Method and composition for modulating microbiomes and prevention of dysbiosis

Abstract

Methods and compositions for modulating a microbiome of a urogenital area or a skin area of a user are disclosed. The method can include applying a composition to a urogenital area or a skin area of a user, wherein the composition can include a carrier and a therapeutic agent. The therapeutic agent can include at least one prebiotic comprising at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, with or without a cyclic moiety. The at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises a highly branched cyclic dextrin, a β-limit dextrin, or a combination thereof. The method can further include promoting a healthy microflora balance of the urogenital area or the skin area of the user. Further disclosed is a composition for modulating a microbiome of a urogenital area or a skin area of a user, wherein the composition comprises a single liquid phase, the single liquid phase comprising an aqueous solution and a therapeutic agent. The therapeutic agent can include at least one prebiotic compound comprising at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, with or without a cyclic moiety, such as a highly branched cyclic dextrin, a β-limit dextrin, or a combination thereof. The disclosed methods and compositions for modulating a microbiome of a urogenital area or a skin area of a user help promote the growth of healthy Lactobacillus species to prevent dysbiosis and other related conditions and infections.

Description

[0001] 65124902US01 METHOD AND COMPOSITION FOR MODULATING MICROBIOMES AND PREVENTION OF DYSBIOSIS CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to the benefit of U.S. Provisional Application No.63 / 573,058, filed April 2, 2024, which is expressly incorporated herein by reference in its entirety. BACKGROUND OF THE DISCLOSURE Humans are colonized by microbes in the gastrointestinal tract, on the skin, and in other epithelial tissue niches such as the oral cavity, eye surface and vagina. Healthy microbial flora in these areas can comprise hundreds of different species of bacteria. A healthy microbial flora provides the host with multiple benefits, including colonization resistance to a broad spectrum of pathogens, essential nutrient biosynthesis and absorption, and immune stimulation. A marker of a healthy microbial flora is often the presence of known healthy Lactobacillus bacteria. Lactobacillus species are commonly found on outer of the body, such as skin, epithelium, and mucous membranes. The presence of Lactobacillus has been established to be important in the regulation of urogenital health, especially for women, as Lactobacillus species are common in the vagina and bladder. For example, a normal vagina generally contains more than about 104lactobacilli per milliliter of vaginal fluid. Under normal conditions, the vaginal flora provides a mildly acidic environment that helps against the invasion of pathogenic microbes. Unfortunately, the balance of the vaginal flora may be easily upset by a variety of external factors that ultimately lead to vaginal infection. Vaginal infections include, but are not limited to, bacterial vaginosis, candidal vaginitis ("yeast"), and trichomonas vaginitis ("trich"). Current treatment regimens for a bacterial infection of the vagina involve the use of various spectrum antibiotics, such as metronidazole. However, antibiotics are often undesirable because they may kill a broad range of the normal bacterial flora in the vagina, including the beneficial lactobacilli. This may cause secondary complications, because the lactobacilli help regulate various other opportunistic pathogens in the vagina. The treatment may then necessitate a further treatment regimen, such as the ingestion of cultured dairy products to replace the lactobacilli in the body, as well as treatment antifungal agents. Moreover, a rise in the level of anaerobes due to a lack of lactobacilli could further complicate the infection. Additionally, antibiotics, when used frequently within the vagina, may cause systemic toxicity through absorption from the vagina. 