Uses of a probiotic and psyllium for preparing compositions to improve digestive health in an animal.

Description

[001] This application claims the benefit of and priority over provisional patent application serial number US 63 / 034,030, filed June 3, 2020, and over provisional patent application serial number US 63 / 032,033, filed May 29, 2020, the contents of which are incorporated in their entirety into the present invention by means of this reference. BACKGROUND

[002] The intestinal tract plays a critically important role in the health and well-being of the animal. To help fulfill this function, the intestinal tract contains diverse microorganisms that comprise a healthy gastrointestinal microflora under normal conditions. The microflora confers many benefits to the animal, for example, the production of fatty acids that nourish the cells lining the gastrointestinal lumen, the synthesis of vitamins, and the synthesis of enzymes that aid in the breakdown and digestion of food. Furthermore, the microflora assists the immune system in protecting the host against disease. For example, the microflora is known to inhibit the attachment and colonization of potential pathogens in the gastrointestinal tract and to stimulate the production of cytokines and immunoglobulins.

[003] Unfortunately, disruption of the normal balance of microflora can result in an opportunistic infection of the gastrointestinal tract and can facilitate further complications such as diarrhea and dehydration. The normal balance of microflora can be disrupted by various means, for example, stress, advanced age, travel, consumption of contaminated food or water, antibiotic therapy and Petition 870260049983, dated 05 / 26 / 2026, page 7 / 71 2 / 26 similar. One method for preventing or treating such an undesirable disturbance involves administering probiotics prophylactically to an animal to prevent the disturbance or administering probiotics therapeutically to an animal to restore the normal balance of microflora and facilitate recovery from the resulting undesirable complications caused by the problem.

[004] Probiotics and their benefits for animal health are well known to those skilled in the art. Probiotics are microorganisms that have a beneficial effect in the prevention and treatment of specific medical conditions when ingested. Probiotics are believed to exert biological effects through a phenomenon known as resistance to colonization. Probiotics facilitate a process by which the native anaerobic flora limits the concentration of potentially harmful (mostly anaerobic) bacteria in the digestive tract. Other modes of action, such as the supply of enzymes or the influence of enzymatic activity in the gastrointestinal tract, may also be responsible for some of the other functions attributed to probiotics. Probiotics are known to improve intestinal function, stimulate the immune system, reduce inflammation, and decrease the population of harmful microorganisms in the gastrointestinal tract.

[005] Although probiotics are generally useful for promoting an animal's health, they are often difficult to store, handle, and administer to the animal. Probiotics can be unstable under normal environmental conditions and require special handling, for example, refrigeration, freeze-drying, or other means to prolong the probiotic's shelf life. Similarly, probiotics are often unpleasant to the palate of the animal consuming them. Frequently, palatability needs to be disguised or improved with the use of other compounds or compositions. Additionally, it may Petition 870260049983, dated 05 / 26 / 2026, page 8 / 71 3 / 26 It may be beneficial to supplement the immune system, particularly in the gastrointestinal tract, using ingredients in combination with probiotics to obtain the maximum benefit from probiotic administration. Additionally, achieving therapeutic amounts can be challenging. Therefore, there is a need for new compositions containing probiotics that can overcome these challenges. SUMMARY

[006] The present description refers, in general, to food compositions for pets; methods for improving the microbiome in an animal; and methods for improving or treating gastrointestinal problems in animals. Additional modalities include the treatment or prevention of diarrhea, increasing or improving fecal quality, and increasing or improving digestive health.

[007] In one embodiment, a pet food composition may comprise a probiotic comprising at least one of any suitable strain or subspecies of Enterococcus and psyllium in an amount of about 20% by weight to about 80% by weight.

[008] In another embodiment, a method for improving the microbiome in an animal may comprise administering to the animal a composition comprising a probiotic and psyllium, wherein the probiotic comprises at least one of any suitable strain or subspecies of Enterococcus.

[009] Other uses include treatment or prevention of diarrhea, increasing or improving stool quality, and increasing or improving digestive health by administering the compositions described herein.

[0010] Additional features and advantages are described in the present invention, and will become apparent from the detailed description that follows. Petition 870260049983, dated 05 / 26 / 2026, page 9 / 71 4 / 26 DETAILED DESCRIPTION Definitions

[0011] As used in this description and the accompanying claims, the singular forms a, an, or include plural references unless the context clearly indicates otherwise. Thus, for example, the reference to a composition or the composition includes two or more compositions. The term and / or used in the context of X and / or Y should be interpreted as X or Y or X and Y. When used herein, the terms example and such, particularly when followed by a list of terms, are merely exemplary and illustrative and should not be considered exclusive or comprehensive.

[0012] The term animal means any animal that can benefit from the present compositions, including humans, birds, cattle, dogs, horses, cats, hircines, lupines, mice, sheep or pigs. In one aspect, the animal may be a mammal. In another embodiment, the animal may be a pet.

