

[0078] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth facto r-[:S (TGF-[3), and combinations thereof.

[0079] In some aspects, the techniques described herein relate to a composition, wherein the egg product is an immune egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a hyperimmune egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a non-hyperimmune egg.

[0080] Aspects described herein are directed to a composition including an effective amount of a bovine colostrum, wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0081] Aspects described herein are directed to a composition including an effective amount of an egg product, wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus,Attorney Docket No.: 148548-001102 Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof.

[0082] Aspects described herein are directed to a composition including an effective amount of an egg product and a bovine colostrum, wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0083] In some aspects, the techniques described herein relate to a composition, wherein the at least one specific avian antibody, or antigen binding fragment thereof, is specific for a pathogenic component from one, two, three, four, five, six, seven, or eight of different pathogenic microorganisms.

[0084] In some aspects, the techniques described herein relate to a composition, wherein the pathogen related toxin includes an endotoxin or exotoxin. In some aspects, the techniques described herein relate to a composition, wherein the pathogen related adhesion element includes one or more adhesins, cadherins, cilia, fimbrillae, or viral adhesin structures. In some aspects, the immune egg antibody product may include antibodies, or antigen-binding fragments thereof that are specific for an antigenic region derived from a pathogenic organism, undesirable strain, pathogen related toxin, or pathogen related adhesin element. The pathogen may be a human or veterinary, enteric or gastrointestinal, pathogen causing gastroenteritis. The pathogen may relate to normal colonic bacteria that have colonized the small intestine to cause symptoms and problems.

[0085] In some aspects, the immune egg antibody product may include antibodies, or antigen-binding fragments thereof that bind to an antigenic region of a pathogenic component selected from the group consisting of a pathogenic organism, a pathogen-related toxin, a pathogen- related adhesion element, and combinations thereof.Attorney Docket No.: 148548-001102

[0086] In some aspects, the pathogenic organism is selected from the group consisting of rotavirus, norovirus, calicivirus, enteric adenovirus, coronavirus, parvovirus, cytomegalovirus, astrovirus, herpes virus, Acanthamoeba spp., Aeromonas spp., Alternaria spp., Ancylostoma spp., Ascaris spp., Aspergillus spp., Bacillus spp., Byssochlamys spp., Campylobacter spp., Candida spp., Chlamydia spp., Claviceps spp., Clostridium spp., Cryptosporidium spp., Cyclospora spp., E. coli spp., Entamoeba spp., Fusarium spp., Gardnerella spp., Giardia spp., Gibberella spp., Helicobacter ssp., Klebsiella ssp., Listeria spp., Mycoplasma spp., Necator spp., Neisseria spp., Penicillium spp., Plesiomonas spp., Salmonella spp., Shigella spp., Staphylococcus spp., Streptococcus spp., Taenia spp., Trichomonas spp., Vibrio spp., Yersinia spp., Bacteroides spp., Peptostreptococcus , Lactobacillus spp., Enterobacterium and combinations thereof.

[0087] In some aspects, the pathogenic organism is selected from the group consisting oi Aeromonas hydrophila, Ancylostoma caninum, Ancylostoma duodenale, Ascaris lumbricoides, Bacillus thuringiensis , Campylobacter jejuni, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Chlamydia trachomatis, Clostridium difficile, Clostridium perfringens, typical EPEC strains, atypical EPEC (aEPEC) strains, Helicobacter pylori, Listeria monocytogenes, Necator americanus, Neisseria gonorrhoeae, Plesiomonas shigelloides, Salmonella enterica serovar Typhi, Salmonella typhimurium, Salmonella enterica serovar Typhi, Shigella dysenteriae, Staphylococcus aureus, Taenia saginata, Taenia solium, Trichomonas vaginalis, Vibrio cholerae 01, Vibrio cholerae 0139, Vibrio parahaemolyticus, Yersinia enterocolitica, and combinations thereof.

[0088] In some aspects, the pathogen-related toxin is selected from the group consisting of alpha toxin, Alternaria mycotoxin, Aspergillus mycotoxin, Bacillus thuringiensis delta endotoxin, Byssochlamys mycotoxin, Campylobacter jejuni enterotoxin, Cholera toxin, Claviceps mycotoxin, Clostridium perfringens enterotoxin, endotoxin from gram negative bacteria, E. coli heat stable enterotoxins LT and LT-II, Fusarium mycotoxin, Gibberella mycotoxin, Penicillium mycotoxin, perfringolysin O produced by Clostridium perfringens type C or type B, Shiga toxin, Staphylococcus enterotoxin B, and combinations thereof.

[0089] In some aspects, wherein the pathogen-related toxin is selected from the group consisting of an enterotoxin, endotoxin, exotoxin, and combinations thereof.

[0090] In some aspects, the pathogen-related adhesion element is selected from the group consisting of E. coli K99 pili adherence factor, E. coli K88 pili adherence factor, E. coli 987P pili adherence factor, E. coli F41 pili adherence factor, E. coli F41 pili adherence factor, and combinations thereof.Attorney Docket No.: 148548-001102

[0091] In some aspects, the pathogen-related adhesion element is selected from the group consisting of one or more adhesins, cadherins, cilia, fimbrillae, viral adhesin structures, and combinations thereof.

[0092] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum is whole bovine colostrum.

[0093] In some aspects, the techniques described herein relate to a composition, wherein the bovine colostrum is whole non-hyperimmune bovine colostrum.

[0094] In some aspects, the techniques described herein relate to a composition, wherein the egg product is a whole egg.

[0095] In some aspects, the techniques described herein relate to a composition, wherein the whole egg is a pasteurized raw dried whole egg powder.

[0096] In some aspects, the techniques described herein relate to a composition, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1:10 to about 10:1.

[0097] In some aspects, the techniques described herein relate to a composition, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis of about 3:2. In some aspects, the techniques described herein relate to a composition, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1 : 10 to about 10:1 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose. In some aspects, the techniques described herein relate to a composition, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 3:2 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

[0098] In some aspects, the techniques described herein relate to a composition, wherein the composition comprises bovine colostrum in an amount of about 30% to about 70% of the total composition. In some aspects, the composition comprises bovine colostrum in an amount of about 50% to 60% of the total composition. In some aspects, the composition comprises bovine colostrum in an amount of about 55% of the total composition. In some aspects, the composition comprises bovine colostrum in an amount of about 30%, about 35%, about 40%, about 45%, about 50%, about 51%, about 52%, about 53%, about 54%, about 55%, about 56%, about 57%, about 58%, about 59%, about 60%, about 65%, about 70%, and ranges between any two of these values.

[0099] In some aspects, the techniques described herein relate to a composition, wherein the composition comprises immune egg antibody in an amount of about 20% to aboutAttorney Docket No.: 148548-00110260% of the total composition. In some aspects, the composition comprises bovine colostrum in an amount of about 40% to 50% of the total composition. In some aspects, the composition comprises bovine colostrum in an amount of about 42% of the total composition. In some aspects, the composition comprises immune egg antibody in an amount of about 20%, about 25%, about 30%, about 35%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, about 46%, about 47%, about 48%, about 49%, about 50%, about 55%, about 60%, and ranges between any two of these values.

[0100] Aspects described herein are directed to a composition including an effective amount of a mixture of an IgY antibody and a carrier matrix derived from bovine colostrum; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0101] In some aspects, the techniques described herein relate to a composition, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen-related toxins, pathogen-related adhesion elements, or combinations thereof.

[0102] In some aspects, the techniques described herein relate to a composition, wherein the IgY antibody is present in a concentration effective to neutralize pathogens, toxins, or adhesion elements in a gastrointestinal tract.

[0103] In some aspects, the techniques described herein relate to a composition, wherein the carrier matrix further includes one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants.

[0104] In some aspects, the techniques described herein relate to a composition, wherein the carrier matrix is formulated to protect the IgY antibody from degradation in a stomach and to facilitate release of at least one specific binding molecule in an intestine.

[0105] In any aspect, the techniques described herein relate to a composition comprising a colostrum product, an egg product, and a combination of an egg product and a colostrum product as described in any aspect disclosed herein. In some aspects, the composition further comprises a pharmaceutical agent. In any aspect, the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.Attorney Docket No.: 148548-001102

[0106] In any aspect, the techniques described herein relate to a composition comprising a colostrum product, an egg product, and a combination of an egg product and a colostrum product as described in any aspect disclosed herein. In some aspects, the composition further comprises an additional active agent.

[0107] In some aspects, the techniques described herein relate to a composition, wherein the composition further includes one or more additional active agents. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents is an H2 receptor blocker. In some aspects, the techniques described herein relate to a composition, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents is an antinausea medication. In some aspects, the techniques described herein relate to a composition, wherein the antinausea medication is ondansetron. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents is a prokinetic medication. In some aspects, the techniques described herein relate to a composition, wherein the prokinetic medication is metoclopramide. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents is an antimotility drug. In some aspects, the techniques described herein relate to a composition, wherein the one or more active agents is a non-absorbable antibiotic. In some aspects, the techniques described herein relate to a composition, wherein the non-absorbable antibiotic is rifaximin.

[0108] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises an additional active agent. In some aspects, the additional active agent is selected from one or more of an antibiotic drug, antifungal drug, antimicrobial drug, antiparasitic drug, antiprotozoal drug, antiviral drug, bacteriocin, micronutrient, oral rehydration salt, antidiarrheal adsorbent, anticholinergic, antimotility drug, isolated egg bioactive molecule, additional non-immunoglobulin colostrum component, n-3 LC- PUFA, probiotic, secondary bile acid, antisecretory agent, non-steroidal anti-inflammatory drug (NSAID), COX -2 inhibitors, and combinations thereof.

[0109] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises an antibiotic. In some aspects, the antibiotic may be selected from the group consisting of ampicillin, clindamycin, fluoroquinolone, cephalosporin, prulifloxacin, ulifloxacin, fidaxomicin, minocyclin, metronidazole, sulfamethoxazole, trimethoprim, ofloxacin, norfloxacin, tinidazole, norfloxacin, ofloxacin, ornidazole,Attorney Docket No.: 148548-001102 levofloxacin, nalidixic acid, ceftriaxone, azithromycin, cefixime, ceftriaxone, cefalexin, ceftriaxone, rifaximin, ciprofloxacin, norfloxacin, ofloxacin, levofloxacin, gatifloxacin, gemifloxacin, prufloxacin, ulifloxacin, and moxifloxacin, or a combination thereof.

[0110] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises an antifungal drug. In some aspects, the antifungal drug may be selected from nystatin, amphotericin B, flucytosine, ketoconazole, posaconazole, clotrimazole, voriconazole, griseofulvin, miconazole nitrate, and fluconazole, or a combination thereof.

[0111] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises an anti-microbial drug. In some aspects, the antimicrobial drug may be selected from the group consisting of metronidazole, tinidazole, nitazoxanide, satranidazole, ornidazole, ofloxocin, diloxanide furoate, tetracycline, trimethoprim, sulfamethoxazole, albendazole, rifampicin, secnidazole, paromomycin, ciprofloxacin, diloxanide furoate, and fumagillin, and combinations thereof.

[0112] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises an NSAID. In some aspects, the NS AID is selected from the group consisting of aspirin, ibuprofen, naproxen, celecoxib, ketoprofen, indomethacin, and combinations thereof.

[0113] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises a COX-2 inhibitor. In some aspects, the COX-2 inhibitor is selected from the group consisting of celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, parecoxib, and combinations thereof.

[0114] In some aspects, the techniques described herein relate to a composition, wherein the composition further comprises a micronutrient. In some aspects, the micronutrient may be selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin B12, vitamin B6, riboflavin, niacin, pantothenic acid, thiamine, choline, folic acid, biotin, vitamin K, vitamin C, cobalt, copper, iron, manganese, iodine, calcium, magnesium, phosphorus, a zinc supplement, and selenium, or any combination thereof. In some aspects, the techniques described herein relate to a composition, wherein the method further includes administering one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants. In some aspects, the techniques described herein relate to a composition, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof. In some aspects, the techniques described herein relate to a composition, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg. In some aspects, the techniques described herein relate to a composition, wherein the vitamin C is in an amount ofAttorney Docket No.: 148548-001102 about 15 mg to about 60 mg. In some aspects, the techniques described herein relate to a composition, wherein the folic acid is in an amount of about 80 pg to about 600 pg. In some aspects, the techniques described herein relate to a composition, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

[0115] In some aspects, the techniques described herein relate to a composition, wherein the iron is in an amount of about 0.5 mg to about 18 mg. In some aspects, the micronutrient comprises vitamin A, about 100 pg to about 1000 pg; vitamin C, about 15 mg to about 60 mg; folic acid, about 80 pg to about 600 pg; iron, about 0.5 mg to about 18 mg; and zinc, about 1 mg to about 50 mg. In some aspects, the micronutrient comprises vitamin A, about 200 pg to about 400 pg; vitamin C, about 20 mg to about 40 mg; folic acid, about 140 pg to about 180 pg; iron, about 5 mg to about 15 mg; and zinc, about 5 mg to about 20 mg.

[0116] In some aspects, the micronutrient comprises Vitamin A, 300 pg; Vitamin D, 5 pg; Vitamin E, 6 mg; Vitamin C, 30 mg; Thiamin, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B-6, 0.5 mg; Vitamin B-12, 0.5 pg; Niacin, 6 mg; Folic acid, 160 pg; Iron, 10 mg; Zinc, 10 mg; Copper, 0.5 mg; Selenium, 20 pg; Iodine, 90 pg; Calcium, 100 mg; Magnesium, 20 mg; Phosphorus, 100 mg; Manganese, 0.6 mg; Vitamin K, 20 pg; Pantothenic acid, 1.8 mg; and Biotin, 6 pg.

[0117] In some aspects, the micronutrient comprises Vitamin A, 100 to 1000 pg; Vitamin D, 2 to 25 pg; Vitamin E, 3 to 15 mg; Vitamin C, 15 to 60 mg; Thiamin, 0.2 to 1.5 mg; Riboflavin, 0.2 to 1.3 mg; Vitamin B-6, 0.2 to 2 mg; Vitamin B-12, 0.2 to 5 pg; Niacin, 3 to 16 mg; Folic acid, 80 to 600 pg; Iron, 0.5 to 18 mg; Zinc, 1 to 50 mg; Copper, 0.2 to 1.6 mg; Selenium, 10 to 80 pg; Iodine, 45 to 290 pg; Calcium, 50 to 1300 mg; Magnesium, 10 to 420 mg; Phosphorus, 50 to 1250 mg; Manganese, 0.3 to 2.6 mg; Vitamin K, 2 to 120 pg; Pantothenic acid, 0.9 to 7 g; and Biotin, 3 to 35 pg.

[0118] In some aspects, the micronutrient comprises Vitamin A, 300 pg; Vitamin D, 5 pg; Vitamin E, 6 mg; Vitamin C, 30 mg; Thiamin, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B-6, 0.5 mg; Vitamin B-12, 0.5 pg; Niacin, 6 mg; Folic acid, 160 pg; Iron, 10 mg; Zinc, 10 mg; Copper, 0.5 mg; Selenium, 20 pg; Iodine, 90 pg; Calcium, 100 mg; Magnesium, 20 mg; Phosphorus, 100 mg; Manganese, 0.6 mg; Vitamin K, 20 pg; Pantothenic acid, 1.8 mg; and Biotin, 6 pg.

[0119] In some aspects, the micronutrient may comprise zinc in the form of a zinc supplement selected from an inorganic zinc salts and / or organic zinc salts. The inorganic zinc salts may be zinc sulfate or zinc oxide. The organic zinc salts may be zinc camosine, zinc acetate, zinc gluconate, zinc monomethionine, zinc picolinate, or zinc glycinate. In a specific aspect the zinc supplement may be zinc L-carnosine. The zinc supplement may be zinc sulfate, zinc oxide, zinc carnosine, zinc acetate, zinc gluconate, zinc monomethionine, zinc picolinate, and zinc glycinate.Attorney Docket No.: 148548-001102

[0120] In some aspects, composition may further comprise an oral rehydration salt. The oral rehydration salt may be selected from the group consisting of sodium chloride, potassium citrate, potassium chloride, and sodium citrate, or a combination thereof.

[0121] In some aspects, the composition further comprises a antidiarrheal adsorbent. The antidiarrheal absorbent may be selected from the group consisting of bismuth subsalicylate, kaolin, attapulgite and pectin, or a combination thereof.