65124902US01 Likewise, dysbiosis in the normal bacterial flora in the bladder may be associated with urinary incontinence, overactive bladder symptoms, and urinary tract infections. Urinary incontinence (UI) and Overactive bladder (OAB) may cause a person to experience the sensation of the need to instantly urinate regardless of whether the bladder is full. Urinary tract infections (UTI) can be rather common infections, especially within women, and can cause painful and negative symptoms such as fever, pain or burning with urination, and the sensation to urinate often. Dysbiosis of the bladder microbiome is a global widespread problem. For instance, about 800 million people globally have UI, and of this 800 million people, 70% are female. Despite the large number of people with UI, there is a lack of sufficient long-term treatment. Various products exist to provide the ability to possibly lessen or manage incontinence symptoms without medical intervention, however, these products may involve insertion of various physical products or providing various stimulations near a person’s bladder. Further, current treatment regimens for UTIs involve the use of various broad-spectrum antibiotics, which can possibly kill the beneficial lactobacilli and prevent regulation of the microbiome of the bladder. However, if the healthy Lactobacillus bacteria could be supported, then the symptoms of UTIs, UI, and OAB may be reduced, or possibly prevented. Accordingly, a need exists for compositions and methods for modulating microbiomes, especially the microbiomes of the vagina, bladder, and other skin areas to improve urogenital health in a user. A need also exists for compositions and methods for preventing or treating incontinence, overactive bladder, urinary tract infections, bacterial vaginosis, candidal vaginitis, and trichomonas vaginitis in a user. SUMMARY OF THE DISCLOSURE It has now been surprisingly discovered that high molecular weight branched dextrins that may contain two or more α-1,6-glycosidic bonds, with or without a cyclic moiety, can help modulate a microbiome of a urogenital area or a skin area of a user by promoting the growth of certain commensal bacteria, such as lactobacilli, yet maintaining or hindering the growth of certain pathogenic bacteria, such as Escherichia coli. As such, it has been discovered that certain therapeutic agents which comprise at least one prebiotic compound, such as a high molecular weight branched dextrin with two α-1,6-glycosidic bonds, with or without a cyclic moiety, can be administered to a user to treat or prevent certain conditions of the urogenital area and the skin. The present disclosure is directed to a method and composition for modulating a microbiome of a urogenital area or a skin area of a user. In one aspect, a method for modulating a microbiome of urogenital areas or skin areas of a user is provided. The method can include applying a composition to urogenital 65124902US01 and / or skin areas of a user, the composition comprising a carrier and a therapeutic agent. The therapeutic agent, for instance, can comprise at least one prebiotic compound which includes at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds. The method can further include promoting a healthy microflora balance of the urogenital area or the skin area of the user. In one aspect, the prebiotic compound comprising at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a molecular weight of greater than about 25,000 kDas. The at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds may or may not have a cyclic moiety. In preferred embodiments, the at least one high molecular weight dextrin with two or more α-1,6- glycosidic bonds is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof. In one embodiment, the prebiotic compound comprises only a highly branched cyclic dextrin. In another embodiment, the prebiotic compound comprises only a β-limit dextrin. In a further embodiment, the prebiotic compound comprises a mixture of both a highly branched cyclic dextrin and a β-limit dextrin. The dextrin of the present disclosure may have a purity level of about 80% or greater, such as about 95% or greater, such as about 99% or greater. The method of the present disclosure can comprise applying a composition to urogenital and / or skin areas of a user. In some embodiments, a urogenital area of a user comprises the vaginal canal, vulva, vagina, urethra, urinary tract, bladder, and / or surrounding areas. In other embodiments, the skin area of the body comprises any outer surface of the body, including but not limited to skin, epithelium, mucous membranes, and any other tissue forming the outer layer of a body’s surface. In one embodiment, the composition has a pH from about 3 to about 6, such as from about 4 to about 5. To obtain the desired characteristics of the composition, including the pH, the composition, in other embodiments, may further comprise an additional prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and / or an antimicrobial agent. In alternative embodiments, the composition is in the form of a liquid, a gel, a cream, a spray, and / or a suppository. In further embodiments, the composition is free from an alcohol. In certain embodiments, the composition comprises a carrier and a therapeutic agent. The carrier, for instance, can comprise an aqueous solution and can be greater than about 90% wt / vol of the