[0013] The term pet means domestic animals, such as cats, dogs, rabbits, guinea pigs, ferrets, hamsters, mice, gerbils, horses, cows, goats, sheep, donkeys, pigs and the like. In one sense, a pet can be a dog. In another sense, a pet can be a cat.

[0014] As used herein, the term "about" is understood as referring to numbers within a range of numerals, for example the range of -10% to +10% of the reference number, within -5% to +5% of the reference number, or in one aspect within -1% to +1% of the reference number, and in a specific aspect within -0.1% to +0.1% of the reference number. Furthermore, all numeral ranges in this document should be understood as including all Petition 870260049983, dated 05 / 26 / 2026, p. 10 / 71 5 / 26 whole, fractional or non-fractional numbers within the range. Furthermore, these numerical ranges should be interpreted as supporting a claim directed to any number or subset of numbers that is within that range. For example, a description of 1 to 10 should be interpreted as encompassing a range of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, and so on.

[0015] All percentages indicated in this document refer to the total weight of the food composition, except where otherwise indicated. When reference is made to pH, the values ​​correspond to pH measured at 25°C with standard equipment. A quantity may be the total amount of the component mentioned per portion of the composition or per distinct unit of the composition, and / or may be the percentage by weight of the component mentioned per dry weight.Furthermore, a quantity includes zero; for example, mentioning a quantity of a compound does not necessarily mean that the compound is present, unless followed by a range that excludes zero.

[0016] The terms pet food, pet food product, and pet food composition mean a product or composition intended for ingestion by a canine or feline that provides at least one nutrient to the animal. Additionally, in this sense, these terms mean that the product or composition is in a ready-to-eat form and is not merely an intermediate from which a consumable product or composition is produced, although other food compositions may be added in some forms, such as a dietary supplement. The term pet food means any food composition intended to be consumed by a canine or feline.

[0017] The term effective quantity means a quantity of a Petition 870260049983, dated 05 / 26 / 2026, p. 11 / 71 6 / 26 compound of this invention that (i) treats or prevents a specific disease, condition or disorder, (ii) attenuates, improves or eliminates one or more symptoms of the specific disease, condition or disorder, or (iii) prevents or delays the onset of one or more symptoms of the specific disease, condition or disorder described in this document. In one embodiment, the present probiotic and psyllium may be present in an amount effective to improve the microbiome, improve or treat gastrointestinal problems, treat or prevent diarrhea, increase or improve stool quality and / or increase or improve digestive health.

[0018] Dosages expressed here are in milligrams per kilogram of body weight per day (mg / Kg / day), unless otherwise stated.

[0019] The term long-term administration means periods of repeated administration or consumption exceeding one month. Periods longer than two, three, or four months may be used for certain modalities. Furthermore, more extended periods may be used and include more than 5, 6, 7, 8, 9, or 10 months. Periods exceeding 11 months or 1 year may also be used. Long-term use extending for 1, 2, 3, or more years is included in the invention. For certain aging canines, the canine will continue to consume on a regular basis for the remainder of its life. This may also be referred to as consumption over extended periods.

[0020] The term regular base or regular administration means at least one monthly dose with the compositions or with the consumption of the compositions and, in one aspect, means at least one weekly dose. More frequent dosing or consumption, such as two or three times a week, may also occur in certain modalities. Still, in other modalities, regimens may be Petition 870260049983, dated 05 / 26 / 2026, p. 12 / 71 7 / 26 used, comprising at least one daily consumption. A frequency, regardless of whether it is expressly exemplified in the present invention, that enables the maintenance of a desired activity level of the measured compound, such as a probiotic, within acceptable ranges may be useful in the present invention. Those skilled in the art will understand that feeding quantities will be a function of the composition being consumed or administered, as well as the animal consuming the feed, and some feed compositions may require more or less frequent administration to maintain a desired activity level of the measured compound (e.g., a probiotic).

[0021] The relative terms enhance, increase, accentuate, decrease and the like refer to the effects of the composition disclosed herein (a composition comprising a probiotic and psyllium) in relation to a composition with a lower quantity or without such compositional elements, but otherwise identical.

[0022] A blended composition merely has at least two components that have at least one different characteristic from each other. In one aspect, the moisture content and water activity may be different in the context of the present description. In this sense, the description of a composition as blended does not imply that the blended composition has been subjected to processing, sometimes called blending, that is, mixing components in such a way that they are indistinguishable from each other, and, in one aspect, such processing is avoided when one component is mixed with the other components to form a blended composition (for example, mixing a dry component with a wet or semi-wet component). Furthermore, in a blended composition, each of the at least two components that have at least one different characteristic from each other may retain its identity and Petition 870260049983, dated 05 / 26 / 2026, page 13 / 71 8 / 26 distinct appearances.

[0023] Wet food is pet food that has a moisture content of about 50% to about 90%, preferably, and in one aspect, of about 70% to about 90%. Dry food means pet food that has a moisture content of less than about 20%, and in one aspect, less than about 15%, and in one specific aspect, less than about 10%. Semi-moist food means pet food that has a moisture content of about 20% to about 50%, and in one aspect, of about 25% to about 35%.