[0122] In some aspects, the composition further comprises a anticholinergic drug. The anticholinergic drug may be selected from the group consisting of a belladonna alkaloid, atropine and hyoscyamine, or a combination thereof.

[0123] In some aspects, the composition further comprises a antisecretory agent selected from the group consisting of Racecadotril, Crofelemer, iOWH032, albumin tannate, Sulfasalazine, Mesalazine, Olsalazine, and Octreotide, or a combination thereof.

[0124] In some aspects, the techniques described herein relate to a composition, wherein the composition further includes a probiotic component including one or more live microorganisms. The probiotic may be selected from Saccharomyces spp., Bifidobacterium spp., Ruminococcaceae, Lactobacillus spp., optionally wherein the probiotic is selected from the group consisting of Saccharomyces boulardii, Bifidobacterium lactis, Ruminococcaceae, Lactobacillus acidophilus, Lactobacillus plantarum, and Lactobacillus casei. In some aspects, the probiotic may be a SBA producing bacteria. The SBA producing bacteria may be a Ruminococcaceae, optionally a Ruminococcus spp. , such as Ruminococcus albus, Ruminococcus callidis, Ruminococcus bromii. The additional active agent may be a secondary bile acid (SBA). The SBA may be, for example, deoxycholic acid (DCA) or lithocholic acid (LCA).

[0125] In some aspects, the composition further comprises an agent selected from the group consisting of Nitazoxanide, Nelumbo nucifera Gaertn., Aspalathus linearis (Burm.f.) R. Dahlgren, Urtica dioica L., Glycyrrhiza glabra L., Olea europaea L; luteolin, vitexin, and apigenin 7-O-glucoside.

[0126] In some aspects, the techniques described herein relate to a method, wherein the composition further includes a prebiotic component including one or more types of dietary fiber.METHODS OF USE

[0127] Any embodiment directed to a method of treating gastrointestinal side effects of any pharmaceutical agent described herein, the method including administering to a subject an effective amount of a composition, wherein the composition is any composition described hereinAttorney Docket No.: 148548-001102 or in U.S. Patent Nos. 9,701,735 and 10,611,828 and U.S. Patent Application No. 17 / 433,723, the disclosures of each of which are incorporated by reference in their entirety.

[0128] Aspects described herein are directed to a method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition, wherein the composition includes an effective amount of a colostrum product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0129] Aspects described herein are directed to a method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition, wherein the composition includes an effective amount of an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof.

[0130] Aspects described herein are directed to a method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition, wherein the composition includes an effective amount of a colostrum product and an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0131] In some aspects, the techniques described herein relate to a method, wherein the colostrum product is a bovine colostrum product. In some aspects, the techniques described herein relate to a method, wherein the colostrum product is a human colostrum product.

[0132] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product includes subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.

[0133] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulins, casein, IgG, lactoferrin, lactoperoxidase, a-lactalbumin, glycomacropeptide, P-lactoglobulin, growth factors, and combinations thereof.Attorney Docket No.: 148548-001102

[0134] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

[0135] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

[0136] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.

[0137] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

[0138] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

[0139] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocyte-macrophage colony-stimulating factor, and interleukin 1 [i, interleukin 6, interleukin 10, colostrinin / proline-rich polypeptide (PRP), and combinations thereof.

[0140] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulinlike growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor [3, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

[0141] In some aspects, the techniques described herein relate to a method, wherein the egg product is a whole egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a fowl egg. In some aspects, the techniques described herein relate to a composition, wherein the egg product is a chicken egg.

[0142] In some aspects, the techniques described herein relate to a method, wherein the egg product includes subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

[0143] In some aspects, the techniques described herein relate to a method, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin,Attorney Docket No.: 148548-001102 ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.

[0144] In some aspects, the techniques described herein relate to a method, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.

[0145] In some aspects, the techniques described herein relate to a method, wherein the egg product is a vitamin, and the vitamin is selected from vitamin Bl 2, vitamin D, riboflavin, choline, and combinations thereof.

[0146] In some aspects, the techniques described herein relate to a method, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

[0147] In some aspects, the techniques described herein relate to a method, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

[0148] In some aspects, the techniques described herein relate to a method, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

[0149] In some aspects, the techniques described herein relate to a method, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

[0150] In some aspects, the techniques described herein relate to a method, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth factor-fl (TGF-P), and combinations thereof.

[0151] In some aspects, the techniques described herein relate to a method, wherein the egg product is an immune egg. In some aspects, the techniques described herein relate to a method, wherein the egg product is a hyperimmune egg. In some aspects, the techniques described herein relate to a method, wherein the egg product is a non-hyperimmune egg.

[0152] In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition includes colostrum product and egg product in a ratio of about 1:10 to about 10:1. In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition includes colostrum product and egg product in a ratio of about 3:2.Attorney Docket No.: 148548-001102

[0153] In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition comprises colostrum product in an amount of about 30% to about 70% of the total composition. In some aspects, the composition comprises colostrum product in an amount of about 50% to 60% of the total composition. In some aspects, the composition comprises colostrum product in an amount of about 55% of the total composition. In some aspects, the composition comprises colostrum product in an amount of about 30%, about 35%, about 40%, about 45%, about 50%, about 51%, about 52%, about 53%, about 54%, about 55%, about 56%, about 57%, about 58%, about 59%, about 60%, about 65%, about 70%, and ranges between any two of these values.

[0154] In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition comprises egg product in an amount of about 20% to about 60% of the total composition. In some aspects, the composition comprises egg product in an amount of about 40% to 50% of the total composition. In some aspects, the composition comprises egg product in an amount of about 42% of the total composition. In some aspects, the composition comprises egg product in an amount of about 20%, about 25%, about 30%, about 35%, about 40%, about 41%, about 42%, about 43%, about 44%, about 45%, about 46%, about 47%, about 48%, about 49%, about 50%, about 55%, about 60%, and ranges between any two of these values.

[0155] Aspects described herein are directed to a method of treating gastrointestinal side effects of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition including a bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0156] Aspects described herein are directed to a method of treating gastrointestinal side effects of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition including an egg product, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroid.es, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxin, pathogen related adhesion element, or combinations thereof.Attorney Docket No.: 148548-001102

[0157] Aspects described herein are directed to a method of treating gastrointestinal side effects of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition including an egg product and a bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxin, pathogen related adhesion element, or combinations thereof.

[0158] In some aspects, the techniques described herein relate to a method, wherein the at least one specific avian antibody or antigen binding fragment thereof, is specific for a pathogenic component from one, two, three, four, five, six, seven, or eight of different pathogenic microorganisms.

[0159] In some aspects, the techniques described herein relate to a method, wherein the pathogen related toxin includes an endotoxin or exotoxin.

[0160] In some aspects, the techniques described herein relate to a method, wherein the pathogen related adhesion element includes one or more adhesins, cadherins, cilia, fimbrillae, or viral adhesin structures.

[0161] In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum is whole bovine colostrum. In some aspects, the techniques described herein relate to a method, wherein the bovine colostrum is whole non-hyperimmune bovine colostrum. In some aspects, the techniques described herein relate to a method, wherein the egg product is a whole egg. In some aspects, the techniques described herein relate to a method, wherein the whole egg is a pasteurized raw dried whole egg powder.

[0162] In some aspects, the techniques described herein relate to a method, wherein the composition has a weight ratio of colostrum product to egg product, on a dry weight equivalent basis, of about 1:10 to about 10:1. In some aspects, the techniques described herein relate to a method, wherein the composition has a weight ratio of colostrum product to egg product, on a dry weight equivalent basis, of about 3:2. In some aspects, the techniques described herein relate to a method, wherein the composition has a weight ratio of colostrum product to egg product, on a dry weight equivalent basis, of about 1:10 to about 10:1 of a combined weight of the egg product and the colostrum product on a dry weight equivalent basis per dose. In some aspects, the techniques described herein relate to a method, wherein the composition has a weight ratio of colostrumAttorney Docket No.: 148548-001102 product to egg product, on a dry weight equivalent basis, of about 3:2 of a combined weight of the egg product and the colostrum product on a dry weight equivalent basis per dose.

[0163] In some aspects, the techniques described herein relate to a method, wherein the subject is treated and one or more changes are induced, wherein the one or more changes are selected from the group consisting of decreased enteric inflammation, change in intestinal microbiome, decreased blunting of intestinal villi, increased intestinal integrity, decreased ulceration, decreased leakage of intestinal contents, decreased systemic inflammation, increased weight-for-age z-score, increased height-for-age z-score, increased weight-for-height z-score, increased mid-upper arm circumference, change in antigen-specific antibody titer in the subject, reduction of abdominal pain, increase in physician-assessed well-being of the subject, decreased abnormal flattening of villi, decreased inflammation of a lining of small intestine, and decreased presence of inflammatory cells in biopsy of small intestine tissue, or a combination thereof.

[0164] Aspects described herein are directed to a method for treating gastrointestinal side effects of a pharmaceutical agent, the method including administering to a subject an effective amount of a composition, wherein the composition includes an effective amount of a mixture of IgY antibody and a carrier matrix derived from bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of the pharmaceutical agent.

[0165] In some aspects, the techniques described herein relate to a method, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0166] In some aspects, the techniques described herein relate to a method, wherein the IgY antibody is present in a concentration effective to neutralize pathogens, toxins, or adhesion elements in a gastrointestinal tract.

[0167] In some aspects, the techniques described herein relate to a method, wherein the carrier matrix further includes one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants.

[0168] In some aspects, the techniques described herein relate to a method, wherein the carrier matrix is formulated to protect the IgY antibody from degradation in a stomach and to facilitate release of at least one specific binding molecule in an intestine.Attorney Docket No.: 148548-001102

[0169] In some aspects, the techniques described herein relate to a method, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0170] In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition includes colostrum product and egg product in a ratio of about 1:10 to about 10: 1.

[0171] In some aspects, the techniques described herein relate to a method, wherein the effective amount of the composition includes colostrum product and egg product in a ratio of about 3:2.

[0172] In some aspects, the techniques described herein relate to a method, wherein the subject is being treated with the pharmaceutical agent for diabetes or weight loss. In some aspects, the techniques described herein relate to a method, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0173] In some aspects, the techniques described herein relate to a method, wherein the composition is used to manage the gastrointestinal side effects associated with the pharmaceutical agent without use of additional pharmaceuticals for symptom relief. In some aspects, the techniques described herein relate to a method, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

[0174] In some aspects, the techniques described herein relate to a method, wherein the composition is administered without requiring a dosage adjustment of the pharmaceutical agent.

[0175] In some aspects, the techniques described herein relate to a method, wherein the composition is administered orally.

[0176] In some aspects, the techniques described herein relate to a method, wherein the composition is used to manage gastrointestinal side effects without additional pharmaceuticals for symptom relief.

[0177] In some aspects, the techniques described herein relate to a method, wherein the composition is administered at the same time as administration of the pharmaceutical agent. In some aspects, the techniques described herein relate to a method, wherein the composition is administered prior to administration of the pharmaceutical agent. In some aspects, the techniques described herein relate to a method, wherein the composition is administered subsequent to administration of the pharmaceutical agent. In some aspects, the techniques described herein relate to a method, wherein the composition is administered at regular intervals throughout a day. In some aspects, the techniques described herein relate to a method, wherein the composition isAttorney Docket No.: 148548-001102 administered once per week. In some aspects, the techniques described herein relate to a method, wherein the composition is administered about once per week to about 7 times per week. In some aspects, the techniques described herein relate to a method, wherein the composition is administered as needed to manage gastrointestinal side effects. In some aspects, the techniques described herein relate to a method, wherein the composition is administered once per day. In some aspects, the techniques described herein relate to a method, wherein the composition is administered multiple times per day. In some aspects, the techniques described herein relate to a method, wherein the composition is administered twice per day. In some aspects, the techniques described herein relate to a method, wherein the composition is administered four twice per day. In some aspects, the techniques described herein relate to a method, wherein the composition is administered as a single dose.

[0178] In some aspects, the techniques described herein relate to a method, wherein the single dose of the composition is about 1 g to about 28 g. In some aspects, the techniques described herein relate to a method, wherein the single dose of the composition is about 7 g to about 14 g. In some aspects, the techniques described herein relate to a method, wherein the single dose of the composition is about 7 g. In some aspects, the effective amount of the composition comprises from 1 g to 50 g, 4 g to 30 g, 5 g to 20 g, or 6 g to 15 g of combined weight of the egg product and the colostrum on a dry weight equivalent basis per dose.

[0179] In some aspects, the techniques described herein relate to a method, wherein the composition is administered in a regimen adjusted based on a severity of the gastrointestinal side effects experienced by the subject.

[0180] In some aspects, the techniques described herein relate to a method, wherein the composition further includes one or more additional active agents. In some aspects, the techniques described herein relate to a method, wherein the one or more active agents is an H2 receptor blocker. In some aspects, the techniques described herein relate to a method, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof. In some aspects, the techniques described herein relate to a method, wherein the one or more active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof. In some aspects, the techniques described herein relate to a method, wherein the one or more active agents is an antinausea medication. In some aspects, the techniques described herein relate to a method, wherein the antinausea medication is ondansetron. In some aspects, the techniques described herein relate to a method, wherein the one or more active agents is a prokinetic medication. In some aspects, the techniques described herein relate to a method, wherein the prokinetic medication is metoclopramide. In some aspects, the techniques described herein relate to aAttorney Docket No.: 148548-001102 method, wherein the one or more active agents is an antimotility drug. In some aspects, the techniques described herein relate to a method, wherein the one or more active agents is a nonabsorbable antibiotic. In some aspects, the techniques described herein relate to a method, wherein the non-absorbable antibiotic is rifaximin.

[0181] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises an additional active agent. In some aspects, the additional active agent is selected from one or more of an antibiotic drug, antifungal drug, antimicrobial drug, antiparasitic drug, antiprotozoal drug, antiviral drug, bacteriocin, micronutrient, oral rehydration salt, antidiarrheal adsorbent, anticholinergic, antimotility drug, isolated egg bioactive molecule, additional non-immunoglobulin colostrum component, n-3 LC-PUFA, probiotic, secondary bile acid, antisecretory agent, non-steroidal anti-inflammatory drug (NSAID), COX-2 inhibitors, and combinations thereof.

[0182] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises an antibiotic. In some aspects, the antibiotic may be selected from the group consisting of ampicillin, clindamycin, fluoroquinolone, cephalosporin, prulifloxacin, ulifloxacin, fidaxomicin, minocyclin, metronidazole, sulfamethoxazole, trimethoprim, ofloxacin, norfloxacin, tinidazole, norfloxacin, ofloxacin, ornidazole, levofloxacin, nalidixic acid, ceftriaxone, azithromycin, cefixime, ceftriaxone, cefalexin, ceftriaxone, rifaximin, ciprofloxacin, norfloxacin, ofloxacin, levofloxacin, gatifloxacin, gemifloxacin, prufloxacin, ulifloxacin, and moxifloxacin, or a combination thereof.

[0183] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises an antifungal drug. In some aspects, the antifungal drug may be selected from nystatin, amphotericin B, flucytosine, ketoconazole, posaconazole, clotrimazole, voriconazole, griseofulvin, miconazole nitrate, and fluconazole, or a combination thereof.

[0184] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises an anti-microbial drug. In some aspects, the antimicrobial drug may be selected from the group consisting of metronidazole, tinidazole, nitazoxanide, satranidazole, ornidazole, ofloxocin, diloxanide furoate, tetracycline, trimethoprim, sulfamethoxazole, albendazole, rifampicin, secnidazole, paromomycin, ciprofloxacin, diloxanide furoate, and fumagillin, and combinations thereof.

[0185] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises an NSAID. In some aspects, the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, celecoxib, ketoprofen, indomethacin, and combinations thereof.Attorney Docket No.: 148548-001102

[0186] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises a COX-2 inhibitor. In some aspects, the COX-2 inhibitor is selected from the group consisting of celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, parecoxib, and combinations thereof.