composition. The therapeutic agent, for instance, can comprise about 0.1% wt / vol to about 20% wt / vol of the composition. The method of the current disclosure may comprise promoting a healthy microflora balance of a urogenital area and / or a skin area of the user. Promoting the healthy microflora balance can comprise 65124902US01 promoting a growth of Lactobacillus bacteria relative to a growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof. For instance, the promotion of the healthy Lactobacillus species may be reported as a ratio of healthy bacteria growth to harmful bacteria growth. In certain embodiments, the ratio of the growth of Lactobacillus species the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1% wt / vol – 20% wt / vol of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, such as greater than about 2.5, such as greater than about 3.0, such as greater than about 3.5, and even greater than about 5.0. In alternative embodiments, the method of the present disclosure can further comprise applying the composition to a substrate. The substrate, for instance, can be a wipe or at least a portion of an absorbent article. In some embodiments, after application to the substrate, the ratio of growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1.5% wt / vol to about 8.5% of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about 1.25, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.5. In another aspect, a composition for modulating a microbiome of a urogenital area or a skin area of a user is provided. The composition, for instance, can comprise a single liquid phase. The single liquid can comprise an aqueous solution and a therapeutic agent. The therapeutic agent, for instance, can comprise at least one prebiotic compound which includes at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds. In certain embodiments, the composition is free from an alcohol. In further embodiments, the composition is not an emulsion. Notably, in certain embodiments, the composition does not contain any Other features and aspects of the present disclosure are discussed in greater detail below. BRIEF DESCRIPTION OF THE DRAWINGS A full and enabling disclosure of the present disclosure is set forth more particularly in the remainder of the specification, including reference to the accompanying figures, in which: 65124902US01 Figure 1 graphically illustrates the mean log CFU / mL change (Δ) in Lactobacillus crispatus KC18- 1173-1 and Escherichia coli KC16-7171-8 after exposure to 2% wt / vol prebiotic compounds in a competitive co-culture assay described in Example 3. Error bars represent standard error of the mean. Figure 2 graphically illustrates average log CFU / mL change (Δ) in Lactobacillus crispatus KC18- 1 and Escherichia coli KC17-4298-8 after exposure to 2% wt / vol prebiotic compounds in a competitive co-culture assay described in Example 3. Error bars represent standard error of the mean. Figure 3 graphically illustrates average log CFU / mL change (Δ) in Lactobacillus crispatus KC18- 1173-1 and Staphylococcus aureus KC17-4367-2 after exposure to 2% wt / vol prebiotic compounds in a competitive co-culture assay described in Example 3. Error bars represent standard error of the mean. Figure 4 graphically illustrates mean log CFU / mL change (Δ) in Lactobacillus crispatus KC18- 1173-1 and Streptococcus anginosus KC18-1131-3B after exposure to 2% wt / vol prebiotic compounds in a competitive co-culture assay described in Example 3. Error bars represent standard error of the mean. Figure 5 graphically illustrates mean percent (%) cell viability (MTT assay) of EPI-200 tissues exposure to different concentrations of highly branched cyclic dextrin (HBCD) as described in Example 5. Triton X-100 was used as a positive control to demonstrate decrease in cell viability and Milli- Q water was used as a negative control. Error bars represent standard deviation. Figure 6 graphically illustrates mean concentration (pg / mL) of IL-1α and IL-8 inflammatory markers after exposure of EPI-200 tissues to different concentrations of highly branched cyclic dextrin as described in Example 5. Triton X-100 was used as a positive control to demonstrate increase in IL-1α and IL-8 and Milli-Q water was used as a negative control. Error bars represent standard deviation. Repeat use of reference characters in the present specification and the drawings is intended to represent same or analogous features or elements of the invention. DEFINITIONS As used herein, the term “inhibit” generally means to reduce by a measurable amount or to prevent entirely. As used herein, the term “urogenital” refers to the vaginal canal, vulva, vagina, urethra, urinary tract, bladder, and surrounding areas. 