[0024] The term feed pellets is used synonymously with chunks in the present invention, and both terms mean pieces of dry or semi-moist pet food that may be pellet-shaped, or may be of any other shape, and may be made by slicing a food composition into separate pieces. Non-limiting examples of feed pellets include particulates; pellets; pet food chunks, dehydrated meat, meat analogues, vegetables and combinations thereof; and pet snacks such as dried meats or vegetables, rawhide and biscuits. A meat analogue is a meat emulsion product that resembles natural meat chunks in appearance, texture and physical structure.

[0025] The term complete and balanced in reference to a feed composition means a feed composition that contains all the required nutrients, known in adequate amounts and proportions, based on recommendations from recognized authorities in the field of animal nutrition, and which is therefore capable of serving as a single source of dietary intake to maintain life or promote production, without the addition of supplementary nutritional sources. Nutritionally balanced feed Petition 870260049983, dated 05 / 26 / 2026, page 14 / 71 9 / 26 for pets and nutritionally balanced pet food compositions are widely known and widely used in the art, for example, complete and balanced food compositions formulated according to the standards established by the Association of American Feed Control Officials (AAFCO) as of January 1, 2019.

[0026] The term dietary supplement means a product intended to be ingested in addition to a normal diet. Dietary supplements may be in any form, for example, solid, liquid, gel, tablets, capsules, powder and the like. In one aspect, they may be supplied in convenient dosage forms. In some embodiments, they may be supplied in bulk consumer packaging, such as bulk powders, liquids, gels or oils. In other embodiments, supplements may be supplied in bulk quantities that will be included in other food items, such as snacks, treats, supplement bars, drinks and the like.

[0027] The compositions disclosed herein may not contain any element not specifically disclosed herein. Thus, a description of an embodiment using the term comprising includes a description of embodiments that essentially consist of and consist of the components mentioned.Similarly, the methods presented in the present invention can be devoid of any step not specifically disclosed herein. Thus, a description of an embodiment using the term "comprising" includes a description of embodiments that essentially consist of and comprise the steps mentioned. Any embodiment disclosed herein can be combined with any other embodiment disclosed herein, unless explicitly or directly indicated otherwise. Petition 870260049983, dated 05 / 26 / 2026, p. 15 / 71 10 / 26

[0028] The present discussion of modalities, aspects, examples, etc., are independent in the sense that they can be applied to all methods and compositions. For example, a probiotic used in a food composition can also be used in the method to improve the microbiome of an animal and vice versa. Modalities

[0029] The present inventors have discovered that a food composition comprising an Enterococcus probiotic administered with psyllium can provide digestive health benefits in an animal, including an improved microbiome. One method for determining an improved microbiome includes measuring Lactobacillus, bifidobacteria, and Clostridia perfringens in the animal's microbiome. Animals administered with the compositions reported herein may have an increase in Lactobacillus and bifidobacteria, as well as a decrease in Clostridia perfringens compared to a comparable animal not administered with the compositions disclosed herein.

[0030] Thus, in one embodiment, a feed composition for an animal may comprise a probiotic comprising at least one of any suitable strain or subspecies of Enterococcus and psyllium in an amount of about 20% by weight to about 80% by weight.

[0031] Additionally, a method for improving the microbiome in an animal may comprise administering to the animal a composition comprising a probiotic and psyllium, wherein the probiotic comprises at least one of any suitable strain or subspecies of Enterococcus.

[0032] In general, the probiotic can be present in the composition in an effective quantity so that the animal gains digestive health benefits. In one form, each Petition 870260049983, dated 05 / 26 / 2026, page 16 / 71 11 / 26 gram of the composition may contain the probiotic in an amount of approximately 10⁵ colony-forming units (CFU) to approximately 10¹⁰ CFU. In other embodiments, each gram of the composition may contain from approximately 10⁷ CFU to approximately 10¹⁰ CFU, or even from approximately 10⁷ CFU to approximately 10⁹ CFU.

[0033] As discussed in this document, health benefits may include improved digestive health, treatment of diarrhea, increased stool quality, diversification of the microbiome, increased beneficial bacteria, for example, increased Lactobacillus and bifidobacteria, decreased harmful bacteria, for example, decreased Clostridia perfringens, or combinations thereof. In one aspect, the health benefit may include the complete resolution of diarrhea.

[0034] In general, probiotics can be administered to an animal in amounts of about one to about twenty billion CFU per day for the healthy maintenance of the intestinal microflora, preferably from about 10 million to about 10 billion live bacteria per day.

[0035] In general, psyllium may be present in the composition in an amount effective for the animal to gain digestive health benefits. In one embodiment, psyllium may be present in the composition in an amount of about 20% by weight to about 80% by weight. In other embodiments, psyllium may be present in an amount of about 30% by weight to about 70% by weight, or even from about 40% by weight to about 60% by weight.