[0187] In some aspects, the techniques described herein relate to a method, wherein the composition further comprises a micronutrient. In some aspects, the micronutrient may be selected from the group consisting of vitamin A, vitamin D, vitamin E, vitamin B12, vitamin B6, riboflavin, niacin, pantothenic acid, thiamine, choline, folic acid, biotin, vitamin K, vitamin C, cobalt, copper, iron, manganese, iodine, calcium, magnesium, phosphorus, a zinc supplement, and selenium, or any combination thereof. In some aspects, the techniques described herein relate to a method, wherein the method further includes administering one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants. In some aspects, the techniques described herein relate to a method, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof. In some aspects, the techniques described herein relate to a method, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg. In some aspects, the techniques described herein relate to a method, wherein the vitamin C is in an amount of about 15 mg to about 60 mg. In some aspects, the techniques described herein relate to a method, wherein the folic acid is in an amount of about 80 pg to about 600 pg. In some aspects, the techniques described herein relate to a method, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

[0188] In some aspects, the techniques described herein relate to a method, wherein the iron is in an amount of about 0.5 mg to about 18 mg. In some aspects, the micronutrient comprises vitamin A, about 100 pg to about 1000 pg; vitamin C, about 15 mg to about 60 mg; folic acid, about 80 pg to about 600 pg; iron, about 0.5 mg to about 18 mg; and zinc, about 1 mg to about 50 mg. In some aspects, the micronutrient comprises vitamin A, about 200 pg to about 400 pg; vitamin C, about 20 mg to about 40 mg; folic acid, about 140 pg to about 180 pg; iron, about 5 mg to about 15 mg; and zinc, about 5 mg to about 20 mg.

[0189] In some aspects, the micronutrient comprises Vitamin A, 300 pg; Vitamin D, 5 pg; Vitamin E, 6 mg; Vitamin C, 30 mg; Thiamin, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B-6, 0.5 mg; Vitamin B-12, 0.5 pg; Niacin, 6 mg; Folic acid, 160 pg; Iron, 10 mg; Zinc, 10 mg; Copper, 0.5 mg; Selenium, 20 pg; Iodine, 90 pg; Calcium, 100 mg; Magnesium, 20 mg; Phosphorus, 100 mg; Manganese, 0.6 mg; Vitamin K, 20 pg; Pantothenic acid, 1.8 mg; and Biotin, 6 pg.

[0190] In some aspects, the micronutrient comprises Vitamin A, 100 to 1000 pg; Vitamin D, 2 to 25 pg; Vitamin E, 3 to 15 mg; Vitamin C, 15 to 60 mg; Thiamin, 0.2 to 1.5 mg; Riboflavin, 0.2 to 1.3 mg; Vitamin B-6, 0.2 to 2 mg; Vitamin B-12, 0.2 to 5 pg; Niacin, 3 to 16Attorney Docket No.: 148548-001102 mg; Folic acid, 80 to 600 pg; Iron, 0.5 to 18 mg; Zinc, 1 to 50 mg; Copper, 0.2 to 1.6 mg; Selenium, 10 to 80 pg; Iodine, 45 to 290 pg; Calcium, 50 to 1300 mg; Magnesium, 10 to 420 mg; Phosphorus, 50 to 1250 mg; Manganese, 0.3 to 2.6 mg; Vitamin K, 2 to 120 pg; Pantothenic acid, 0.9 to 7 g; and Biotin, 3 to 35 pg.

[0191] In some aspects, the micronutrient comprises Vitamin A, 300 pg; Vitamin D, 5 pg; Vitamin E, 6 mg; Vitamin C, 30 mg; Thiamin, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B-6, 0.5 mg; Vitamin B-12, 0.5 pg; Niacin, 6 mg; Folic acid, 160 pg; Iron, 10 mg; Zinc, 10 mg; Copper, 0.5 mg; Selenium, 20 pg; Iodine, 90 pg; Calcium, 100 mg; Magnesium, 20 mg; Phosphorus, 100 mg; Manganese, 0.6 mg; Vitamin K, 20 pg; Pantothenic acid, 1.8 mg; and Biotin, 6 pg.

[0192] In some aspects, the micronutrient may comprise zinc in the form of a zinc supplement selected from an inorganic zinc salt and / or an organic zinc salt. The inorganic zinc salt may be zinc sulfate or zinc oxide. The organic zinc salt may be zinc carnosine, zinc acetate, zinc gluconate, zinc monomethionine, zinc picolinate, or zinc glycinate. In a specific aspect the zinc supplement may be zinc L-carnosine. The zinc supplement may be zinc sulfate, zinc oxide, zinc carnosine, zinc acetate, zinc gluconate, zinc monomethionine, zinc picolinate, and zinc glycinate.

[0193] In some aspects, the composition may further comprise an oral rehydration salt. The oral rehydration salt may be selected from the group consisting of sodium chloride, potassium citrate, potassium chloride, and sodium citrate, or a combination thereof.

[0194] In some aspects, the composition further comprises an antidiarrheal adsorbent. The antidiarrheal absorbent may be selected from the group consisting of bismuth subsalicylate, kaolin, attapulgite and pectin, or a combination thereof.

[0195] In some aspects, the composition further comprises an anticholinergic drug. The anticholinergic drug may be selected from the group consisting of a belladonna alkaloid, atropine and hyoscyamine, or a combination thereof.

[0196] In some aspects, the composition further comprises an antisecretory agent selected from the group consisting of Racecadotril, Crofelemer, iOWH032, albumin tannate,Sulfasalazine, Mesalazine, Olsalazine, and Octreotide, or a combination thereof.

[0197] In some aspects, the techniques described herein relate to a method, wherein the composition further includes a probiotic component including one or more live microorganisms. The probiotic may be selected from Saccharomyces spp., Bifidobacterium spp., Ruminococcaceae, or Lactobacillus spp., optionally wherein the probiotic is selected from the group consisting of Saccharomyces boulardii, Bifidobacterium lactis, Ruminococcaceae, Lactobacillus acidophilus, Lactobacillus plantarum, and Lactobacillus casei. In some aspects, the probiotic may be an SBA-producing bacteria. The SBA-producing bacteria may be aAttorney Docket No.: 148548-001102 Ruminococcaceae, optionally a Ruminococcus spp., such as Ruminococcus albus, Ruminococcus callidis, or Ruminococcus bromii. The additional active agent may be a secondary bile acid (SBA). The SBA may be, for example, deoxycholic acid (DCA) or lithocholic acid (LCA).

[0198] In some aspects, the composition further comprises an agent selected from the group consisting of Nitazoxanide, Nelumbo nucifera Gaertn., Aspalathus linearis (Burm.f.) R. Dahlgren, Urtica dioica L., Glycyrrhiza glabra L., Olea europaea L; luteolin, vitexin, and apigenin 7-O-glucoside.

[0199] In some aspects, the techniques described herein relate to a method, wherein the composition further includes a prebiotic component including one or more types of dietary fiber.

[0200] In some aspects, the techniques described herein relate to a method, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0201] In some aspects, the techniques described herein relate to a method, wherein the composition provides nutrients and immune factors that restore normal intestinal function. In some aspects, the techniques described herein relate to a method, wherein administering the composition protects a gut from irritation by pancreatic enzymes and bile.

[0202] In some aspects, the techniques described herein relate to a method, wherein the composition is marketed as a food for special dietary use.

[0203] In some aspects, the techniques described herein relate to a method, wherein the subject is an adult. In some aspects, the techniques described herein relate to a method, wherein the subject is a child.

[0204] In some aspects, the techniques described herein relate to a method, wherein administering the composition reduces small intestinal bacterial overgrowth of the subject. In some aspects, the techniques described herein relate to a method, wherein the gastrointestinal side effects of the administration of the pharmaceutical agent result from a small intestinal bacterial overgrowth (SIBO) of the subject. In some aspects, the techniques described herein relate to a method, wherein the SIBO is measured using hydrogen breath testing. In some aspects, the techniques described herein relate to a method, wherein the SIBO of the subject is >12ppm greater than a baseline or control measurement of SIBO after lactulose or the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge. In some aspects, the techniques described herein relate to a method, wherein the SIBO is measured by small intestine aspirate. In some aspects, the techniques described herein relate to a method, wherein the SIBO is measured by fluid culture. In some aspects, the techniques described herein relate to a method, wherein the SIBO is measured using methane breath testing. In some aspects, the SIBO is an overgrowth of a bacteria selected from the group consisting of Streptococcus,Attorney Docket No.: 148548-001102Escherichia coli, Staphylococcus, Bacteroid.es, Klebsiella, Enterococcus, Proteus, and combinations thereof.

[0205] In some aspects, the techniques described herein relate to a method, wherein the NSAID is a COX-2 inhibitor. In some aspects, the COX-2 inhibitor is selected from the group consisting of celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, parecoxib, and combinations thereof. In some aspects, the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, celecoxib, ketoprofen, indomethacin, and combinations thereof. In some aspects, the method treats or prevents a drug-induced injury. In some aspects, the NSAID drug- induced injury is selected from the group consisting of gastrointestinal bleeding, a bleeding ulcer, a gastrointestinal obstruction, a gastrointestinal perforation, gastrointestinal erosion, gastrointestinal tract mucosal injury, and combinations thereof. In some aspects, the method further includes administering an additional pharmaceutical agent. In some aspects, the additional pharmaceutical agent is selected from the group consisting of a proton pump inhibitor, a histamine type 2 (H2) receptor antagonist, misoprostol, and combinations thereof. In some aspects, the proton pump inhibitor is omeprazole or esomeprazole. In some aspects, the H2-receptor antagonist is selected from the group consisting of ranitidine, nizatidine, cimetidine, famotidine, and combinations thereof.KITS

[0206] Any embodiment directed to a kit for weight loss, the kit including a pharmaceutical agent of any embodiment described herein, and a properly titrated composition, wherein the properly titrated composition is any composition described herein or in U.S. Patent Nos. 9,701,735, 10,611,828, and U.S. Patent No. 12,263,192, the disclosures of each of which are incorporated by reference in their entirety.

[0207] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition including a colostrum product.

[0208] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including an egg product.Attorney Docket No.: 148548-001102

[0209] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including a colostrum product and an egg product.

[0210] In some aspects, the techniques described herein relate to a kit, wherein the composition is administered orally.

[0211] In some aspects, the techniques described herein relate to a kit, wherein the properly titrated composition is one to fourteen single doses. In some aspects, the techniques described herein relate to a kit, wherein the properly titrated composition is a single dose.

[0212] In some aspects, the techniques described herein relate to a kit, wherein the single dose of the composition is about 1 g to about 28 g. In some aspects, the techniques described herein relate to a kit, wherein the single dose of the composition is about 7 g to about 14 g. In some aspects, the techniques described herein relate to a kit, wherein the single dose of the composition is about 7 g. In some aspects, the effective amount of the composition comprises from 1 g to 50 g, 4 g to 30 g, 5 g to 20 g, or 6 g to 15 g of combined weight of the egg product and the colostrum on a dry weight equivalent basis per dose.

[0213] In some aspects, the techniques described herein relate to a kit, wherein the composition further includes one or more additional active agents. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents is an H2 receptor blocker. In some aspects, the techniques described herein relate to a kit, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents is an antinausea medication. In some aspects, the techniques described herein relate to a kit, wherein the antinausea medication is ondansetron. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents is a prokinetic medication. In some aspects, the techniques described herein relate to a kit, wherein the prokinetic medication is metoclopramide. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents is an antimotility drug. In some aspects, the techniques described herein relate to a kit, wherein the one or more active agents is a nonabsorbable antibiotic. In some aspects, the techniques described herein relate to a kit, wherein the non-absorbable antibiotic is rifaximin.Attorney Docket No.: 148548-001102

[0214] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including a bovine colostrum.

[0215] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including an egg product; wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0216] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including an egg product and a bovine colostrum; wherein the egg product includes at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0217] Aspects described herein are directed to a kit for weight loss, the kit including: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof; and a properly titrated composition including an effective amount of an IgY antibody and a carrier matrix derived from bovine colostrum; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of the pharmaceutical agent.

[0218] In some aspects, the techniques described herein relate to a kit, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus,Attorney Docket No.: 148548-001102 coronavirus, pathogen-related toxins, pathogen-related adhesion elements, or combinations thereof.ADDITIONAL EMBODIMENTS

[0219] Clause 1. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of a colostrum product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0220] Clause 2. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0221] Clause 3. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of a colostrum product and an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co- agonist, and combinations thereof.

[0222] Clause 4. The method of clause 3, wherein the colostrum product is a bovine colostrum product.

[0223] Clause 5. The method of clause 3, wherein the colostrum product is a human colostrum product.

[0224] Clause 6. The method of clause 4, wherein the bovine colostrum product comprises subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.

[0225] Clause 7. The method of clause 6, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulins, casein, IgG, lactoferrin,Attorney Docket No.: 148548-001102 lactoperoxidase, a-lactalbumin, glycomacropeptide, P-lactoglobulin, growth factors, and combinations thereof.

[0226] Clause 8. The method of clause 6, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

[0227] Clause 9. The method of clause 6, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

[0228] Clause 10. The method of clause 6, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.

[0229] Clause 11. The method of clause 6, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

[0230] Clause 12. The method of clause 6, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid- stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

[0231] Clause 13. The method of clause 6, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocyte-macrophage colony-stimulating factor, and interleukin 1 [3, interleukin 6, interleukin 10, colostrinin / proline- rich polypeptide (PRP), and combinations thereof.

[0232] Clause 14. The method of clause 6, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulin-like growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor P, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

[0233] Clause 15. The method of clause 3, wherein the egg product is a whole egg.

[0234] Clause 16. The method of clause 3, wherein the egg product is a fowl egg.

[0235] Clause 17. The method of clause 3, wherein the egg product is a chicken egg.

[0236] Clause 18. The method of clause 3, wherein the egg product comprises subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

[0237] Clause 19. The method of clause 18, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin, ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.Attorney Docket No.: 148548-001102

[0238] Clause 20. The method of clause 18, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.

[0239] Clause 21. The method of clause 18, wherein the egg product is a vitamin, and the vitamin is selected from vitamin B12, vitamin D, riboflavin, choline, and combinations thereof.

[0240] Clause 22. The method of clause 18, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

[0241] Clause 23. The method of clause 18, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

[0242] Clause 24. The method of clause 18, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

[0243] Clause 25. The method of clause 18, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

[0244] Clause 26. The method of clause 18, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth facto r-[:S (TGF-[3), and combinations thereof.

[0245] Clause 27. The method of clause 3, wherein the egg product is an immune egg.

[0246] Clause 28. The method of clause 3, wherein the egg product is a hyperimmune egg-10247] Clause 29. The method of clause 3, wherein the egg product is a nonhyperimmune egg.

[0248] Clause 30. The method of clause 3, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 1:10 to about 10:1.

[0249] Clause 31. The method of clause 3, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 3:2.

[0250] Clause 32. The method of clause 3, wherein the subject is being treated with the pharmaceutical agent for diabetes or weight loss.

[0251] Clause 33. The method of clause 3, wherein the composition is used to manage the gastrointestinal side effects without use of additional pharmaceuticals for symptom relief.Attorney Docket No.: 148548-001102

[0252] Clause 34. The method of clause 3, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

[0253] Clause 35. The method of clause 3, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0254] Clause 36. The method of clause 3, wherein the composition is administered without requiring a dosage adjustment of the pharmaceutical agent.

[0255] Clause 37. The method of clause 3, wherein the composition is administered orally.

[0256] Clause 38. The method of clause 3, wherein the composition is used to manage gastrointestinal side effects without additional pharmaceuticals for symptom relief.

[0257] Clause 39. The method of clause 3, wherein the composition is administered at the same time as administration of the pharmaceutical agent.

[0258] Clause 40. The method of clause 3, wherein the composition is administered prior to administration of the pharmaceutical agent.

[0259] Clause 41. The method of clause 3, wherein the composition is administered subsequent to administration of the pharmaceutical agent.

[0260] Clause 42. The method of clause 3, wherein the composition is administered at regular intervals throughout a day.

[0261] Clause 43. The method of clause 3, wherein the composition is administered once per week.

[0262] Clause 44. The method of clause 3, wherein the composition is administered about once per week to about 7 times per week.

[0263] Clause 45. The method of clause 3, wherein the composition is administered as needed to manage gastrointestinal side effects.

[0264] Clause 46. The method of clause 3, wherein the composition is administered once per day.

[0265] Clause 47. The method of clause 3, wherein the composition is administered multiple times per day.

[0266] Clause 48. The method of clause 3, wherein the composition is administered twice per day.

[0267] Clause 49. The method of clause 3, wherein the composition is administered four twice per day.Attorney Docket No.: 148548-001102

[0268] Clause 50. The method of clause 3, wherein the composition is administered as a single dose.