65124902US01 As used herein, the term “skin” refers to epithelium, mucous membranes, and any other tissue forming the outer layer of a body’s surface. As used herein, the term “user” or “subject” refers to a person who is receiving the composition of the present disclosure. As used herein, the terms “effective amount” and “therapeutic amount” are an amount sufficient to inhibit, but not necessarily kill, pathogenic microorganisms that may be responsible for or lead to infection of the vagina or bladder. In fact, although not required, it may be desired to use a concentration that does not significantly affect or inhibit the growth characteristics of the normal vaginal or bladder flora or otherwise significantly irritate the vaginal or bladder tissue when used at inhibitory, noncytotoxic, or clinical concentrations. For example, a therapeutic agent can be desirably employed at a concentration of about 0.01% to about 20% wt / vol, in some embodiments from about 0.1% to about 10% wt / vol, in some embodiments from about 0.2% to about 7.5% wt / vol, and in some embodiments from about 0.5% to about 5.0% wt / vol. It should be understood that the dosage may vary with the age, condition, and microbiome of the site, and may be readily determined by one of skill in the art. As used herein, the term “therapeutic effect” refers to the ability of the compositions and methods of the present disclosure to stimulate the growth of Lactobacillus species relative to Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof measured according to the therapeutic effect protocol described below. The therapeutic effect can be expressed as a ratio of Lactobacillus species to Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof and is desirably greater than about 1, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, such as greater than about 2.5, such as greater than about 3, such as greater than about 3.5, and even greater than about 5. As used herein, the designation “% wt / vol” or “wt / vol” refers to the value obtained by dividing the weight of a substance (in grams) by the volume of the solution (in milliliters), and then multiplying by 100. As used herein the term "soluble" when having reference to a bladder therapeutic agent means that the substance is at least soluble according to the method described by L. Prosky et al, J. Assoc. Off. Anal. Chem.71, 1017-1023 (1988). DETAILED DESCRIPTION OF THE DISCLOSURE A method and composition for modulating a microbiome of a urogenital area or a skin area of a user is provided herein. The methods and compositions of the present disclosure are intended to stimulate the growth of Gram-positive rod-shaped bacteria belonging to the Lactobacillus species. It is 65124902US01 believed that stimulating the growth of, and dominance of, lactobacilli reestablish healthy flora by reducing or excluding the population of pathogenic bacteria. The compositions of the present disclosure generally comprise a therapeutic agent capable of facilitating the growth of Gram-positive rod-shaped bacteria belonging to the Lactobacillus species. Preferably the therapeutic agent of the composition comprises at least one prebiotic including at least one type of high molecular weight dextrin with two or more α-1,6- glycosidic bonds. Lactobacillus species promote a healthy intimate microenvironment through competitive exclusion of pathogens, production of hydrogen peroxide, production of bacteriocins, production of surfactants, and production of other antimicrobial products that prevent infection and train the immune system. Notably, lactobacilli produce lactic acid, which can help lower the vaginal pH. Further, lactic acid can also play a role in maintaining the skin barrier. Accordingly, the methods and compositions disclosed herein have broad applicability, and in some embodiments, could be applied anywhere lactobacilli are present. The method for modulating a microbiome of a urogenital area or a skin area of a user can include, in one embodiment, applying a composition to a urogenital area or a skin area of a user, wherein the composition comprises a carrier and a therapeutic agent, to promote a healthy microflora balance of the urogenital area or the skin area of a user. The carrier of the composition can include, for instance, a “dermatologically acceptable carrier”, which refers to a carrier that is suitable for topical application to epithelium and is compatible with the therapeutic agent. The dermatologically acceptable carrier may be in a wide variety of forms such as, for example, simple solutions (water-based or oil-based) and solid forms (e.g., gels or sticks). In some embodiments, the carrier can be either aqueous or non-aqueous. Non-aqueous carriers may include, for example, glycols, such as propylene glycol, butylene glycol, triethylene