[0036] Typically, the present compositions can be administered to the animal for a sufficient time to effect a change in the animal's microbiome. In one embodiment, the composition can be administered to the animal on a regular basis. In another embodiment, the composition can be administered long-term. The Petition 870260049983, dated 05 / 26 / 2026, p. 17 / 71 12 / 26 of the present compositions are generally food compositions, but they can also be administered as part of a dietary regimen in the form of supplements, treats, sachets, and the like. In one embodiment, the composition is a pet food composition. In another embodiment, the composition is a dietary supplement. In yet another embodiment, the composition is a sachet.

[0037] In general, the probiotic can be any suitable strain or subspecies of Enterococcus. In one embodiment, the probiotic may comprise Enterococcus faecium (SF68® from CerbiosPharma SA, also available as the Cernivet® LBC ME10 feed probiotic additive from Cerbios-Pharma SA). As discussed in this document, the probiotic may be added to the composition in sufficient quantities to provide a health benefit. In one embodiment, the probiotic may be microencapsulated. In this way, probiotics may be microencapsulated within a biocompatible microcapsule to improve or sustain the viability of the probiotics, particularly during storage. The microcapsule acts as a barrier to protect the probiotics from harmful environmental conditions such as fluctuations in temperature, oxygen, humidity, and light. The microcapsules comprise an active agent, for example, a probiotic core surrounded by a biocompatible shell or coating.Suitable materials for the preparation of biocompatible microcapsules and methods for encapsulation are known in the art – see, for example, US 6,974,592, assigned to Yan, US 6,969,530, assigned to Curtis et al., US 6,887,493, assigned to Shefer et al., US 6,303,355, assigned to Opara, and patent applications serial numbers US 10 / 507,359, assigned to Ubbink et al., and US 10 / 656,386, assigned to Simmons et al., the contents of each being incorporated herein by reference. The microcapsules may be... Petition 870260049983, dated 05 / 26 / 2026, p. 18 / 71 13 / 26 prepared for controlled release of probiotics after administration to an animal. In preferred embodiments, the microcapsules of the invention are in the range of about 0.1 mm to about 1.0 mm in diameter. In one embodiment, the probiotics are microencapsulated with a shellac-coated biopolymer matrix.

[0038] Additionally, the compositions disclosed herein may contain other ingredients. In one embodiment, the compositions may contain other prebiotics. Prebiotics include any substance that alters the composition of the gastrointestinal tract microflora by providing a substrate for the growth of microorganisms. Prebiotics include, but are not limited to, natural and synthetic oligosaccharides, soluble fibers, resistant starch, and gums. Oligosaccharides may be linear or branched. The prebiotic may be specifically chosen for its ability to improve the survival of the probiotic in the storage container or in an animal's gastrointestinal tract. The prebiotic may also be specifically chosen for its ability to improve the functionality of the probiotic in the animal or to complement the benefits of the probiotic.In general, prebiotics are administered in sufficient quantities to positively stimulate the healthy microflora present in the gastrointestinal tract, and to cause these beneficial bacteria to reproduce. Typical amounts are about 10 grams per serving, or about 5 percent to about 40 percent of the daily recommended dietary fiber intake for an animal.

[0039] In general, compositions may contain any amount of probiotics necessary to achieve a health benefit. For dietary supplement forms, such supplements may comprise from about 1% to about 90% probiotics, from about 1% to about 70% probiotics, or even from about 1%. Petition 870260049983, dated 05 / 26 / 2026, page 19 / 71 14 / 26 to about 50% probiotics.

[0040] In one embodiment, the composition may comprise at least one of the following: animal digest, dried brewer's yeast, vitamin C; vitamin E, beta-carotene, zinc proteinate, manganese proteinate, ferrous sulfate, copper proteinate, calcium iodate, and sodium selenite. In some embodiments, the composition may include at least two, at least three, at least four, at least five, or even at least six of the following: animal digest, dried brewer's yeast, vitamin C; vitamin E, beta-carotene, zinc proteinate, manganese proteinate, ferrous sulfate, copper proteinate, calcium iodate, and sodium selenite. In another embodiment, the composition may include each of the following: animal digest, dried brewer's yeast, vitamin C; vitamin E, beta-carotene, zinc proteinate, manganese proteinate, ferrous sulfate, copper proteinate, calcium iodate, and sodium selenite.

[0041] As discussed in this document, the present composition may include animal digest.Animal digests useful in the present invention may be any animal digest known to those skilled in the art, including liquid animal digests and dried animal digests. Such digests include any material resulting from chemical and / or enzymatic hydrolysis of clean, undecomposed animal tissue. Additionally, dried brewer's yeast may be useful in the present invention, which is any dried brewer's yeast known to those skilled in the art, for example, the inactive dry agent that is a byproduct of the brewing industry. It has been found that animal digest and dried brewer's yeast enhance the palatability of compositions, including dietary supplements and food compositions. When present in such compositions, animal digest comprises from about 1% by weight to about 90% by weight of the composition, and dried brewer's yeast comprises from about 1% by weight to about 30% by weight of the composition. Petition 870260049983, dated 05 / 26 / 2026, p. 20 / 71 15 / 26