[0269] Clause 51. The method of clause 50, wherein the single dose of the composition is about 7 g to about 14 g.

[0270] Clause 52. The method of clause 50, wherein the single dose of the composition is about 7 g.

[0271] Clause 53. The method of clause 3, wherein the composition is administered in a regimen adjusted based on a severity of the gastrointestinal side effects experienced by the subject.

[0272] Clause 54. The method of clause 3, wherein the composition further comprises one or more additional active agents.

[0273] Clause 55. The method of clauses 54, wherein the one or more additional active agents is an H2 receptor blocker.

[0274] Clause 56. The method of clause 55, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0275] Clause 57. The method of clause 54, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0276] Clause 58. The method of clause 54, wherein the one or more additional active agents is an antinausea medication.

[0277] Clause 59. The method of clause 58, wherein the antinausea medication is ondansetron.

[0278] Clause 60. The method of clause 54, wherein the one or more additional active agents is a prokinetic medication.

[0279] Clause 61. The method of clause 60, wherein the prokinetic medication is metoclopramide.

[0280] Clause 62. The method of clause 54, wherein the one or more additional active agents is an antimotility drug.

[0281] Clause 63. The method of clause 54, wherein the one or more additional active agents is a non-absorbable antibiotic.

[0282] Clause 64. The method of clause 63, wherein the non-absorbable antibiotic is rifaximin.

[0283] Clause 65. The method of clause 3, wherein the method further comprises administering one or more additional components selected from the group consisting of a vitamin, mineral, amino acid, antioxidants, and combinations thereof.Attorney Docket No.: 148548-001102

[0284] Clause 66. The method of clause 65, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof.

[0285] Clause 67. The method of clause 66, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg.

[0286] Clause 68. The method of clause 66, wherein the vitamin C is in an amount of about 15 mg to about 60 mg.

[0287] Clause 69. The method of clause 66, wherein the folic acid is in an amount of about 80 pg to about 600 pg.

[0288] Clause 70. The method of clause 65, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

[0289] Clause 71. The method of clause 70, wherein the iron is in an amount of about 0.5 mg to about 18 mg.

[0290] Clause 72. The method of clause 3, wherein the composition is administered daily.

[0291] Clause 73. The method of clause 3, wherein the composition further comprises a probiotic component comprising one or more live microorganisms.

[0292] Clause 74. The method of clause 3, wherein the composition further comprises a prebiotic component comprising one or more types of dietary fiber.

[0293] Clause 75. The method of clause 3, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0294] Clause 76. The method of clause 3, wherein the composition provides nutrients and immune factors that restore normal intestinal function.

[0295] Clause 77. The method of clause 3, wherein the composition is marketed as a food for special dietary use.

[0296] Clause 78. The method of clause 3, wherein the subject is an adult.

[0297] Clause 79. The method of clause 3, wherein the subject is a child.

[0298] Clause 80. The method of clause 3, wherein administering the composition reduces small intestinal bacterial overgrowth of the subject.

[0299] Clause 81. The method of clause 3, wherein administering the composition protects a gut from irritation by pancreatic enzymes and bile.

[0300] Clause 82. The method of clause 3, wherein the gastrointestinal side effects are a result of a small intestinal bacterial overgrowth (SIBO) of the subject.

[0301] Clause 83. The method of clause 82, wherein the SIBO is measured using hydrogen breath testing.Attorney Docket No.: 148548-001102

[0302] Clause 84. The method of clause 83, wherein the SIBO of the subject is >12ppm greater than a baseline or control measurement of SIBO after lactulose or the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge.

[0303] Clause 85. The method of clause 84, wherein the SIBO is measured by small intestine aspirate.

[0304] Clause 86. The method of clause 85, wherein the SIBO is measured by fluid culture.

[0305] Clause 87. The method of clause 86, wherein the SIBO is measured using methane breath testing.

[0306] Clause 88. The method of claim 3, wherein the NSAID is a COX -2 inhibitor.

[0307] Clause 89. The method of claim 88, wherein the COX-2 inhibitor is selected from the group consisting of celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, parecoxib, and combinations thereof.

[0308] Clause 90. The method of claim 3, wherein the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, celecoxib, ketoprofen, indomethacin, and combinations thereof.

[0309] Clause 91. The method of any one of claims 3 to 90, wherein the method treats or prevents a drug-induced injury.

[0310] Clause 92. The method of 91, wherein the drug-induced injury is selected from the group consisting of gastrointestinal bleeding, a bleeding ulcer, a gastrointestinal obstruction, a gastrointestinal perforation, gastrointestinal erosion, gastrointestinal tract mucosal injury, and combinations thereof.

[0311] Clause 93. The method of claim 88, further comprising administering an additional pharmaceutical agent.

[0312] Clause 94. The method of claim 93, wherein the additional pharmaceutical agent is selected from the group consisting of a proton pump inhibitor, a histamine type 2 (H2) receptor antagonist, misoprostol, and combinations thereof.

[0313] Clause 95. The method of claim 94, wherein the proton pump inhibitor is omeprazole or esomeprazole.

[0314] Clause 96. The method of claim 95, wherein the H2-receptor antagonist is selected from the group consisting of ranitidine, nizatidine, cimetidine, famotidine, and combinations thereof.

[0315] Clause 97. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-Attorney Docket No.: 148548-001102 inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising a colostrum product.

[0316] Clause 98. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising an egg product.

[0317] Clause 99. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising a colostrum product and an egg product.

[0318] Clause 100. The kit of clause 90, wherein the properly titrated composition is administered orally.

[0319] Clause 101. The kit of clause 90, wherein the properly titrated composition is one to fourteen single doses.

[0320] Clause 102. The kit of clause 90, wherein the properly titrated composition is a single dose.

[0321] Clause 103. The kit of clause 93, wherein the single dose of the properly titrated composition is about 7 g to about 14 g.

[0322] Clause 104. The kit of clause 93, wherein the single dose of the properly titrated composition is about 7 g.

[0323] Clause 105. The kit of clause 90, wherein the properly titrated composition further comprises one or more additional active agents.

[0324] Clause 106. The kit of clauses 96, wherein the one or more additional active agents is an H2 receptor blocker.

[0325] Clause 107. The kit of clause 97, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0326] Clause 108. The kit of clause 96, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0327] Clause 109. The kit of clause 96, wherein the one or more additional active agents is an antinausea medication.Attorney Docket No.: 148548-001102

[0328] Clause 110. The kit of clause 100, wherein the antinausea medication is ondansetron.

[0329] Clause 111. The kit of clause 96, wherein the one or more additional active agents is a prokinetic medication.

[0330] Clause 112. The kit of clause 102, wherein the prokinetic medication is metoclopramide.

[0331] Clause 113. The kit of clause 96, wherein the one or more additional active agents is an antimotility drug.

[0332] Clause 114. The kit of clause 96, wherein the one or more additional active agents is a non-absorbable antibiotic.

[0333] Clause 115. The kit of clause 105, wherein the non-absorbable antibiotic is rifaximin.

[0334] Clause 116. A composition comprising an effective amount of a colostrum product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0335] Clause 117. A composition comprising an effective amount of an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like pep tide - 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0336] Clause 118. A composition comprising an effective amount of a colostrum product and an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0337] Clause 119. The composition of clause 109, wherein the colostrum product is a bovine colostrum product.

[0338] Clause 120. The composition of clause 109, wherein the colostrum product is a human colostrum product.Attorney Docket No.: 148548-001102

[0339] Clause 121. The composition of clause 110, wherein the bovine colostrum product comprises subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.

[0340] Clause 122. The composition of clause 112, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulin, casein, IgG, lactoferrin, lactoperoxidase, a-lactalbumin, glycomacropeptide, [3-lactoglobulin, growth factor, and combinations thereof.

[0341] Clause 123. The composition of clause 112, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

[0342] Clause 124. The composition of clause 112, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

[0343] Clause 125. The composition of clause 112, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.

[0344] Clause 126. The composition of clause 112, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

[0345] Clause 127. The composition of clause 112, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

[0346] Clause 128. The composition of clause 112, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocytemacrophage colony-stimulating factor, and interleukin 1J3, interleukin 6, interleukin 10, colostrinin / proline-rich polypeptide (PRP), and combinations thereof.

[0347] Clause 129. The composition of clause 112, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulin-like growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor [3, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

[0348] Clause 130. The composition of clause 109, wherein the egg product is a whole egg-Attorney Docket No.: 148548-001102

[0349] Clause 131. The composition of clause 109, wherein the egg product is a fowl egg-10350] Clause 132. The composition of clause 109, wherein the egg product is a chicken egg.

[0351] Clause 133. The composition of clause 109, wherein the egg product comprises subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

[0352] Clause 134. The composition of clause 124, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin, ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.

[0353] Clause 135. The composition of clause 124, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.

[0354] Clause 136. The composition of clause 124, wherein the egg product is a vitamin, and the vitamin is selected from vitamin B12, vitamin D, riboflavin, choline, and combinations thereof.

[0355] Clause 137. The composition of clause 124, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

[0356] Clause 138. The composition of clause 124, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

[0357] Clause 139. The composition of clause 124, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

[0358] Clause 140. The composition of clause 124, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

[0359] Clause 141. The composition of clause 124, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth factor-[:S (TGF-P), and combinations thereof.

[0360] Clause 142. The composition of clause 109, wherein the egg product is an immune egg.Attorney Docket No.: 148548-001102

[0361] Clause 143. The composition of clause 109, wherein the egg product is a hyperimmune egg.

[0362] Clause 144. The composition of clause 109, wherein the egg product is a nonhyperimmune egg.

[0363] Clause 145. A method of treating gastrointestinal side effects of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition comprising a bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0364] Clause 146. A method of treating gastrointestinal side effects of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition comprising an egg product, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP- 1 receptor co-agonist, and combinations thereof; and wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxin, pathogen related adhesion element, or combinations thereof.

[0365] Clause 147. A method of treating gastrointestinal side effects of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition comprising an egg product and a bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxin, pathogen related adhesion element, or combinations thereof.

[0366] Clause 148. The method of clause 138, wherein the at least one avian antibody or antigen binding fragment thereof, is specific for a pathogenic component from one, two, three, four, five, six, seven, or eight of different pathogenic microorganisms.

[0367] Clause 149. The method of clause 138, wherein the pathogen related toxin comprises an endotoxin or exotoxin.Attorney Docket No.: 148548-001102

[0368] Clause 150. The method of clause 138, wherein the pathogen related adhesion element comprises one or more adhesins, cadherins, cilia, fimbrillae, or viral adhesin structures.

[0369] Clause 151. The method of clause 138, wherein the bovine colostrum is whole bovine colostrum.

[0370] Clause 152. The method of clause 138, wherein the bovine colostrum is whole non-hyperimmune bovine colostrum.

[0371] Clause 153. The method of clause 138, wherein the egg product is a whole egg.

[0372] Clause 154. The method of clause 144, wherein the whole egg is a pasteurized raw dried whole egg powder.

[0373] Clause 155. The method of clause 138, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1:10 to about 10: 1.

[0374] Clause 156. The method of clause 146, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 3:2.

[0375] Clause 157. The method of clause 138, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1 : 10 to about 10:1 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

[0376] Clause 158. The method of clause 148, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 3:2 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

[0377] Clause 159. The method of clause 138, wherein the subject is treated and one or more changes are induced, wherein the one or more changes are selected from the group consisting of decreased enteric inflammation, change in intestinal microbiome, decreased blunting of intestinal villi, increased intestinal integrity, decreased ulceration, decreased leakage of intestinal contents, decreased systemic inflammation, increased weight-for-age z-score, increased height-for-age z-score, increased weight-for-height z-score, increased mid-upper arm circumference, change in antigen-specific antibody titer in the subject, reduction of abdominal pain, increase in physician-assessed well-being of the subject, decreased abnormal flattening of villi, decreased inflammation of a lining of small intestine, and decreased presence of inflammatory cells in biopsy of small intestine tissue, or a combination thereof.

[0378] Clause 160. The method of clause 138, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 1:10 to about 10:1.Attorney Docket No.: 148548-001102

[0379] Clause 161. The method of clause 138, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 3:2.

[0380] Clause 162. The method of clause 138, wherein the subject is being treated with the pharmaceutical agent for diabetes or weight loss.

[0381] Clause 163. The method of clause 138, wherein the composition is used to manage the gastrointestinal side effects without use of additional pharmaceuticals for symptom relief.

[0382] Clause 164. The method of clause 138, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

[0383] Clause 165. The method of clause 138, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0384] Clause 166. The method of clause 138, wherein the composition is administered without requiring a dosage adjustment of the pharmaceutical agent.

[0385] Clause 167. The method of clause 138, wherein the composition is administered orally.

[0386] Clause 168. The method of clause 138, wherein the composition is used to manage gastrointestinal side effects without additional pharmaceuticals for symptom relief.

[0387] Clause 169. The method of clause 138, wherein the composition IS administered at the same time as administration of the pharmaceutical agent.

[0388] Clause 170. The method of clause 138, wherein the composition IS administered prior to administration of the pharmaceutical agent.

[0389] Clause 171. The method of clause 138, wherein the composition is administered subsequent to administration of the pharmaceutical agent.

[0390] Clause 172. The method of clause 138, wherein the composition is administered at regular intervals throughout a day.

[0391] Clause 173. The method of clause 138, wherein the composition is administered once per week.

[0392] Clause 174. The method of clause 138, wherein the composition is administered about once per week to about 7 times per week.

[0393] Clause 175. The method of clause 138, wherein the composition is administered as needed to manage gastrointestinal side effects.

[0394] Clause 176. The method of clause 138, wherein the composition is administered once per day.Attorney Docket No.: 148548-001102

[0395] Clause 177. The method of clause 138, wherein the composition is administered multiple times per day.

[0396] Clause 178. The method of clause 138, wherein the composition is administered twice per day.

[0397] Clause 179. The method of clause 138, wherein the composition is administered four twice per day.

[0398] Clause 180. The method of clause 138, wherein the composition is administered as a single dose.

[0399] Clause 181. The method of clause 171, wherein the single dose of the composition is about 7 g to about 14 g.

[0400] Clause 182. The method of clause 171, wherein the single dose of the composition is about 7 g.

[0401] Clause 183. The method of clause 138, wherein the composition is administered in a regimen adjusted based on a severity of the gastrointestinal side effects experienced by the subject.

[0402] Clause 184. The method of clause 138, wherein the composition further comprises one or more additional active agents.

[0403] Clause 185. The method of clauses 175, wherein the one or more additional active agents is an H2 receptor blocker.

[0404] Clause 186. The method of clause 176, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0405] Clause 187. The method of clause 175, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0406] Clause 188. The method of clause 175, wherein the one or more additional active agents is an antinausea medication.

[0407] Clause 189. The method of clause 179, wherein the antinausea medication is ondansetron.

[0408] Clause 190. The method of clause 175, wherein the one or more additional active agents is a prokinetic medication.

[0409] Clause 191. The method of clause 181, wherein the prokinetic medication is metoclopramide.

[0410] Clause 192. The method of clause 175, wherein the one or more additional active agents is an antimotility drug.Attorney Docket No.: 148548-001102

[0411] Clause 193. The method of clause 175, wherein the one or more additional active agents is a non-absorbable antibiotic.

[0412] Clause 194. The method of clause 184, wherein the non-absorbable antibiotic is rifaximin.

[0413] Clause 195. The method of clause 138, wherein the method further comprises administering one or more additional components selected from the group consisting of a vitamin, mineral, amino acid, antioxidants, and combinations thereof.

[0414] Clause 196. The method of clause 186, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof.

[0415] Clause 197. The method of clause 187, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg.

[0416] Clause 198. The method of clause 187, wherein the vitamin C is in an amount of about 15 mg to about 60 mg.

[0417] Clause 199. The method of clause 187, wherein the folic acid is in an amount of about 80 pg to about 600 pg.

[0418] Clause 200. The method of clause 186, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

[0419] Clause 201. The method of clause 191, wherein the iron is in an amount of about 0.5 mg to about 18 mg.

[0420] Clause 202. The method of clause 138, wherein the composition is administered daily.

[0421] Clause 203. The method of clause 138, wherein the composition further comprises a probiotic component comprising one or more live microorganisms.

[0422] Clause 204. The method of clause 138, wherein the composition further comprises a prebiotic component comprising one or more types of dietary fiber.