glycol, hexylene glycol, polyethylene glycols, ethoxydiglycol, and dipropyleneglycol; alcohols, such as ethanol, n-propanol, and isopropanol; triglycerides; ethyl acetate; acetone; triacetin; and combinations thereof. However, in some preferred embodiments, the non-aqueous carrier is not an alcohol such that the composition is free from an alcohol. In preferred embodiments, the carrier is an aqueous solution. For instance, water is a particularly preferred aqueous carrier, such that the dermatologically acceptable carrier is used as a water-based simple solution. In some embodiments, the carrier constitutes greater than about 75% wt / vol, more preferably greater than about 85% wt / vol, and still more preferably greater than about 90% wt / vol. In 65124902US01 other embodiments, the carrier can constitute greater than about 95% wt / vol, or greater than about 96% wt / vol, 97% wt / vol, 98% wt / vol, or even 99% wt / vol. Accordingly, in other embodiments, compositions of the present disclosure comprise less than about 20% wt / vol of the therapeutic agent. In some embodiments the total amount of therapeutic agent is less than about 15% wt / vol, such as less than about 10% wt / vol, such as less than about 7.5% wt / vol, and such as less than about 5% wt / vol. In some embodiments, the total amount of therapeutic agent may be about 0.01% to about 20% wt / vol, such as from about 0.1% to about 10% wt / vol, such as about 0.25% to about 5% wt / vol, such as about 0.5% to about 2% wt / vol. For instance, in one embodiment, the composition comprises from about 0.1% to about 2% wt / vol of a therapeutic agent comprising β-limit dextrin, highly branched cyclic dextrin, or mixtures thereof. The therapeutic agent can comprise at least one prebiotic compound including at least one high molecular weight dextrin. The dextrin can be branched, cyclic, and / or may contain two or more α-1,6- glycosidic bonds. Prebiotic compounds are most commonly plant fibers that are non-digestible food ingredients selectively used by healthy bacteria as a food source to promote their growth. Dextrins are a type of prebiotic compounds that are typically low-molecular weight carbohydrates produced by the hydrolysis of starch and glycogen, such that dextrins are mixtures of polymers of D-glucose units linked by α-1,4-glycosidic bonds and / or α-1,6-glycosidic bonds. Starch hydrolysis may be accomplished by heat, acids, or enzymes, or a combination thereof. Dextrins with high molecular weights have surprisingly been found to be effective prebiotic compounds for modulating a microbiome of a urogenital area or a skin area of a user by promoting the growth of certain commensal bacteria, such as lactobacilli, yet maintaining or hindering the growth of pathogenic bacteria. In certain embodiments, high molecular weight dextrins have a molecular weight of greater than about 25,000 kDa, such as greater than about 30,000 kDa, such as greater than about 100,000 kDa, such as greater than about 1,000,000 kDa, and even greater than about 3,000,000 kDa. In other embodiments, the high molecular weight dextrins have a molecular weight of less than about 30,000,000 kDa, such as less than about 10,000,000 kDa, such as less than about 5,000,000 kDa, and less than about 3,500,000 kDa. In one embodiment, the high molecular weight dextrin has a molecular weight of about 30,000 kDa to about 1,000,000 kDa. In another embodiment, the high molecular weight dextrin has a molecular weight of even greater than about 3,000,000 kDa. In preferred embodiments, the at least one high molecular weight dextrin has a molecular weight of about 25,000 kDa to about 10,000,000 kDa, such as from about 30,000 kDa to about 3,000,000 kDa. 65124902US01 In preferred embodiments, the therapeutic agent comprises at least one prebiotic including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds such that the at least one high molecular weight dextrin is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof. The number of branches in at least one high molecular weight dextrin has correlates to how many α-1,6- glycosidic bonds are present in the dextrin. Both highly branched cyclic dextrin and β-limit dextrin can be distinguished from other dextrins because they possess high molecular weights, they have narrow size distributions, and they have at least two α-1,6-glycosidic bonds. Moreover, these dextrins are produced via enzymatic hydrolysis of starch unlike more common approaches that utilize heat with or without an acid. In one embodiment of the present disclosure the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin. β-limit dextrin, for instance, is a highly branched α-glucan with a molecular weight of approximately 3,000,000 kDa comprised of a linear chain of α-1,4 