[0042] Vitamin C, vitamin E, beta-carotene, zinc proteinate, manganese proteinate, ferrous sulfate, copper proteinate, calcium iodate, and sodium selenite are compounds known to those skilled in the art. These compounds have been found to improve immunity and enhance the action of probiotics in the dietary supplement of the present invention. It has also been found that all these compounds, animal digest, and dried brewer's yeast in combination prolong the life of probiotics compared to probiotics when not present in the compositions.When present in the food composition or supplement, the composition comprises from about 0.1% to about 10% vitamin C, from about 0.1% to about 10% vitamin E, from about 0.01% to about 3% beta-carotene, from about 0.1% to about 5% zinc proteinate, from about 0.01% to about 3% manganese proteinate, from about 0.01% to about 3% ferrous sulfate, from about 0.01% to about 1% copper proteinate, from about 0.01% to about 1% calcium iodate, and from about 0.001% to about 0.1% sodium selenite. In an additional embodiment, the food composition or dietary supplement further comprises from about 0.1% to about 2% taurine.

[0043] Regarding supplements, dietary supplements can be prepared as various formulations such as a powder, granule, pellet, or any other suitable release form. In some embodiments, the dietary supplement formulation may be a powder containing microencapsulated probiotics within a biopolymer matrix. The powdered dietary supplement may be sprinkled on or otherwise applied and mixed with a food or other composition, particularly a pet food such as dog food or cat food. Powdered dietary supplements may be specifically formulated for consumption by a particular animal, such as a pet. In a Petition 870260049983, dated 05 / 26 / 2026, page 21 / 71 In the 16 / 26 modality, the powdered dietary supplement comprises a high concentration of probiotics, so the supplement can be administered to the animal in small amounts, or alternatively, it can be diluted before administration to an animal. A professional skilled in the art may devise other delivery routes, such as providing the dietary supplement alone or providing it in, on, or with a pet treat.

[0044] Dietary supplements can be formulated for storage over extended periods at room temperature or, alternatively, can be refrigerated, freeze-dried, or frozen. In one embodiment, the dietary supplement can be stored at room temperature and the probiotics in the dietary supplement remain substantially viable for at least 22 days when stored at room temperature. Predictive modeling has shown that such probiotics remain substantially viable despite periodic short-term spikes in storage temperature that can exceed room temperature by up to 60 °C.

[0045] The compositions of the invention may comprise additional substances such as minerals, vitamins, salts, proteins, amino acids, fibers, spices, colorants, and preservatives. Non-limiting examples of minerals include calcium, phosphorus, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, selenium, and the like, and various salts thereof. Non-limiting examples of vitamins include vitamin A, various B-complex vitamins, for example, niacin, pantothenic acid, folic acid, biotin, vitamin D, and vitamin K. The compositions may also comprise carotenoids such as alpha-carotene, lycopene, lutein, zeaxanthin, and beta-cryptoxanthin. Additional ingredients may also be included, for example, inulin, amino acids, and the like. In a specific embodiment, the Petition 870260049983, dated 05 / 26 / 2026, page 22 / 71 Amino acid 17 / 26 could be taurine.

[0046] In various embodiments, the compositions of the invention may additionally comprise from about 15% to about 60% crude protein. In one embodiment, the compositions comprise from about 40% to about 55% crude protein. The crude protein material may comprise vegetable proteins such as soybeans, corn, rice, cottonseed, and peanuts, or animal proteins such as casein, albumin, and meat protein. Non-limiting examples of meat protein useful in the present invention include pork, lamb, horse, poultry, fish, and mixtures thereof.

[0047] The compositions may additionally comprise from about 5% to about 40% fat. In one embodiment, the compositions may comprise from about 15% to about 22% fat. The compositions may further comprise a carbohydrate source. The compositions may comprise from about 15% to about 60% carbohydrates. Non-limiting examples of such carbohydrates include grains or cereals such as rice, corn, sorghum, alfalfa, barley, soybeans, canola, oats, wheat, and mixtures thereof. The compositions may also optionally comprise other materials such as dried whey and other dairy by-products.

[0048] The compositions may also additionally comprise at least one fiber source. The compositions may comprise from about 0.5% to about 5% fiber. A variety of soluble or insoluble fibers may be used, as will be known to those skilled in the art. The fiber source may be beet pulp (from sugar beet), gum arabic, tallow gum, psyllium, rice bran, locust bean gum, citrus pulp, pectin, fructooligosaccharide, mannan-oligofructose, soy fiber, lupin fiber, arabinogalactan, gallate-oligosaccharide, arabinoxylan, or mixtures thereof. The fiber source may be a fermentable fiber, as are many of those Petition 870260049983, dated 05 / 26 / 2026, p. 23 / 71 18 / 26 mentioned above. It has been previously described that fermentable fiber provides a benefit to the immune system of pets. Fermentable fibers or other compositions known to those skilled in the art that provide a prebiotic composition that can enhance the growth of probiotics within the intestine may also be incorporated into the composition to help enhance the benefits provided by the present invention to the immune system, gastrointestinal system, and overall health of an animal.