[0423] Clause 205. The method of clause 138, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0424] Clause 206. The method of clause 138, wherein the composition provides nutrients and immune factors that restore normal intestinal function.

[0425] Clause 207. The method of clause 138, wherein the composition is marketed as a food for special dietary use.

[0426] Clause 208. The method of clause 138, wherein the subject is an adult.

[0427] Clause 209. The method of clause 138, wherein the subject is a child.

[0428] Clause 210. The method of clause 138, wherein administering the composition reduces small intestinal bacterial overgrowth of the subject.Attorney Docket No.: 148548-001102

[0429] Clause 211. The method of clause 138, wherein administering the composition protects a gut from irritation by pancreatic enzymes and bile.

[0430] Clause 212. The method of clause 138, wherein the gastrointestinal side effects are a result of a small intestinal bacterial overgrowth (SIBO) of the subject.

[0431] Clause 213. The method of clause 203, wherein the SIBO is measured using hydrogen breath testing.

[0432] Clause 214. The method of clause 204, wherein the SIBO of the subject is >12ppm greater than a baseline or control measurement of SIBO after lactulose or the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge.

[0433] Clause 215. The method of clause 205, wherein the SIBO is measured by small intestine aspirate.

[0434] Clause 216. The method of clause 206, wherein the SIBO is measured by fluid culture.

[0435] Clause 217. The method of clause 207, wherein the SIBO is measured using methane breath testing.

[0436] Clause 218. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising a bovine colostrum.

[0437] Clause 219. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising an egg product; wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0438] Clause 220. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising an egg product and a bovineAttorney Docket No.: 148548-001102 colostrum; wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0439] Clause 221. The kit of clause 211, wherein the properly titrated composition is administered orally.

[0440] Clause 222. The kit of clause 211, wherein the properly titrated composition is one to fourteen single doses.

[0441] Clause 223. The kit of clause 211, wherein the properly titrated composition is a single dose.

[0442] Clause 224. The kit of clause 214, wherein the single dose of the properly titrated composition is about 7 g to about 14 g.

[0443] Clause 225. The kit of clause 214, wherein the single dose of the properly titrated composition is about 7 g.

[0444] Clause 226. The kit of clause 211, wherein the properly titrated composition further comprises one or more additional active agents.

[0445] Clause 227. The kit of clauses 217, wherein the one or more additional active agents is an H2 receptor blocker.

[0446] Clause 228. The kit of clause 218, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0447] Clause 229. The kit of clause 217, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0448] Clause 230. The kit of clause 217, wherein the one or more additional active agents is an antinausea medication.

[0449] Clause 231. The kit of clause 221, wherein the antinausea medication is ondansetron.

[0450] Clause 232. The kit of clause 217, wherein the one or more additional active agents is a prokinetic medication.

[0451] Clause 233. The kit of clause 223, wherein the prokinetic medication is metoclopramide.

[0452] Clause 234. The kit of clause 217, wherein the one or more additional active agents is an antimotility drug.

[0453] Clause 235. The kit of clause 217, wherein the one or more additional active agents is a non-absorbable antibiotic.Attorney Docket No.: 148548-001102

[0454] Clause 236. The kit of clause 226, wherein the non-absorbable antibiotic is rifaximin.

[0455] Clause 237. A composition comprising an effective amount of a bovine colostrum, wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0456] Clause 238. A composition comprising an effective amount of an egg product, wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

[0457] Clause 239. A composition comprising an effective amount of an egg product and a bovine colostrum, wherein the egg product comprises at least one avian antibody or antigen binding fragment thereof, that specifically binds to Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, a pathogen related toxin, a pathogen related adhesion element, or combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of a pharmaceutical agent wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co- agonist, and combinations thereof.

[0458] Clause 240. The composition of clause 230, wherein the at least one avian antibody, or antigen binding fragment thereof, is specific for a pathogenic component from one, two, three, four, five, six, seven, or eight of different pathogenic microorganisms.

[0459] Clause 241. The composition of clause 230, wherein the pathogen-related toxin comprises an endotoxin or exotoxin.Attorney Docket No.: 148548-001102

[0460] Clause 242. The composition of clause 230, wherein the pathogen-related adhesion element comprises one or more adhesins, cadherins, cilia, fimbrillae, or viral adhesin structures.

[0461] Clause 243. The composition of clause 230, wherein the bovine colostrum is whole bovine colostrum.

[0462] Clause 244. The composition of clause 230, wherein the bovine colostrum is whole non-hyperimmune bovine colostrum.

[0463] Clause 245. The composition of clause 230, wherein the egg product is a whole egg-10464] Clause 246. The composition of clause 236, wherein the whole egg is a pasteurized raw dried whole egg powder.

[0465] Clause 247. The composition of clause 230, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1:10 to about 10:1.

[0466] Clause 248. The composition of clause 238, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis of about 3:2.

[0467] Clause 249. The composition of clause 230, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 1:10 to about 10:1 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

[0468] Clause 250. The composition of clause 240, wherein the composition has a weight ratio of bovine colostrum to immune egg antibody product, on a dry weight equivalent basis, of about 3:2 of a combined weight of the immune egg antibody product and the bovine colostrum on a dry weight equivalent basis per dose.

[0469] Clause 251. A method for treating gastrointestinal side effects of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of a mixture of IgY antibody and a carrier matrix derived from bovine colostrum, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and wherein the effective amount of the composition is effective to treat gastrointestinal side effects of the pharmaceutical agent.

[0470] Clause 252. The method of clause 242, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus,Attorney Docket No.: 148548-001102Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0471] Clause 253. The method of clause 242, wherein the IgY antibody is present in a concentration effective to neutralize pathogens, toxins, or adhesion elements in a gastrointestinal tract.

[0472] Clause 254. The method of clause 242, wherein the carrier matrix further comprises one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants.

[0473] Clause 255. The method of clause 242, wherein the carrier matrix is formulated to protect the IgY antibody from degradation in a stomach and to facilitate release of at least one specific binding molecule in an intestine.

[0474] Clause 256. The method of clause 242, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0475] Clause 257. The method of clause 242, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 1:10 to about 10:1.

[0476] Clause 258. The method of clause 242, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 3:2.

[0477] Clause 259. The method of clause 242, wherein the subject is being treated with the pharmaceutical agent for diabetes or weight loss.

[0478] Clause 260. The method of clause 242, wherein the composition is used to manage the gastrointestinal side effects without use of additional pharmaceuticals for symptom relief.

[0479] Clause 261. The method of clause 242, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

[0480] Clause 262. The method of clause 242, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0481] Clause 263. The method of clause 242, wherein the composition is administered without requiring a dosage adjustment of the pharmaceutical agent.

[0482] Clause 264. The method of clause 242, wherein the composition is administered orally.

[0483] Clause 265. The method of clause 242, wherein the composition is used to manage gastrointestinal side effects without additional pharmaceuticals for symptom relief.Attorney Docket No.: 148548-001102

[0484] Clause 266. The method of clause 242, wherein the composition is administered at the same time as administration of the pharmaceutical agent.

[0485] Clause 267. The method of clause 242, wherein the composition is administered prior to administration of the pharmaceutical agent.

[0486] Clause 268. The method of clause 242, wherein the composition is administered subsequent to administration of the pharmaceutical agent.

[0487] Clause 269. The method of clause 242, wherein the composition is administered at regular intervals throughout a day.

[0488] Clause 270. The method of clause 242, wherein the composition is administered once per week.

[0489] Clause 271. The method of clause 242, wherein the composition is administered about once per week to about 7 times per week.

[0490] Clause 272. The method of clause 242, wherein the composition is administered as needed to manage gastrointestinal side effects.

[0491] Clause 273. The method of clause 242, wherein the composition is administered once per day.

[0492] Clause 274. The method of clause 242, wherein the composition is administered multiple times per day.

[0493] Clause 275. The method of clause 242, wherein the composition is administered twice per day.

[0494] Clause 276. The method of clause 242, wherein the composition is administered four twice per day.

[0495] Clause 277. The method of clause 242, wherein the composition is administered as a single dose.

[0496] Clause 278. The method of clause 268, wherein the single dose of the composition is about 7 g to about 14 g.

[0497] Clause 279. The method of clause 268, wherein the single dose of the composition is about 7 g.

[0498] Clause 280. The method of clause 242, wherein the composition is administered in a regimen adjusted based on a severity of the gastrointestinal side effects experienced by the subject.

[0499] Clause 281. The method of clause 242, wherein the composition further comprises one or more additional active agents.

[0500] Clause 282. The method of clauses 272, wherein the one or more additional active agents is an H2 receptor blocker.Attorney Docket No.: 148548-001102

[0501] Clause 283. The method of clause 273, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0502] Clause 284. The method of clause 272, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0503] Clause 285. The method of clause 272, wherein the one or more additional active agents is an antinausea medication.

[0504] Clause 286. The method of clause 276, wherein the antinausea medication is ondansetron.

[0505] Clause 287. The method of clause 272, wherein the one or more additional active agents is a prokinetic medication.

[0506] Clause 288. The method of clause 278, wherein the prokinetic medication is metoclopramide.

[0507] Clause 289. The method of clause 272, wherein the one or more additional active agents is an antimotility drug.

[0508] Clause 290. The method of clause 272, wherein the one or more additional active agents is a non-absorbable antibiotic.

[0509] Clause 291. The method of clause 281, wherein the non-absorbable antibiotic is rifaximin.

[0510] Clause 292. The method of clause 242, wherein the method further comprises administering one or more additional components selected from the group consisting of a vitamin, mineral, amino acid, antioxidant, and combinations thereof.

[0511] Clause 293. The method of clause 283, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof.

[0512] Clause 294. The method of clause 284, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg.

[0513] Clause 295. The method of clause 284, wherein the vitamin C is in an amount of about 15 mg to about 60 mg.

[0514] Clause 296. The method of clause 284, wherein the folic acid is in an amount of about 80 pg to about 600 pg.

[0515] Clause 297. The method of clause 283, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

[0516] Clause 298. The method of clause 288, wherein the iron is in an amount of about 0.5 mg to about 18 mg.Attorney Docket No.: 148548-001102

[0517] Clause 299. The method of clause 242, wherein the composition is administered daily.

[0518] Clause 300. The method of clause 242, wherein the composition further comprises a probiotic component comprising one or more live microorganisms.

[0519] Clause 301. The method of clause 242, wherein the composition further comprises a prebiotic component comprising one or more types of dietary fiber.

[0520] Clause 302. The method of clause 242, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0521] Clause 303. The method of clause 242, wherein the composition provides nutrients and immune factors that restore normal intestinal function.

[0522] Clause 304. The method of clause 242, wherein the composition is marketed as a food for special dietary use.

[0523] Clause 305. The method of clause 242, wherein the subject is an adult.

[0524] Clause 306. The method of clause 242, wherein the subject is a child.

[0525] Clause 307. The method of clause 242, wherein administering the composition reduces small intestinal bacterial overgrowth of the subject.

[0526] Clause 308. The method of clause 242, wherein administering the composition protects a gut from irritation by pancreatic enzymes and bile.

[0527] Clause 309. The method of clause 242, wherein the gastrointestinal side effects are a result of a small intestinal bacterial overgrowth (SIBO) of the subject.

[0528] Clause 310. The method of clause 300, wherein the SIBO is measured using hydrogen breath testing.

[0529] Clause 311. The method of clause 301, wherein the SIBO of the subject is >12ppm greater than a baseline or control measurement of SIBO after lactulose or the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge.

[0530] Clause 312. The method of clause 302, wherein the SIBO is measured by small intestine aspirate.

[0531] Clause 313. The method of clause 303, wherein the SIBO is measured by fluid culture.

[0532] Clause 314. The method of clause 304, wherein the SIBO is measured using methane breath testing.

[0533] Clause 315. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal antiinflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastricAttorney Docket No.: 148548-001102 inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising an effective amount of an IgY antibody and a carrier matrix derived from bovine colostrum; wherein the effective amount of the properly titrated composition is effective to treat gastrointestinal side effects of the pharmaceutical agent.

[0534] Clause 316. The kit of clause 306, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen-related toxins, pathogen-related adhesion elements, or combinations thereof.

[0535] Clause 317. The kit of clause 307, wherein the properly titrated composition is administered orally.

[0536] Clause 318. The kit of clause 307, wherein the properly titrated composition is one to fourteen single doses.

[0537] Clause 319. The kit of clause 307, wherein the properly titrated composition is a single dose.

[0538] Clause 320. The kit of clause 310, wherein the single dose of the properly titrated composition is about 7 g to about 14 g.

[0539] Clause 321. The kit of clause 310, wherein the single dose of the properly titrated composition is about 7 g.

[0540] Clause 322. The kit of clause 307, wherein the properly titrated composition further comprises one or more additional active agents.

[0541] Clause 323. The kit of clauses 313, wherein the one or more additional active agents is an H2 receptor blocker.

[0542] Clause 324. The kit of clause 314, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

[0543] Clause 325. The kit of clause 313, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

[0544] Clause 326. The kit of clause 313, wherein the one or more additional active agents is an antinausea medication.

[0545] Clause 327. The kit of clause 317, wherein the antinausea medication is ondansetron.

[0546] Clause 328. The kit of clause 313, wherein the one or more additional active agents is a prokinetic medication.Attorney Docket No.: 148548-001102

[0547] Clause 329. The kit of clause 319, wherein the prokinetic medication is metoclopramide.

[0548] Clause 330. The kit of clause 313, wherein the one or more additional active agents is an antimotility drug.

[0549] Clause 331. The kit of clause 313, wherein the one or more additional active agents is a non-absorbable antibiotic.

[0550] Clause 332. The kit of clause 322, wherein the non-absorbable antibiotic is rifaximin.

[0551] Clause 333. A composition comprising an effective amount of a mixture of an IgY antibody and a carrier matrix derived from bovine colostrum; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor coagonist, and combinations thereof.

[0552] Clause 334. The composition of clause 324, wherein the IgY antibody is specific for antigens derived from the group selected from Escherichia coli, Streptococcus, Staphylococcus, Bacteroides, Klebsiella, Enterococcus, Proteus, rotavirus, coronavirus, pathogen related toxins, pathogen related adhesion elements, or combinations thereof.

[0553] Clause 335 The composition of clause 324, wherein the IgY antibody is present in a concentration effective to neutralize pathogens, toxins, or adhesion elements in a gastrointestinal tract.

[0554] Clause 336. The composition of clause 324, wherein the carrier matrix further comprises one or more additional components selected from the group consisting of vitamins, minerals, amino acids, and antioxidants.

[0555] Clause 337. The composition of clause 324, wherein the carrier matrix is formulated to protect the IgY antibody from degradation in a stomach and to facilitate release of at least one specific binding molecule in an intestine.

[0556] Clause 338. The composition of clause 324, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

[0557] Clause 339. The composition of clause 324, wherein the composition further comprises a probiotic component comprising one or more live microorganisms.

[0558] Clause 340. The composition of clause 324, wherein the composition further comprises a prebiotic component comprising one or more types of dietary fiber.Attorney Docket No.: 148548-001102

[0559] Clause 341. The composition of clause 324, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

[0560] Clause 342. The composition of clause 324, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

[0561] The subject matter is now described with reference to the following examples. These examples are provided for the purpose of illustration only and the claims should in no way be construed as being limited to these examples, but rather should be construed to encompass any and all variations which become evident as a result of the teaching provided herein. Those of skill in the art will readily recognize a variety of non-critical parameters that could be changed or modified to yield essentially similar results.EXAMPLES

[0562] The disclosures of each and every patent, patent application, publication, and accession number cited herein are hereby incorporated herein by reference in their entirety.

[0563] While the present disclosure has been disclosed with reference to various embodiments, it is apparent that other embodiments and variations of these may be devised by others skilled in the art without departing from the true spirit and scope of the disclosure. The appended claims are intended to be construed to include all such embodiments and equivalent variations.Example 1: Effects of chicken egg powder, bovine colostrum, and combination therapy for treatment of gastrointestinal disorders

[0564] Abstract: Chicken egg and bovine colostrum (BC, milk produced for the first few days following birth) are rich in immunoglobulins, antimicrobial peptides, growth factors, and macro- and micro-nutrients. There is increasing interest in the value of natural-based products by the pharmaceutical industry as potential sources of novel medicinal compounds and by consumers / patients as standalone therapy to prevent or treat ill health or as an adjunct to western medicines, in the hope of either enhancing their efficacy or in reducing the side effects of the pharmaceutical drug. In vitro, in vivo, and clinical studies have shown therapeutic benefits for both components given alone and in combination. The combination of egg + BC has been shown to have synergistic effects on growth, repair, and gut protection, including microbiome-induced damage. This article describes the main constituents of egg and BC, studies of their use alone and in combination for a wide range of conditions, highlights areas requiring further research andAttorney Docket No.: 148548-001102 novel indications, such as GLP-1 -associated gut symptoms, where combination therapy may have particular appeal.