D-glucose residues linked through α-1,6-glycosidic bonds and are derivatives of amylopectin. β-limit dextrins are formed, for instance, when β-amylase binds to every second α-1,4 glycosidic bond from the non-reducing end of starch polymers, cleaving sequential maltose units. However, as β-amylase cannot cleave α-1,6- glycosidic bonds, the β-limit dextrins contain all of the original branches (e.g., all of the original α-1,6- glycosidic bonds) of the starting starch molecules. In certain embodiments of the present disclosure, the β-limit dextrin can comprise at least 2 branches, such as at least 3 branches, such as at least 4 branches, such as at least 5 branches, such as at least 8 branches, such as at least 10 branches, and even such as at least 20 branches or more. In another embodiment of the present disclosure, the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a cyclic moiety and comprises only a highly branched cyclic dextrin. Highly branched cyclic dextrin, for instance, has a molecular weight between 30,000 kDa and 1,000,000 kDa and can comprise a cyclic moiety of D-glucose monomers joined together by α-1,4- glycosidic bonds with branching occurring through α-1,6-glycosidic bonds. In some instances, highly branched cyclic dextrin is produced from a starch source by enzymatic hydrolysis with α-amylase to produce clustered oligosaccharides of short linear α-1,4 glucose chains interlinked via α-1,6 bonds. Cyclization via intramolecular transglycosylation is carried out by 1,4-α-D-glucan branching enzyme, which links adjacent branched cluster via an α-1,6-glycosidic bond. Highly branched cyclic dextrins, in certain embodiments, can also have at least two α-1,6-glycosidic bonds and can be produced from amylopectin via a cyclization reaction of a branching enzyme. Exemplary commercially available highly 65124902US01 branched cyclic dextrin is CLUSTER DEXTRIN™, available from Ezaki Glico Co., Ltd., Nishiyodogawa Ward, Osaka, Japan. In other embodiments of the present disclosure, the highly branched cyclic dextrin can comprise at least 5 branches, such as at least 7 branches, such as at least 8 branches, such as at least 10 branches, and less than 50 branches, such as less than 40 branches, such as less than 30 branches, and such as less than 20 branches. The high molecular weight dextrin with two or more α-1,6-glycosidic bonds used as part of the therapeutic agent can have unexpectedly high levels of purity. In one embodiment, for instance, the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a purity level of about 80% or greater, such as about 92.5% or greater, such as about 95% or greater, such as about 97.5% or greater, such as about 99% or greater. Furthermore, purified dextrin forms contain less than 5% of monosaccharides, such as single glucose molecules. The high molecular weight dextrin with two or more α-1,6-glycosidic bonds, with or without a cyclic moiety that links adjacent branched cluster via an α-1,6-glycosidic bond, has been found to have enhanced effects on promoting the growth of healthy Lactobacillus bacteria. Without intending to be limited by theory, the present inventors have found that the presence of at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds helps to promote a healthy microflora balance of a urogenital area or a skin area of a user. The present inventors have found that the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds displays many unique characteristics that makes its effect on promoting a growth of Lactobacillus species relative to a growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof unexpected. For instance, the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds display narrow size distributions and molecular weights of greater than about 25,000 kDa. Further, the high molecular weight dextrins with two or more α-1,6-glycosidic bonds, in certain embodiments, are produced via enzymatic hydrolysis, compared to the more common approaches which utilize heat or acid, which can have other adverse effects on the at least one high molecular weight dextrin. Further, the high purity levels of the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds also display other chemical and economical advantages, as it allows less product to be used to achieve a therapeutic amount. In certain embodiments, for instance, the composition yields a therapeutic effect (a ratio of the growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof) after exposure to about 1% 65124902US01 wt / vol – 20% wt / vol of the composition in a 48-hour competitive co-culture assay in a urogenital area or a skin are of a user greater than about 1, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, such as greater than about 2.5, such as greater than about 3, such as greater