[0049] In some embodiments where the composition is a supplement, to improve the length of time the supplement can be stored, dietary supplements may have a total moisture content between about 2% and about 10% by weight of the supplement. In one embodiment, the total moisture content may be less than 5% by weight of the supplement. Similarly, the dietary supplement may have a water activity in the range of 0.20 to 0.6. In one embodiment, the water activity may be less than 0.55.

[0050] Compositions can be specially formulated for specific animals, such as dogs or cats. Similarly, compositions can be specially formulated for young, adult, or senior animals. In general, specialized formulations comprise ingredients that meet the appropriate energy and nutritional requirements for specific animals and for specific animals at different stages of development or age, or with specific nutrient requirements related to a disease state.

[0051] In one embodiment, compositions may be formulated for dogs. This formula may comprise at least one of the following ingredients: from about 1% to about 90% animal digest, from about 1% to about 30% dried brewer's yeast, from about 0.1% to about 10% vitamin C, from about 0.1% to Petition 870260049983, dated 05 / 26 / 2026, page 24 / 71 19 / 26 approximately 10% vitamin E, approximately 0.01% to approximately 3% beta-carotene, approximately 0.1% to approximately 5% zinc proteinate, approximately 0.01% to approximately 3% manganese proteinate, approximately 0.01% to approximately 3% ferrous sulfate, approximately 0.01% to approximately 1% copper proteinate, approximately 0.01% to approximately 1% calcium iodate, and approximately 0.001% to approximately 0.1% sodium selenite. In an additional embodiment, the compositions further comprise approximately 0.1% to approximately 2% taurine, and approximately 1% to approximately 50% probiotics. The compositions may additionally comprise from about 0.01% to about 2% sodium chloride.

[0052] In another form, the compositions can be formulated for cats. This formula may comprise at least one of the following: from about 0% to about 80% animal digest, from about 0% to about 30% dried brewer's yeast, from about 0% to about 10% vitamin C, from about 0% to about 10% vitamin E, from about 0% to about 3% beta-carotene, from about 0% to about 5% zinc proteinate, from about 0% to about 2% taurine, from about 0% to about 3% manganese proteinate, from about 0% to about 3% ferrous sulfate, from about 0% to about 1% copper proteinate, from about 0% to about 0.1% calcium iodate, from about 0% to about 0.01% sodium selenite, and from about 1% to about 50% of probiotics. The compositions may additionally comprise from about 0.01% to about 2% sodium chloride.

[0053] Those skilled in the art can determine the appropriate amount of probiotics to be added to a given formulation. Factors that may be taken into account include the average consumption of specific types of compositions by different animals, and whether the animal intended to ingest the dietary supplements Petition 870260049983, dated 05 / 26 / 2026, page 25 / 71 20 / 26 has any specific health, welfare or nutritional requirements, or suffers from a specific disease or disorder, the animal's age, sex, size or breed, and the manufacturing conditions under which the composition is prepared. The concentrations of probiotics to be added to the composition can be calculated according to the animal's energy and nutrient requirements.

[0054] The probiotics, particularly the microencapsulated probiotics, in the composition remain substantially viable when the composition is stored for a period of 11 days at temperatures up to 50 °C, 2 days at temperatures up to 60 °C, or 20 hours at temperatures up to 65 °C.

[0055] Additionally, the composition may further comprise an antidiarrheal agent.

[0056] As discussed in this document, in various embodiments, the present compositions may be pet food compositions. In various embodiments, the pet food composition may be a wet food, a semi-moist food, or a dry food. In one embodiment, the pet food composition is one or more components of a mixed composition. In some embodiments, the pet food composition is a feed pellet, and in some embodiments, the pet food composition is a meat analogue.

[0057] The pet food compositions disclosed herein may be any food formulated for consumption by a canine or feline. In one embodiment, the pet food composition may be a complete and balanced pet food; that is, it provides complete nutrition as defined by the Association of American Feed Control Officials (AAFCO) for a canine or feline. Petition 870260049983, dated 05 / 26 / 2026, p. 26 / 71 21 / 26

[0058] For example, pet food may comprise meat, such as emulsified meat. Examples of suitable meats include poultry, beef, pork, lamb, and fish, especially those types of meat suitable for pets. Meat may include any additional parts of an animal, including offal. Some or all of the meats may be provided in the form of one or more meat meals, that is, meat that has been dried and ground to form substantially uniform particle sizes, as defined by AAFCO.Alternatively or as an additional option, vegetable protein can be used, such as pea protein, corn protein (e.g., ground corn or corn gluten), wheat protein (e.g., ground wheat or wheat gluten), soy protein (e.g., soy flour, soy concentrate or soy isolate), rice protein (e.g., ground rice or rice gluten) and the like.