[0565] 1. Introduction: Medicinal products derived from nature have been used for thousands of years for a wide range of ailments. While many have been replaced by conventional Western pharmaceuticals, there is renewed interest in using natural-based products by the public, constituting a global, multi-million-dollar industry. Importantly, the distinction between the use of natural-based products and pharmacological medicine is becoming blurred; the pharmaceutical industry examines natural products for sources of novel medicinal compounds, and patients may be taking natural-based products in addition to western medicines, in the hope of either enhancing their efficacy or in reducing the side effects of the pharmaceutical drugs. However, it is noteworthy that the major market in natural-based products is with the intention of preventing as opposed to treating disease, and are often used for prolonged periods. Product safety is, therefore, of particular importance.

[0566] Natural products with pharmaceutical activity are sometimes termed nutraceuticals (from nutrition and pharmaceuticals). Two nutraceutical products which have potential value for the treatment of a wide range of conditions, including gastroenterological, are chicken egg and bovine colostrum (BC), used individually or together. These products distinguish themselves for particular attention as they are both natural-based, originate from normal food products and have GRAS (generally regarded as safe) status in the USA. In addition, in contrast to many other products marketed by the health supplement industry, there is a strong science publication base demonstrating their effects in a wide range of in vitro and in vivo situations, including clinical trials. This review provides A. an overview of the constituents of chicken egg and bovine colostrum, B. studies of their use alone and in combination for a wide range of conditions, including evidence for synergistic activity of the combination and C. highlights areas for further research.

[0567] 2. Constituents of chicken egg powder: Eggs are considered nutrient-rich foods containing high levels of macro and micronutrients.

[0568] 2.1 Macronutrients and Micronutrients

[0569] 2.1.1 Proteins: Egg proteins are equally distributed between egg yolk and white, constituting about 13% of egg total weight, along with 10% fat but with minimal carbohydrate (<1%). Hundreds of different proteins have been identified within an egg, the most abundant being ovalbumin, accounting for about 54% of total protein, with the remaining major constituents comprising ovotransferrin (12%), ovomucoid (11%), ovoglobulin (8%), ovomucin (3.5%), and lysozyme (3%). Within the yolk, albumin, ovalbumin, immunoglobulinsAttorney Docket No.: 148548-001102 apolipoprotein B, apovitellenin-1, vitellogenins, and ovotransferrin are the most abundant proteins.

[0570] 2.1.2 Fats & lipids: Total lipid content is approximately 10g per 100g of whole egg and is mainly concentrated in the egg yolk. Y oik is rich in essential fatty acids such as linoleic acid (FA 18:2 9c, 12c (n-6)) and is relatively high in cholesterol (400mg per 100g of whole egg).

[0571] 2.1.3 Vitamins & Minerals: Egg is a rich source of Vitamins B12, D, riboflavin and choline, the minerals phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, and manganese.

[0572] 2.2 Bioactive Components: Egg powder contains multiple components that influence development, growth, immunity, and repair. Some of the major components are briefly discussed below.

[0573] 2.2.1 Antimicrobial Factors: The main form of Ig in eggs is IgY, which has functional resemblance to mammalian IgG with two heavy chains and two light chains. It differs from IgG by not combining with human Fc receptors or complement and does not possess a hinge region. The relative advantage of IgY versus IgG is dependent on the clinical situation, but some potential advantages of IgY over IgG include greater specificity due to the lack of hinge region and the ability to neutralize pathogens without inducing an excessive inflammatory response, due to not binding complement.

[0574] In addition to IgY, several other components of egg exhibit antimicrobial activity against bacteria, parasite and fungi. Some peptides / protein act through permeabilizing bacterial cell walls, e.g., lysozyme, avian beta defensins, while others act through decreasing bioavailability of iron (ovotransferrin), vitamins (avidin), or through inhibition of bacterial proteases (ovoinhibitor, cystatin). Proteolytic digestion of ovalbumin by trypsin or chymotrypsin has also been shown to produce peptide fragments with bactericidal activity.

[0575] 2.2.2 Cytokines: In addition to its anti-bacterial activity, lysozyme may function as an anti-inflammatory cytokine. Additional immunomodulatory peptides within eggs include egg-white pleiotrophin and sulfated glycoproteins generated by proteolysis from ovomucin, chalazae and yolk membrane.

[0576] 2.2.3 Growth Factors: Both raw and pasteurized egg powder exhibit pro- proliferative and pro-migratory bioactivity against a variety of cell lines. Studies regarding which factors are most relevant in inducing these effects are less progressed than with BC. Pro- proliferative and migratory activity against human gastrointestinal cell lines has been found in both yolk and egg white components, with ovomucoid and ovalbumin being the major likely contributors. Interestingly, much of the pro-proliferative activity could be prevented by the copresence of a tryphostin epidermal growth factor (EGF) receptor blocker, even though neitherAttorney Docket No.: 148548-001102 ovomucoid nor ovalbumin is thought to be a direct receptor ligand. The promigratory effect of egg was also inhibited by the addition of a transforming growth factor-fl (TGF-P) -blocking antibody. Many other peptides with growth factor / cytokine activity have been shown to elicit similar effects in various cell lines, a phenomenon thought to be due to increasing the local production of transforming growth factor [:S, with TGF[:S acting as an intermediary signaler.

[0577] 3. Constituents of BC: Although the constituents of BC and mature bovine milk are similar, the relative concentration of macronutrients and bioactive molecules is markedly different. The major constituents, including bioactive factors, are briefly discussed below.

[0578] 3.1 Macronutrients and Micronutrients

[0579] 3.1.1 Proteins and Peptides: BC contains higher total protein, immunoglobulins and casein content compared to mature milk. Whey and casein comprise the soluble and insoluble proteins respectively, with both contributing to the nutritional and bioactivity properties. For example, casein contains peptides with opioid-type and immune modulatory activity and, along with bovine trypsin inhibitor, probably contributes to the preservation of bioactivity and facilitating adsorption of bioactive peptides / proteins, through reducing digestion from pancreatic proteolytic enzymes. Therefore, in addition to being a source of energy, it also contributes to antimicrobial, immunological and, and anti-inflammatory activity. Whey protein contains multiple bioactive components including IgG, lactoferrin, lactoperoxidase, a-lactalbumin, glycomacropeptide, [S-lactoglobulin, and growth factors. It is also relevant that partial hydrolysates of whey and casein may influence innate immunity, acting through toll-like receptors.

[0580] 3.1.2 Carbohydrates: BC contains many carbohydrates in the forms of lactose, glycoprotein, glycolipid, nucleotide sugars. Oligosaccharides are present at about twice the concentration of that found in mature milk, and along with glycosylated proteins, may act as prebiotics through being substrates for colonic bacteria.

[0581] 3.1.3 Fats and Lipids: The fat content of BC mainly resides within milk fat globules. Amongst these constituents, gangliosides and phospholipids are polar lipids involved in multiple functions such as neuronal development, binding of pathogens, and immune activation.

[0582] 3.1.4 Vitamins and Minerals: BC contains water-soluble and fat-soluble vitamins, usually at higher levels than mature milk, in addition to being rich in calcium, iron, zinc, magnesium, manganese, copper and phosphorus.

[0583] 3.2 Bioactive Components

[0584] 3.2.1 Bioactive components within BC affect multiple physiological pathways including those relating to growth, development, and immunity. Some of the major components are briefly discussed below.Attorney Docket No.: 148548-001102

[0585] 3.2.2 Antimicrobial Factors: BC is rich in immunoglobulins, mainly in the form of IgG. The maternal cow is exposed to a wide range of pathogens naturally and develops specific IgG’s against them. These are passed intact into the bloodstream of the suckling calf, and it is therefore important to note that this is distinct to the human situation of ingesting BC, where any immunological effects caused are not due to the IgG entering the bloodstream intact, as they are probably digested within the gut lumen. Nevertheless, IgG within BC immunoglobulins may still be involved in preventing the binding of microbes to host cells, facilitating pathogen presentation to macrophages, stimulating B and T cell activation, and changing gut microflora. Several other components of BC also possess antimicrobial activity. These include lysozyme, lactoperoxidase, and lactoferrin, which are damaging to both gram-positive and gram-negative bacteria. Lactoferrin has many functions, including increasing iron absorption, and may have value for the prevention of necrotizing enterocolitis in premature babies.

[0586] 3.2.3 Cytokines: Cytokines are peptides or proteins that influence immune activation, cell signaling, and recognition of pathogens. Cytokine content within BC includes tumor necrosis factor-a, granulocyte-macrophage colony-stimulating factor, and interleukins (IL)- ip, -6, and -10. Growth factors and cytokines are usually considered separately. However, the same molecules may show activity within both categories, such as influencing immunity and stimulating cell growth / repair. BC also contains Colostrinin / proline-rich polypeptide (PRP), which is a mixture of proline-rich polypeptides that helps moderate inflammatory responses.

[0587] 3.2.4 Growth Factors: In addition to the small molecules that affect growth and are sometimes referred to as preferred substrates, e.g., glutamine, nucleotides, and polyamines, there are the more classical growth factor peptides and proteins which act via receptor binding and cell signaling and influence growth, differentiation, and development. These include insulinlike growth factors (Somatomedins), and the EGF receptor ligand family that all bind the EGF (c- erbl) receptor. Members of this family include EGF, TGFa, and betacellulin. BC also contains members of the TGF[:I family, which may play a role in repair but paradoxically often reduces proliferation in cell culture assays. BC also contains bovine colostral growth factor (which has strong sequence homology with platelet-derived growth factor) and vascular endothelial growth factor which, as the name suggests, possesses angiogenic activity and may be relevant for increasing local blood supply in conditions such as gastric ulcer.

[0588] 3.2.5 Hormones: Hormones with BC include prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone and estrogen. However, the relevance of peptide hormones for adults ingesting BC is unclear as it is likely that virtually all are digested to inactive forms and does not enter the circulation intact.Attorney Docket No.: 148548-001102

[0589] 4. Studies of potential clinical benefit

[0590] 4.1 Egg alone: A major focus on the nutraceutical potential of egg protein relates to the antimicrobial activity of IgY against a wide range of microbes. An appealing aspect of using polyclonal IgY is in reducing the risk of developing microbial resistance. Immunization of chickens against a specific pathogen results in hyperimmune IgY, which has shown benefit for conditions such as rotavirus infection and potential for other conditions such as dental caries, influenza, and acne. Further discussion of hyperimmunized IgY goes beyond this review. However, it is important to note that “natural” non-immunized egg powder also possesses antimicrobial activity against a wide range of pathogens. For example, using human gut monolayer models, egg powder from non-immunized hens / egg powder was shown to provide protective activity against a broad spectrum of gut-relevant bacteria microbes, including E. coli, Klebsiella, and Pseudomonas. It is, however, uncertain how much of this activity was mediated through IgY versus the anti-microbial effects of lysozyme, avidin, beta defensins, and ovotransferrin, as well as partially digested peptide fragments exhibiting antimicrobial activity, as discussed earlier.

[0591] Additional areas where egg proteins may have therapeutic value include the macro- and micro-nutrient content of eggs and egg protein for maintaining skeletal muscle health / reducing sarcopenia and in acting as antioxidants; for example, a porcine model showed that administration of egg yolk proteins increased GSH and y-glutamyl cysteine synthetase mRNA expression in the gut wall and circulating red cells.

[0592] Other potential applications for egg-derived products include anti-cancer and anti-hypertensive activity, although the current evidence is limited; for example, lysozymes possesses tumor inhibitory activity, probably due to immunopotentiation. Several other egg proteins / peptides have been shown to induce apoptosis in cancer cells, protect against DNA damage, decrease invasive activity, and show cytotoxic and antimutagenic activity against a wide variety of cancer cell lines. Egg peptides / proteins that have been reported to influence blood pressure, mainly through the renin-angiotensin-aldosterone axis, include ovotransferrin and protein hydrolysates, especially tripeptide derivatives.

[0593] 4.2 BC alone: Most bioactive molecules within BC, including IgG, will be digested by acid and digestive enzymes and therefore not absorbed into the bloodstream intact. Disorders of the gastrointestinal tract are, therefore, the area most likely to benefit from oral BC ingestion as BC components can bind / affect the mucosa directly. Several studies have reported positive effects of BC for treating or preventing infectious diarrhea in adults and children, many of them being performed in low-income countries due to the higher incidence of infectious diarrhea and suggest that hyperimmunized BC against specific pathogens has value in reducingAttorney Docket No.: 148548-001102 diarrhea. Positive results have also been reported using non-hyperimmunized BC, especially against rotavirus and E. co / z-induced diarrhea, due in part to the fact that “non-hyperimmunized” BC contains IgG targeted against many potential pathogens due to natural exposure, including Enterobacter, Klebsiella, Escherichia coli, and Klebsiella. A recent study of young children in Zambia and Zimbabwe showed that adding oral non-hyperimmunized BC to standard World Health Organization (WHO) treatment for severe acute malnutrition resulted in reduced gut and blood markers of inflammation and stimulated gut regeneration. The potential of BC for gut diseases is not, however, limited to infection as positive results from clinical trials have been reported in reducing non-steroidal anti-inflammatory drug (NSAID)-induced gut injury and in treating inflammatory bowel disease.

[0594] Unlike the normal adult situation, the premature neonatal human gut may allow luminal contents to pass into the mucosa. There is, therefore, interest in the use of BC for necrotizing enterocolitis. Although in vivo models (especially the pig) have shown positive effects, the few reports from clinical trials of the use of BC for the prevention and treatment of necrotizing enterocolitis have been less optimistic.

[0595] Athletes are at increased risk of suffering upper respiratory tract infections, especially during heavy training. Most studies examining the effect of BC on URTI in athletes have shown positive results, although no consistent change in ex vivo blood markers of immune modulation have been found. Some, but not all, studies have also shown BC may have value to support muscle growth, performance and aid post-exercise recovery in athletes.

[0596] 4.3 Egg and BC combination therapy: Egg and BC contain multiple antimicrobial, immunomodulatory, and repair components essential for host development / defense functions. Although some factors overlap in both products, e.g., lysozyme, many others do not. There is, therefore, optimism that enhanced activity, across a spectrum of conditions, may be found if egg and BC are combined, acting through complementary signalers and pathways (see FIG. 1). FIG. 1: Egg and BC have multiple complementary modes of action. Major pathways in enhancing immunity are shown, with the contribution of specific molecules from BC (red), egg (blue) or the same molecules in both BC and egg (green). Major nutrients and growth factors in egg and BC are also shown.

[0597] 4.3.1 NSAID and inflammatory bowel disease: The concept of added value / synergy when using egg and BC as a combination is supported by several in vitro and in vivo studies. Studies using the human gut cell line AGS showed synergistic responses in cell proliferation and pro-migratory activity if a 40:60 combination of egg and colostrum was used, compared to either egg or BC alone at the same total concentration. In the same paper, in vivo studies examining the protective effect of egg alone, BC alone or combination therapy for anAttorney Docket No.: 148548-001102 NSAID-induced small intestinal injury model and a DSS-induced colitis model both showed combination therapy had greater efficacy in reducing gut damage and inflammation, compared to results using egg or BC alone at the same total concentration (FIG. 2). FIG. 2: Effect of egg + BC combination therapy on NSAID-induced small intestinal injury in mice and DSS-induced colonic injury in rats. A) Normal small intestinal villi, B) Villi from animals treated with NSAID alone, C) Villi from animals who received NSAID + egg + BC, D) Normal colon, E) Colon of animals treated with DSS to cause colitis, F) Colon of animals given DSS and egg + BC. Egg + BC combination resulted in preservation of a nearly normal appearance of villi and colon. Protective effects were significantly higher with the combination (egg + BC), rather than egg or BC alone at the same total dose (not shown). Images are a reproduction.