than about 3.5, such as greater than about 4.0, such as greater than about 4.5, such as greater than about 5, and even greater than about 5.5. In some embodiments, a therapeutic effect of greater than about 1.5 is demonstrated even when the pathogenic bacteria are exposed to only about 2% wt / vol of the composition, which is a relatively low amount. Thus, without intending to be limited by theory, even small amounts of the therapeutic agent(s) may promote a healthy microflora balance of a urogenital area or a skin area of a user, and the ability to have a demonstrated therapeutic effect even when minimal amounts of the composition are utilized may provide not only various wellness and health related benefits to a user, but also economic benefits. Further, in other embodiments, a therapeutic effect of greater than about 2.5 can be achieved, such as when the pathogenic bacteria are exposed to about 20% wt / vol of the composition. For instance, in certain embodiments, a therapeutic effect of greater than 5.5 can be achieved when the pathogenic bacteria are exposed to about 20% wt / vol of the composition. Accordingly, the composition can be applied to any urogenital surface or skin surface to promote growth of healthy bacteria and to modulate a balanced microbiome. In certain embodiments, the methods and compositions disclosed herein can improve overall skin health and maintenance of the skin barrier by increasing the production of lactic acid, and can be applied to any skin surface including, but not limited to, epithelium, mucous membranes, and any other tissue forming the outer layer of a body’s surface. In preferred embodiments, the methods and compositions can improve urogenital health, and can be applied to any urogenital surface including, but not limited to, the vaginal canal, vulva, vagina, urethra, urinary tract, bladder, and surrounding areas. Such methods and compounds may be considered for the maintenance of vaginal and bladder health, the promotion of balanced intimate skin, the promotion of urinary tract health, and the prevention of bacterial vaginosis, yeast infections, urinary tract infections, incontinence, overactive bladder, pre-term labor, infertility, and other bacterial infections relevant to intimate wellness. In other embodiments, such methods and compounds disclosed herein may be associated with cosmetic endpoints including healthy discharge, less itching, and reduction of vaginal malodor. In other embodiments of the present disclosure, a composition for modulating a microbiome of a urogenital area or a skin area of a user is disclosed. The composition, for instance, comprises a single liquid phase, such that the single liquid phase comprises an aqueous solution and a therapeutic agent. 65124902US01 The therapeutic agent comprises at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds. In preferred embodiments, the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof. In one embodiment of the present disclosure, the at least one dextrin with two or more α-1,6-glycosidic bonds comprises only a highly branched cyclic dextrin. In another embodiment of the present disclosure, the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin. In certain embodiments, the single liquid phase of the composition comprises an aqueous solution. Water, for instance, is a particularly preferred aqueous carrier. In preferred embodiments, the single liquid phase of the composition does not include an alcohol, such that the composition is free from an alcohol. In one particular embodiment of the present disclosure, the composition is not an emulsion. In another particular embodiment of the present disclosure, the composition does not contain any probiotics. Probiotics, for instance, are live microorganisms, such as bacteria and yeast, that are intended to maintain or improve the healthy bacteria in the body. Probiotics differ from prebiotics because probiotics encompass the bacteria themselves, whereas prebiotics are merely food sources for the bacteria. Therefore, while probiotics include living microorganisms, prebiotics do not. Without intending to be limited by theory, the present inventors have surprisingly found that by using a therapeutic agent comprising at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, that a therapeutic effect can occur even without the use of any probiotics in the composition. The compositions of the present disclosure can be administered in several forms to a user. For example, compositions may be prepared as formulations for administration to a user or may be applied to a substrate, such as a wiping substrate, for administration to a user. Preferably the therapeutic agents useful in the present disclosure are soluble to facilitate their formulation for administration to a user. In certain embodiments, the compositions can be configured to be administered to a user through topical application in various forms, including, but not limited to, a liquid, cream, gel, spray, or suppository. In further embodiments, the composition can be formulated as a treatment formulation, such that it may be formulated as a moisturizer, lotion, jelly, liniment, ointment, salve, oil, foam, film, wash, slow-releasing polymer, coating, liquid, vaginal capsule, vaginal tablet, vaginal film, vaginal sponge, vaginal ovule, etc. The composition may also be applied to a vaginal insert, tampon, wipe or pad, and then administered to the vagina. 