[0059] The pet food compositions disclosed herein may comprise vegetable oil, a flavoring, a coloring, and water. Suitable vegetable oils include soybean oil, corn oil, cottonseed oil, sunflower oil, canola oil, peanut oil, safflower oil, and the like. Examples of suitable flavorings include yeast, tallow, rendered animal meals (e.g., poultry, beef, lamb, pork), flavoring extracts or blends (e.g., grilled beef), hydrolyzed animal-derived material, and the like. Suitable colorings include FD&C colors such as Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, and the like; natural colorants, such as caramel coloring, annatto, chlorophyllin, cochineal, betanin, turmeric, saffron, paprika, lycopene, elderberry juice, pandanus, butterfly pea and the like; titanium dioxide; and any Petition 870260049983, dated 05 / 26 / 2026, page 27 / 71 22 / 26 suitable food coloring known to those skilled in the art.

[0060] The pet food compositions disclosed herein may optionally include additional ingredients such as other grains and / or other starches, in addition to or alternatively to flour, amino acids, fiber, sugars, animal oils, flavorings, other oils in addition to or alternatively to vegetable oil, humectants, preservatives, polyols, salts, oral care ingredients, antioxidants, vitamins, minerals, probiotic microorganisms, bioactive molecules or combinations thereof.

[0061] Suitable starches include a grain, such as corn, rice, wheat, barley, oats, soybeans and the like, and mixtures of these grains, and may be included at least partially in any flour. Suitable humectants include salt, sugars, propylene glycol and polyhydric glycols, such as glycerin and sorbitol, and the like. Suitable oral care ingredients include alfalfa nutrient concentrate containing chlorophyll, sodium bicarbonate, phosphates (e.g., tricalcium phosphate, acid pyrophosphates, tetrasodium pyrophosphate, metaphosphates and orthophosphates), peppermint, cloves, parsley, ginger and the like. Examples of suitable antioxidants include butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT), vitamin E (tocopherols) and the like.

[0062] Non-limiting examples of vitamins that can be used include vitamins A, B complex (such as B-1, B-2, B-6 and B-12), C, D, E and K, niacin and acidic vitamins such as folic acid, and biotin. Non-limiting examples of suitable minerals include calcium, iron, zinc, magnesium, iodine, copper, phosphorus, manganese, potassium, chromium, molybdenum, selenium, nickel, tin, silicon, vanadium, boron and the like.

[0063] Non-limiting examples of suitable preservatives include potassium sorbate, sorbic acid, sodium methyl parahydroxybenzoate, calcium propionate, propionic acid, and combinations thereof. Petition 870260049983, dated 05 / 26 / 2026, page 28 / 71 23 / 26 same.

[0064] The specific quantities for each additional ingredient in the food compositions disclosed herein will depend on a variety of factors, such as the ingredient included in the first edible material and in any second edible material; the species of animal; the age, body weight, general health, sex and diet of the animal; the rate of consumption of the animal; the purpose for which the food product is administered to the animal; and the like. Examples

[0065] The following non-limiting examples are illustrative of embodiments of the present description. Example 1 - In vitro study

[0066] To simulate the effects on the large intestine, psyllium and psyllium / SF68® were evaluated in a canine and feline batch in vitro fermentation model. In vitro analysis: substrates were fermented for 0 and 12 hours with fecal inoculum obtained from multiple dogs or cats. Freshly emptied feces were collected from donor dogs and cats and immediately frozen at -80 °C and used to inoculate all substrate x time combinations in triplicate. Substrate-free tubes in triplicate were also fermented with each inoculum source and time point taking into account appropriate corrections not arising from the substrates themselves (e.g., blank block). Aliquots of a semi-defined medium, added to maintain microbial viability, were aseptically transferred to 50 mL tubes containing 300 mg of substrate.Anaerobic conditions were maintained by sealing the tubes with rubber stoppers equipped with one-way gas release valves. Fecal samples were pooled and then diluted 1:10 (w / v) in anaerobic dilution solution by mixing for 15 seconds in a Ninja mixer under a stream of CO2. The feces... Petition 870260049983, dated 05 / 26 / 2026, page 29 / 71 24 / 26 diluted and mixed solutions were filtered through 4 layers of gauze and sealed in 125 mL serum bottles under CO2. Aliquots of fecal inoculum were anaerobically injected into substrate + medium tubes and incubated for 12 hours, after which subsamples of each were taken for analysis. Measurements of pH, short-chain fatty acids, and targeted microbiota by qPCR (Bifidobacterium spp., Lactobacillus spp., C. perfringens) were corrected for blank tubes and time 0 hours. Microbiome analysis by Illumina 16S sequencing was not corrected for blank tubes, but rather compared to a time point at time 0 hours.