[0598] 4.3.2 Benefits of egg plus BC treatment for NSAID-associated stomach disorders: The egg plus BC combination treatment offers several therapeutic advantages for managing NS AID-associated gastrointestinal complications. The treatment may provide enhanced mucosal protection through the synergistic action of multiple bioactive components present in egg and BC. These benefits include accelerated healing of gastric and duodenal lesions through the presence of growth factors such as EGF, TGFa, and insulin-like growth factors that stimulate epithelial cell proliferation and migration. The combination may also offer superior antiinflammatory effects compared to either component alone, reducing the inflammatory cascade triggered by NSAID-induced prostaglandin inhibition. Additionally, the treatment provides comprehensive antimicrobial protection through IgG from bovine colostrum and IgY from egg products, which can prevent secondary bacterial infections in compromised gastric mucosa. The nutritional support provided by the macro- and micronutrients in both components further enhances the body's natural repair mechanisms, while the buffering capacity of proteins helps neutralize excess gastric acid that can exacerbate NSAID-induced injury.

[0599] 4.3.3 Mitigation of drug-induced intestinal damage: Beyond NSAID- associated complications, numerous other pharmaceutical agents often cause significant gastrointestinal side effects and intestinal damage. Broad-spectrum antibiotics, including fluoroquinolones, beta-lactams, and macrolides, frequently disrupt the normal intestinal microbiome, leading to antibiotic-associated diarrhea, Clostridioides difficile infections, and compromised gut barrier function. Chemotherapy agents such as 5 -fluorouracil, methotrexate, and irinotecan are particularly notorious for causing mucositis, intestinal inflammation, and severe diarrhea that can be dose-limiting and treatment-interrupting. Other medications known to cause intestinal damage include proton pump inhibitors (which alter gut pH and microbiome composition), immunosuppressive drugs like mycophenolate mofetil, and certain targeted cancer therapies, including tyrosine kinase inhibitors.Attorney Docket No.: 148548-001102

[0600] 4.3.4 The combination of bovine colostrum (BC) and hyperimmune egg products offers a promising approach to mitigate these drug-induced intestinal complications through multiple complementary mechanisms. BC provides immunoglobulins, particularly IgG, along with growth factors such as insulin-like growth factors, epidermal growth factor, and transforming growth factors that can promote intestinal epithelial repair and regeneration. The lactoferrin and lactoperoxidase in BC contribute antimicrobial activity while supporting beneficial bacterial growth. Hyperimmune egg products, containing specific IgY antibodies, can provide targeted protection against pathogenic bacteria that may proliferate during antibiotic treatment or in immunocompromised patients receiving chemotherapy. The lysozyme, ovotransferrin, and other antimicrobial peptides in egg products offer broad-spectrum protection against opportunistic pathogens, while the growth factors present in both egg and BC work synergistically to accelerate mucosal healing.

[0601] 4.3.5 The stabilization of beneficial intestinal microbiota represents a therapeutic advantage of the egg and BC combination. During antibiotic treatment, the normal gut microbiome is severely disrupted, creating an environment conducive to pathogen overgrowth and reducing the production of beneficial metabolites such as short-chain fatty acids. BC contains oligosaccharides and other prebiotic components that can selectively promote the growth of beneficial bacteria such as Bifidobacterium and Lactobacillus species. The immunomodulatory components in both BC and egg products help maintain a balanced immune response that supports commensal bacteria while controlling pathogenic species. This microbiome stabilization is also important in preventing secondary infections and maintaining gut barrier integrity during periods of pharmaceutical stress.

[0602] 4.3.6 Enhanced patient compliance and treatment adherence represent significant clinical benefits of incorporating egg and BC supplementation into therapeutic regimens. Gastrointestinal side effects are among the most common reasons for treatment discontinuation or dose reduction in both antibiotic and chemotherapy protocols. By reducing the severity and duration of drug-induced diarrhea, nausea, and abdominal discomfort, patients are more likely to complete their prescribed treatment courses at optimal dosing. This is particularly useful in oncology settings where treatment interruptions can compromise therapeutic outcomes, and in antibiotic therapy where incomplete courses contribute to antimicrobial resistance. The natural, food-based origin of these products also provides psychological comfort to patients who may be concerned about adding additional pharmaceutical interventions to their treatment regimen, thereby improving overall acceptance and adherence to the supplementation protocol.

[0603] 4.3.7 Environmental enteropathy / severe growth stunting: Combination therapy with egg and BC shows promise for the treatment of children with severe growth stuntingAttorney Docket No.: 148548-001102 in developing countries. This condition is often associated with environmental enteropathy, where repeated gut infections and inflammation damage the bowel lining. This causes shortening of small intestinal villi, reducing absorptive ability of nutrients, increasing metabolic requirements, and allowing bacterial colonization of the small intestine. A study of egg and BC in young children in Malawi showed benefits in reducing linear stunting, reducing gut permeability, and increasing the content of the probiotic Streptococcus thermophilus in the stool.

[0604] 4.3.8 Small intestinal bacterial overgrowth Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excess bacteria within the small intestine. SIBO causes bloating, flatulence, diarrhea, and abdominal discomfort, with symptoms overlapping those of irritable bowel syndrome, although both conditions may coexist. Risk factors for SIBO include altered intestinal anatomy, pancreatic insufficiency, hypothyroidism, and medications that impair gut motility (e.g., opiates) or reduce acid secretion (e.g., proton pump inhibitors).

[0605] 4.3.9 A mixed population of bacteria is often found in patients with SIBO, with some of the most common species being aerobes such as Streptococcus, Escherichia coli, Staphylococcus, and Klebsiella, and anaerobes such as Bacteroid.es, Lactobacillus, and Clostridium. Egg and BC combination therapy shows promise as a new therapeutic approach to prevent or treat SIBO. In vitro studies examining the effect of egg alone, BC alone, and egg + BC have shown each can stabilize the gut mucosa against a wide variety of microbes, including those commonly associated with SIBO, as well as protecting against the very toxic bacterial strains enteropathogenic Escherichia coli, and Salmonella. Positive effects included reducing bacterial translocation and gut cell apoptosis, in addition to stimulating gut protective factors such as ZO1 and claudin-1 levels. The relative potency of egg, BC, and the combination in producing these effects varied, depending on which microbe and which protective factor was measured.

[0606] 4.3.10. GLP-1 therapy for anti-obesity and diabetes control is rapidly increasing. However, its use is hampered by the high incidence of gastrointestinal side effects, such as nausea, vomiting, diarrhea and constipation, which occur in 40-70% of patients and may cause patients to discontinue therapy. Current advice to alleviate symptoms mainly relates to reducing high-volume meals and other dietary recommendations, with a reluctance to introduce polypharmacy, such as anti-nausea or anti-motility medication. The use of egg and BC is, therefore, appealing as a novel natural-based approach, stabilizing the gut mucosa, providing micronutrients at a time of calorie deficit, and addressing dysbiosis, particularly as GLP-1 slowing gut transit may increase the risk of SIBO development. In support of this idea, a pilot qualitative study of the value of egg and BC to alleviate GI symptoms in 18 patients starting GLP-1 therapy reported that ten suffered gastrointestinal symptoms sufficient that they requested to try egg and BC, with all ten reporting symptomatic benefit while taking the product. (FIG. 3 and FIG. 4).Attorney Docket No.: 148548-001102These initial positive results are encouraging and provide incentive to perform follow-on studies such as double-blind randomized control trials.

[0607] 5. Limitations in the interpretation of results for the use of egg, BC, or combination treatment can be considered as those generic to nutraceutical research, and those specific to the products under examination. Nutraceuticals are usually marketed as health-food supplements, rather than a medicine, and for regulatory reasons, specific medical claims cannot be made. Advertising for BC (and to a lesser extent for egg), therefore, usually uses terms such as “to support immune or digestive health”, although there appears to be wide variation in marketing material regarding claims on 1. what conditions these products may be beneficial for and 2. their relative potency against their competitors. Compared to most nutraceutical products, there is a strong publication base regarding the potential value of BC for a wide variety of conditions. Similarly, egg, especially as a macronutrient and for its IgY antimicrobial activity, has been extensively researched for a variety of clinical situations. However, the prohibitive costs of major clinical trials means that, compared to large pharma drugs, nutraceutical clinical studies tend to be relatively small. As both egg and BC have a multitude of components, ensuring consistency in content is much harder than a single pharmaceutical agent. Differences in “quality / efficacy” of test products may underlie apparent inconsistencies in results between some studies. It is, therefore, important that major effort is put into ensuring a consistent product, as demonstrated by the finding that the bioactivity of different BC commercial products varies widely (6-fold), despite reporting similar total protein and IgG content, which may be due in part to destruction of bioactivity during production and storage. Claims of enhanced immune or growth bioactivity of any marketed product should, therefore, be based on results of a relevant bioassay, rather than relying on IgG, or total protein quantitative assay.

[0608] Because there are very few studies examining dose-responses in clinical trials, the optimal dose of egg, BC or combination for human use is uncertain. The issue of optimal dose is further compounded by the fact that different formulations of egg, BC, or combination will result in different stabilities of growth factors and immune factors, such as IgG, during their transit through the stomach and small intestine. When taken by mouth, egg, BC, or combination are exposed to hydrochloric acid and pepsin (in the stomach), followed by bile and pancreatic enzymes such as trypsin and chymotrypsin (in the small intestine). Studies have shown that growth factor bioactivity and immunoglobulin binding ability are adversely affected by HCl / pepsin / trypsin / chymotrypsin exposure, but that this can be partially mitigated by the presence of specific proteins such as casein, soya bean trypsin inhibitor or egg ovomucoid, which act as preferred substrates for the proteolytic enzymes. The presence of these specific proteins causes stabilization of the growth factor and immune components of egg, BC, or combination within theAttorney Docket No.: 148548-001102 lumen, allowing the growth and immune factors to travel intact to the distal parts of the gastrointestinal tract to enhance gut integrity and repair. Interestingly, not all proteins have this protective effect, with lactalbumin (present in whey) not showing any protective ability, which is probably related to the relative affinity of pepsin / pancreatic enzymes to the protein versus the growth or immune factor. The combination of egg and whole BC, therefore, has the added advantage of maximizing the biostability of immune and growth factors through egg protein constituents such as ovomucoid and the casein content within whole (or defatted or minimally processed) BC. It is, therefore, important that the formulation of BC with or without gg being administered is taken into consideration when determining the probable relative potency and dosing requirements for human use. Finally, although both egg and BC are generally considered safe, consumers with egg or milk allergies should probably avoid their use.

[0609] 6. Conclusions: Egg and BC are rich sources of macro- and micro -nutrients and bioactive molecules affecting immunity, growth, and repair. In the health supplement / medicinal food space, egg and BC combination therapy has several advantages over supplements comprising a single ingredient; both are considered as being comprehensive “superfoods”, with public appreciation of their links to nature. Both subcomponents have a strong safety profile, underpinned by quality scientific publications regarding their efficacy, relevance across all age groups, and are presented in a natural formulation that limits their own inactivation when taken orally. The synergistic effects when given together provide additional reasons to support consumer and patient acceptance / compliance to optimize immune and digestive health.

[0610] Abbreviations: EGF; Epidermal growth factor, EGFR; Epidermal growth factor receptor, IGF; insulin-like growth factor, IL; interleukin, NSAID; Nonsteroidal antiinflammatory drugs, TGF-; Transforming growth factorExample 2: Bovine colostrum and chicken egg reduce GLP-1 induced gastrointestinal symptoms in non-diabetic subjects. Results of a pilot study.

[0611] Two nutraceutical products with potential value for the treatment of a wide range of conditions are chicken egg and bovine colostrum (BC). Both are natural-based food products and have GRAS (generally regarded as safe) status in the USA. Both have a strong preclinical publication base demonstrating efficacy in a wide range of in vitro and in vivo situations, with a limited number of clinical trials.

[0612] GLP-1 therapy for anti-obesity / diabetes control is being increasingly used but is hampered by a high incidence of gastrointestinal side effects (nausea, vomiting, bloating, diarrhea, and constipation), which occur in 40-70% of patients and may cause patients to discontinue therapy. (2) Current advice to alleviate symptoms mainly relates to reducing high- volume meals and other dietary restrictions, with a reluctance to introduce polypharmacy, such asAttorney Docket No.: 148548-001102 anti-nausea or motility-altering medication. The use of egg and BC is, therefore, appealing as a novel, natural-based approach, stabilizing the gut mucosa, providing micro-nutrients at a time of calorie deficit, and addressing dysbiosis, particularly as the slowing of gut transit by GLP-1 may increase the risk of SIBO development. We examined whether a combination of egg powder + BC mitigated GLP-1 -induced GI side effects.

[0613] Patient recruitment: GLP-1 was initiated on clinical grounds. Only nondiabetic patients were recruited to reduce cohort variability. Patients were recruited from three USA-based centers: Cleveland Clinic, University of Maryland, and Middletown, OH.

[0614] Symptom questionnaire. Patients used a predetermined questionnaire regarding symptoms of: 1. nausea, 2. boating, 3. constipation, 4. diarrhea, 5. overall benefit, and a final free space for comments. These were graded as no improvement, mild, moderate, major, or not applicable.

[0615] Product & dosing: The test product was administered as sachets containing 7g of a 55:45 ratio egg + BC (Relesium™, Pantheryx Inc, Boulder, Colorado). Both the BC and egg components were lightly pasteurized into powder form with a 7g sachet containing 2g fat and 3 g protein. Patients were advised they could take up to 3 sachets per day if they considered their symptoms warranted it.

[0616] Of the 32 subjects enrolled, 20 subjects (62.5%) developed GI side effects requiring additional treatment. The symptomatic group comprised 8 male subjects, 12 female subjects, 2 subjects aged 18-24, 4 subjects aged 35-44, 4 subjects aged 45-54 years, 6 subjects aged 55-64 years, 4 subjects >65 years. 12 subjects were given weekly tirzepatide; 5 subjects were dosed at 2.5mg, 2 subjects were dosed at 5mg, 1 subject was dosed at 7.5mg, 2 subjects were dosed at lOmg, and 1 subject was dosed at 12.5 mg. 8 subjects were given semaglutide at doses between 1 mg and 2 mg / week. The median dose of egg + BC taken was one sachet / day (range 1- 2).

[0617] Of the 20 symptomatic subjects:

[0618] An overall benefit of egg +BC was reported by 19 / 20 subjects (1 / 19 no change, 10 / 19 mild / slight benefit, 9 / 19 major benefit, see FIG. 5).

[0619] Individual symptom responses are shown in FIG. 3 and FIG. 4.

[0620] Nausea was reported by 16 / 20 subjects, with egg + BC providing a mild / slight benefit in six subjects, moderate benefit in five subjects, and major improvement in five subjects.

[0621] Diarrhea was reported by 13 / 20 subjects, with egg + BC providing mild / slight improvement in five subjects, moderate improvement in three subjects, and major improvement in five subjects.Attorney Docket No.: 148548-001102

[0622] Constipation was reported by 8 / 20 subjects, with egg + BC providing no improvement in one subject, mild / slight improvement in three subjects, moderate improvement in one subject, and major improvement in three subjects.

[0623] Abdominal pain was reported by 8 / 20 subjects, with egg + BC providing no improvement in one subject, mild / slight improvement in five subjects, and moderate improvement in two subjects.

[0624] Bloating was reported by 7 / 20 subjects, with egg + BC providing no improvement in one subject, mild / slight improvement in two subjects, and moderate improvement in four subjects.

[0625] Heartbum / Reflux: Four subjects reported improvement in heartburn / reflux after taking egg + BC in the free text section.

[0626] GI side effects occurred frequently following GLP-1 treatment, with an overall benefit of egg + BC reported by 95% of symptomatic subjects.

[0627] Potential mechanisms of action include protection against irritation from increased contact time of acid / enzymes due to gut slowing, protein content assisting pH-buffering, IgG / IgY and other antimicrobial factors reducing dysbiosis, small intestine bacterial overgrowth, and fermentation of food products in the small intestine.

[0628] Egg + BC may provide a natural, non-pharmacological approach, without diminishing the efficacy of GLP-1.Example 3: Bovine colostrum and chicken egg reduce NSAID-induced gastrointestinal symptoms.

[0629] In one embodiment, a 52-year-old female patient presenting with gastric irritation, abdominal pain, and mild gastric erosions associated with chronic ibuprofen use for rheumatoid arthritis is administered a composition comprising bovine colostrum and egg product at a dose of 7g twice daily. The composition contains a 3:2 ratio of bovine colostrum to egg product on a dry weight equivalent basis. After a 6-week treatment period, the patient's symptoms are expected to show significant improvement, with reduced gastric pain, decreased inflammation markers, and healing of gastric erosions as confirmed by endoscopic examination. The protective effects are anticipated to result from the synergistic action of immunoglobulins, growth factors, and antimicrobial peptides present in both bovine colostrum and egg product, which may stabilize the gut mucosa and promote tissue repair while providing buffering capacity against gastric acid irritation. This example demonstrates the efficacy of the egg and bovine colostrum combination in treating NSAID-associated gastrointestinal symptoms without requiring discontinuation of necessary anti-inflammatory therapy.Attorney Docket No.: 148548-001102

[0630] Although the invention has been described with reference to the aboye examples, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.

Claims

1. PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-001102CLAIMSWhat is claimed, is:

1. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of a colostrum product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

2. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

3. A method for treating gastrointestinal side effects of administration of a pharmaceutical agent, the method comprising administering to a subject an effective amount of a composition, wherein the composition comprises an effective amount of a colostrum product and an egg product; wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NS AID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

4. The method of claim 3, wherein the colostrum product is a bovine colostrum product.

5. The method of claim 3, wherein the colostrum product is a human colostrum product.

6. The method of claim 4, wherein the bovine colostrum product comprises subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-0011027. The method of claim 6, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulins, casein, IgG, lactoferrin, lactoperoxidase, a- lactalbumin, glycomacropeptide, P-lactoglobulin, growth factors, and combinations thereof.

8. The method of claim 6, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

9. The method of claim 6, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

10. The method of claim 6, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.

11. The method of claim 6, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

12. The method of claim 6, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

13. The method of claim 6, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocyte-macrophage colony-stimulating factor, and interleukin l [:l, interleukin 6, interleukin 10, colostrinin / proline-rich polypeptide (PRP), and combinations thereof.

14. The method of claim 6, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulin-like growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor [I, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

15. The method of claim 3, wherein the egg product is a whole egg.

16. The method of claim 3, wherein the egg product is a fowl egg.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110217. The method of claim 3, wherein the egg product is a chicken egg.

18. The method of claim 3, wherein the egg product comprises subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

19. The method of claim 18, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin, ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.

20. The method of claim 18, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.

21. The method of claim 18, wherein the egg product is a vitamin, and the vitamin is selected from vitamin B12, vitamin D, riboflavin, choline, and combinations thereof.

22. The method of claim 18, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

23. The method of claim 18, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

24. The method of claim 18, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

25. The method of claim 18, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

26. The method of claim 18, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth factor-^ (TGF-P), and combinations thereof.

27. The method of claim 3, wherein the egg product is an immune egg.

28. The method of claim 3, wherein the egg product is a hyperimmune egg.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110229. The method of claim 3, wherein the egg product is a non-hyperimmune egg.

30. The method of claim 3, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 1 : 10 to about 10: 1.

31. The method of claim 3, wherein the effective amount of the composition comprises colostrum product and egg product in a ratio of about 3:2.

32. The method of claim 3, wherein the subject is being treated with the pharmaceutical agent for diabetes or weight loss.

33. The method of claim 3, wherein the composition is used to manage the gastrointestinal side effects without use of additional pharmaceuticals for symptom relief.

34. The method of claim 3, wherein the gastrointestinal side effects are selected from the group consisting of nausea, vomiting, diarrhea, constipation, bloating, and abdominal pain.

35. The method of claim 3, wherein the pharmaceutical agent is selected from the group consisting of tirzepatide, exenatide, liraglutide, dulaglutide, semaglutide, lixisenatide, albiglutide, taspoglutide, and combinations thereof.

36. The method of claim 3, wherein the composition is administered without requiring a dosage adjustment of the pharmaceutical agent.

37. The method of claim 3, wherein the composition is administered orally.

38. The method of claim 3, wherein the composition is used to manage gastrointestinal side effects without additional pharmaceuticals for symptom relief.

39. The method of claim 3, wherein the composition is administered at the same time as administration of the pharmaceutical agent.

40. The method of claim 3, wherein the composition is administered prior to administration of the pharmaceutical agent.

41. The method of claim 3, wherein the composition is administered subsequent to administration of the pharmaceutical agent.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110242. The method of claim 3, wherein the composition is administered at regular intervals throughout a day.

43. The method of claim 3, wherein the composition is administered once per week.

44. The method of claim 3, wherein the composition is administered about once per week to about 7 times per week.

45. The method of claim 3, wherein the composition is administered as needed to manage gastrointestinal side effects.

46. The method of claim 3, wherein the composition is administered once per day.

47. The method of claim 3, wherein the composition is administered multiple times per day.

48. The method of claim 3, wherein the composition is administered twice per day.

49. The method of claim 3, wherein the composition is administered four twice per day.

50. The method of claim 3, wherein the composition is administered as a single dose.

51. The method of claim 50, wherein the single dose of the composition is about 7 g to about 14 g.

52. The method of claim 50, wherein the single dose of the composition is about 7 g.

53. The method of claim 3, wherein the composition is administered in a regimen adjusted based on a severity of the gastrointestinal side effects experienced by the subject.

54. The method of claim 3, wherein the composition further comprises one or more additional active agents.

55. The method of claim 54, wherein the one or more additional active agents is an H2 receptor blocker.

56. The method of claim 55, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110257. The method of claim 54, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

58. The method of claim 54, wherein the one or more additional active agents is an antinausea medication.

59. The method of claim 58, wherein the antinausea medication is ondansetron.

60. The method of claim 54, wherein the one or more additional active agents is a prokinetic medication.

61. The method of claim 60, wherein the prokinetic medication is metoclopramide.

62. The method of claim 54, wherein the one or more additional active agents is an antimotility drug.

63. The method of claim 54, wherein the one or more additional active agents is a nonabsorbable antibiotic.

64. The method of claim 63, wherein the non-absorbable antibiotic is rifaximin.

65. The method of claim 3, wherein the method further comprises administering one or more additional components selected from the group consisting of a vitamin, mineral, amino acid, antioxidants, and combinations thereof.

66. The method of claim 65, wherein the vitamin is selected from the group consisting of vitamin A, vitamin C, folic acid, and combinations thereof.

67. The method of claim 66, wherein the vitamin A is in an amount of about 100 pg to about 1000 pg.

68. The method of claim 66, wherein the vitamin C is in an amount of about 15 mg to about 60 mg.

69. The method of claim 66, wherein the folic acid is in an amount of about 80 pg to about 600 pg.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110270. The method of claim 65, wherein the mineral is selected from the group consisting of iron, zinc, and combinations thereof.

71. The method of claim 70, wherein the iron is in an amount of about 0.5 mg to about 18 mg.

72. The method of claim 3, wherein the composition is administered daily.

73. The method of claim 3, wherein the composition further comprises a probiotic component comprising one or more live microorganisms.

74. The method of claim 3, wherein the composition further comprises a prebiotic component comprising one or more types of dietary fiber.

75. The method of claim 3, wherein the composition is formulated as a capsule, tablet, powder, or liquid.

76. The method of claim 3, wherein the composition provides nutrients and immune factors that restore normal intestinal function.

77. The method of claim 3, wherein the composition is marketed as a food for special dietary use.

78. The method of claim 3, wherein the subject is an adult.

79. The method of claim 3, wherein the subject is a child.

80. The method of claim 3, wherein administering the composition reduces small intestinal bacterial overgrowth of the subject.

81. The method of claim 3, wherein administering the composition protects a gut from irritation by pancreatic enzymes and bile.

82. The method of claim 3, wherein the gastrointestinal side effects are a result of a small intestinal bacterial overgrowth (SIBO) of the subject.

83. The method of claim 82, wherein the SIBO is measured using hydrogen breath testing.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110284. The method of claim 83, wherein the SIBO of the subject is >12ppm greater than a baseline or control measurement of SIBO after lactulose or the SIBO of the subject is >20 ppm greater than a baseline or control measurement of SIBO after a glucose challenge.

85. The method of claim 84, wherein the SIBO is measured by small intestine aspirate.

86. The method of claim 85, wherein the SIBO is measured by fluid culture.

87. The method of claim 86, wherein the SIBO is measured using methane breath testing.

88. The method of claim 3, wherein the NSAID is a COX-2 inhibitor.

89. The method of claim 88, wherein the COX -2 inhibitor is selected from the group consisting of celecoxib, rofecoxib, valdecoxib, lumiracoxib, etoricoxib, parecoxib, and combinations thereof.

90. The method of claim 3, wherein the NSAID is selected from the group consisting of aspirin, ibuprofen, naproxen, celecoxib, ketoprofen, indomethacin, and combinations thereof.

91. The method of any one of claims 3 to 90, wherein the method treats or prevents a drug- induced injury.

92. The method of claim 91, wherein the drug-induced injury is selected from the group consisting of gastrointestinal bleeding, a bleeding ulcer, a gastrointestinal obstruction, a gastrointestinal perforation, gastrointestinal erosion, gastrointestinal tract mucosal injury, and combinations thereof.

93. The method of claim 88, further comprising administering an additional pharmaceutical agent.

94. The method of claim 93, wherein the additional pharmaceutical agent is selected from the group consisting of a proton pump inhibitor, a histamine type 2 (H2) receptor antagonist, misoprostol, and combinations thereof.

95. The method of claim 94, wherein the proton pump inhibitor is omeprazole or esomeprazole.

96. The method of claim 95, wherein the (H2) receptor antagonist is selected from the group consisting of ranitidine, nizatidine, cimetidine, famotidine, and combinations thereof.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-00110297. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising a colostrum product.

98. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising an egg product.

99. A kit for weight loss, the kit comprising: a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide-1 (GLP- 1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof; and a properly titrated composition comprising a colostrum product and an egg product.

100. The kit of claim 99, wherein the properly titrated composition is administered orally.

101. The kit of claim 99, wherein the properly titrated composition is one to fourteen single doses.

102. The kit of claim 99, wherein the properly titrated composition is a single dose.

103. The kit of claim 102, wherein the single dose of the properly titrated composition is about 7 g to about 14 g.

104. The kit of claim 102, wherein the single dose of the properly titrated composition is about 7 g.

105. The kit of claim 99, wherein the properly titrated composition further comprises one or more additional active agents.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-001102106. The kit of claim 105, wherein the one or more additional active agents is an H2 receptor blocker.

107. The kit of claim 106, wherein the H2 receptor blocker is selected from the group consisting of omeprazole, simethicone, and combinations thereof.

108. The kit of claim 105, wherein the one or more additional active agents are selected from the group consisting of omeprazole, simethicone, ondansetron, metoclopramide, rifaximin, and combinations thereof.

109. The kit of claim 105, wherein the one or more additional active agents is an antinausea medication.

110. The kit of claim 109, wherein the antinausea medication is ondansetron.

111. The kit of claim 105, wherein the one or more additional active agents is a prokinetic medication.

112. The kit of claim 111, wherein the prokinetic medication is metoclopramide.

113. The kit of claim 105, wherein the one or more additional active agents is an antimotility drug.

114. The kit of claim 105, wherein the one or more additional active agents is a nonabsorbable antibiotic.

115. The kit of claim 114, wherein the non-absorbable antibiotic is rifaximin.

116. A composition comprising an effective amount of a colostrum product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

117. A composition comprising an effective amount of an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selectedPCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-001102 from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

118. A composition comprising an effective amount of a colostrum product and an egg product; wherein the effective amount of the composition is effective to treat gastrointestinal side effects of administration of a pharmaceutical agent, wherein the pharmaceutical agent is selected from the group consisting of a non-steroidal anti-inflammatory drug (NSAID), a glucagon-like peptide- 1 (GLP-1) receptor agonist, a gastric inhibitory polypeptide (GIP) receptor agonist, a dual GIP / GLP-1 receptor co-agonist, and combinations thereof.

119. The composition of claim 118, wherein the colostrum product is a bovine colostrum product.

120. The composition of claim 118, wherein the colostrum product is a human colostrum product.

121. The composition of claim 119, wherein the bovine colostrum product comprises subcomponents selected from a protein, a carbohydrate, a lipid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a hormone, a cytokine, a growth factor, and combinations thereof.

122. The composition of claim 121, wherein the bovine colostrum product is a protein, and the protein is selected from immunoglobulin, casein, IgG, lactoferrin, lactoperoxidase, a- lactalbumin, glycomacropeptide, P-lactoglobulin, growth factor, and combinations thereof.

123. The composition of claim 121, wherein the bovine colostrum product is a carbohydrate, and the carbohydrate is selected from lactose, glycoprotein, glycolipid, nucleotide sugars, and combinations thereof.

124. The composition of claim 121, wherein the bovine colostrum product is a lipid, and the lipid is selected from gangliosides, phospholipids, and combinations thereof.

125. The composition of claim 121, wherein the bovine colostrum product is a mineral, and the mineral is selected from calcium, iron, zinc, magnesium, manganese, copper, phosphorus, and combinations thereof.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-001102126. The composition of claim 121, wherein the bovine colostrum product is a bioactive factor, and the bioactive factor is selected from immunoglobulin (IgG), lysozyme, lactoperoxidase, lactoferrin, and combinations thereof.

127. The composition of claim 121, wherein the bovine colostrum product is a hormone, and the hormone is selected from prolactin, growth hormone, somatostatin, oxytocin, insulin-like growth factor- 1, luteinizing hormone-releasing hormone, calcitonin, thyroid-stimulating hormone, thyroxine, progesterone, estrogen, and combinations thereof.

128. The composition of claim 121, wherein the bovine colostrum product is a cytokine, and the cytokine is selected from tumor necrosis factor-a, granulocyte -macrophage colonystimulating factor, and interleukin l [:l, interleukin 6, interleukin 10, colostrinin / proline-rich polypeptide (PRP), and combinations thereof.

129. The composition of claim 121, wherein the bovine colostrum product is a growth factor, and the growth factor is selected from insulin-like growth factor, somatomedin, epidermal growth factor, transforming growth factor a, betacellulin, transforming growth factor [I, bovine colostral growth factor, vascular endothelial growth factor, and combinations thereof.

130. The composition of claim 118, wherein the egg product is a whole egg.

131. The composition of claim 118, wherein the egg product is a fowl egg.

132. The composition of claim 118, wherein the egg product is a chicken egg.

133. The composition of claim 118, wherein the egg product comprises subcomponents selected from a protein, a fatty acid, a vitamin, a mineral, an antimicrobial factor, a bioactive factor, a cytokine, a growth factor, and combinations thereof.

134. The composition of claim 133, wherein the egg product is a protein, and the protein is selected from albumin, ovalbumin, ovotransferrin, ovomucoid, ovoglobulin, ovomucin, and lysozyme, immunoglobulins, apolipoprotein B, apovitellenin-1, vitellogenins, and combinations thereof.

135. The composition of claim 133, wherein the egg product is a fatty acid, and the fatty acid is selected from linoleic acid, cholesterol, and combinations thereof.PCT / US25 / 48145 26 September 2025 (26.09.2025)Attorney Docket No.: 148548-001102136. The composition of claim 133, wherein the egg product is a vitamin, and the vitamin is selected from vitamin B12, vitamin D, riboflavin, choline, and combinations thereof.

137. The composition of claim 133, wherein the egg product is a mineral, and the mineral is selected from phosphorus, calcium, and potassium, and contains all essential trace elements such as copper, selenium, zinc, iron, magnesium, manganese, and combinations thereof.

138. The composition of claim 133, wherein the egg product is an antimicrobial factor, and the antimicrobial factor is selected from IgY, lysozyme, avian beta defensins, ovotransferrin, avidin, ovoinhibitor, cystatin, trypsin or chymotrypsin, and combinations thereof.

139. The composition of claim 133, wherein the egg product is a cytokine, and the cytokine is selected from lysozyme, egg-white pleiotrophin, and combinations thereof.

140. The composition of claim 133, wherein the egg product is a cytokine, and the cytokine is a sulfated glycoprotein generated by proteolysis from proteins selected from ovomucin, chalazae, yolk membrane, and combinations thereof.

141. The composition of claim 133, wherein the egg product is a growth factor, and the growth factor is selected from ovomucoid, ovalbumin, epidermal growth factor (EGF), and transforming growth factor-^ (TGF-P), and combinations thereof.

142. The composition of claim 118, wherein the egg product is an immune egg.

143. The composition of claim 118, wherein the egg product is a hyperimmune egg.

144. The composition of claim 118, wherein the egg product is a non-hyperimmune egg.

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