[0067] Results were obtained. The pH was decreased with the psyllium / SF68® combination compared to psyllium alone and the blank block, indicating microbial fermentation, SCFA and lactate production, and a more suitable environment for beneficial colonic bacteria. Lactobacillus spp. increased with both psyllium and psyllium / SF68® compared to the blank block. Bifidobacteria spp. increased with the psyllium / SF68® blend compared to the blank block and psyllium alone. Increases in Lactobacillus and Bifidobacterium spp. are indicative of good digestive health. Psyllium alone increased Clostridia perfringens compared to the blank block, but the psyllium / SF68® combination did not. C. perfringens is a pathogenic bacterium, and increases indicate the potential for poor digestive health. Based on Illumina 16S sequencing methodology, psyllium / SF68 fermentation led to a clear separation in bacterial patterns.LEfSE analysis showed that Faecalibacterium and Lactobacillus are more closely associated with the psyllium / SF68 blend in cats, while Lactobacillus, Bifidobacterium, and Faecalibacterium were more closely associated with the psyllium / SF68 blend in dogs. These bacteria are indicators of good digestive health. Overall, these results... Petition 870260049983, dated 05 / 26 / 2026, p. 30 / 71 Studies in vitro indicated that the psyllium / SF68® blend stimulates the growth of specific bacteria to support digestive health. Example 2 - In vivo study with dogs

[0068] A field study with Alaskan Huskies from several sled dog kennels in the Fairbanks, Alaska area, including the Nestlé Purina kennel facility in Salcha, Alaska, was conducted to test efficacy. In this study, dogs with identified acute diarrhea were supplemented with 1 of 5 treatments for 7 days, during which fecal scores were recorded by owners using a scale of 1 to 3. The treatments and components are shown in Table 1: Table 1 Treatment Animal Digest (g) SF68® (g) Egg Powder (g) Psyllium (g) 1. Control 0.78 2. SF68® 0.78 0.05 3. SF68® + Egg 0.78 0.05 1.0 4. SF68® + Psyllium 0.78 0.05 0.5 5. SF68® + Egg + Psyllium 0.78 0.05 1.0 0.5

[0069] On day 7, all treatments provided better fecal scores than the control. Additionally, complete resolution of diarrhea was studied for the treatments. Unexpectedly, treatment #4 provided the highest incidence of complete resolution. Notably, treatment #2 (SF68®) provided a higher incidence of complete resolution than the control, while treatment #3 (SF68® + egg powder) was even higher, and treatment #5 (SF68® + psyllium + egg powder) was even higher (more than #2 or #3). However, surprisingly, the highest incidence of complete resolution was achieved by treatment #4 (SF68® + psyllium). This was unexpected. Petition 870260049983, dated 05 / 26 / 2026, page 31 / 71 26 / 26 since egg powder showed an increased effect when paired with SF68®, and the addition of psyllium showed an even better result. Therefore, it was expected that removing the egg powder would reduce the incidence of complete resolution. This finding was neither expected nor predicted. The results are shown in Table 2. Table 2 Treatment Control SF68® SF68® + egg SF68® + egg + psyllium SF68® + psyllium Complete resolution (Average, with a score of 0 or 1) 0.39 0.45 0.55 0.59 0.64

[0070] Thus, in one embodiment, the present compositions may consist essentially of a probiotic and psyllium, the probiotic comprising at least one of any suitable strain or subspecies of Enterococcus. In one aspect, the compositions may consist of psyllium and the probiotic. In another aspect, the compositions may exclude egg powder.

[0071] It should be understood that various alterations and modifications to the present preferred embodiments described herein will be apparent to those skilled in the art. Such alterations and modifications may be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such alterations and modifications be covered by the appended claims.

Claims

1. Use of a probiotic and psyllium, characterized in that it is for the preparation of a pet food composition to improve the microbiome in dogs or cats, wherein the probiotic comprises at least one of any suitable strain or subspecies of Enterococcus, wherein the psyllium is present in the composition in an amount of 20% by weight to 80% by weight.

2. Use, according to claim 1, characterized in that each gram of the composition contains the probiotic in an amount of 10⁵ colony-forming units (CFU) to 10¹⁰ CFU.

3. Use according to claim 1, characterized in that the composition is administered to the animal regularly.

4. Use according to claim 1, characterized in that the composition is a dietary supplement.

5. Use according to claim 1, characterized in that the probiotic comprises Enterococcus faecium.

6. Use, according to claim 1, characterized in that the composition increases Lactobacillus and bifidobacteria.

7. Use, according to claim 1, characterized in that the composition reduces Clostridia perfringens.

8. Use, according to claim 1, characterized in that the composition improves digestive health, treats diarrhea, increases stool quality, or combinations thereof.

9. Use of a probiotic and psyllium, characterized by the fact that it is for the preparation of a pet food composition to treat or prevent gastrointestinal problems in dogs or cats, wherein the probiotic comprises at least one of any suitable strain or subspecies of Enterococcus, wherein the psyllium is present in the composition in an amount of 20% by weight to 80% by weight.

10. Use of a probiotic and psyllium, characterized in that it is for the preparation of a pet food composition to treat or prevent diarrhea, increase or improve fecal quality, and increase or improve digestive health in dogs or cats, wherein the probiotic comprises at least one of any suitable strain or subspecies of Enterococcus, wherein the psyllium is present in the composition in an amount of 20% by weight to 80% by weight.