65124902US01 In other embodiments, the composition may include other components such as, for example, an additional prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and an antimicrobial agent. Additional Prebiotics In some embodiments, the composition can include one or more additional prebiotics that are different than the at least one high molecular weight dextrin of the present disclosure. The additional prebiotics may have a synergistic effect in combination with the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds. Suitable additional prebiotics can be selected from a group comprising α-D-lactose, maltitol, N-acetylglucosamine, α-cyclodextrin, β-cyclodextrin, glucomannan, D- tagatose, 2-deoxy-D-ribose, α-methyl-D-glucoside, amylopectin, β-D-fructose, β-D-glucose, D- arabinose, D-cellobiose, dextran, dextrin type I, dextrin type II, malate, D-trehalose, 4-O-β-D- galactopyranosyl-D-glucitol, lactitol, lactulose, maltotriose, isomaltulose, pectin, pullulan, salicin, and xylitol. Surfactants In some embodiments, the composition can include one or more surfactants. In an embodiment where the composition is included in a wipe, the composition may also likely include one or more surfactants. These may be selected from anionic, cationic, nonionic, zwitterionic, and amphoteric surfactants. Amounts of surfactants may range from 0.01% to 30%, or from 10% to 30%, or from 0.05% to 20%, or from 0.10% to 15% by total weight of the composition. In some embodiments, such as when the wetting composition is used with a wipe, the surfactant can comprise less than 5% by total weight of the wetting composition. Suitable anionic surfactants include, but are not limited to, C8to C22alkane sulfates, ether sulfates and sulfonates. Among the suitable sulfonates are primary C8to C22alkane sulfonate, primary C8to C22alkane disulfonate, C8to C22alkene sulfonate, C8to C22hydroxyalkane sulfonate or alkyl glyceryl ether sulfonate. Specific examples of anionic surfactants include ammonium lauryl sulfate, ammonium laureth sulfate, triethylamine lauryl sulfate, triethylamine laureth sulfate, triethanolamine lauryl sulfate, triethanolamine laureth sulfate, monoethanolamine lauryl sulfate, monoethanolamine laureth sulfate, diethanolamine lauryl sulfate, diethanolamine laureth sulfate, lauric monoglyceride sodium sulfate, sodium lauryl sulfate, sodium laureth sulfate, potassium laureth sulfate, sodium lauryl sarcosinate, sodium lauroyl sarcosinate, potassium lauryl sulfate, sodium trideceth sulfate, sodium methyl lauroyl taurate, sodium lauroyl isethionate, sodium laureth sulfosuccinate, sodium lauroyl sulfosuccinate, sodium tridecyl benzene sulfonate, sodium dodecyl benzene sulfonate, sodium lauryl amphoacetate and mixtures thereof. Other anionic surfactants include the C8to C22acyl glycinate salts. Suitable glycinate 65124902US01 salts include sodium cocoylglycinate, potassium cocoylglycinate, sodium lauroylglycinate, potassium lauroylglycinate, sodium myristoylglycinate, potassium myristoylglycinate, sodium palmitoylglycinate, potassium palmitoylglycinate, sodium stearoylglycinate, potassium stearoylglycinate, ammonium cocoylglycinate and mixtures thereof. Cationic counter-ions to form the salt of the glycinate may be selected from sodium, potassium, ammonium, alkanolammonium and mixtures of these cations. Suitable cationic surfactants include, but are not limited to alkyl dimethylamines, alkyl amidopropylamines, alkyl imidazoline derivatives, quaternised amine ethoxylates, and quaternary ammonium compounds. Suitable nonionic surfactants include, but are not limited to, alcohols, acids, amides or alkyl phenols reacted with alkylene oxides, especially ethylene oxide either alone or with propylene oxide. Specific nonionics are C6to C22alkyl phenols-ethylene oxide condensates, the condensation products of C8to C13aliphatic primary or secondary linear or branched alcohols with ethylene oxide, and products made by condensation of ethylene oxide with the reaction products of propylene oxide and ethylenediamine. Other nonionics include long chain tertiary amine oxides, long chain tertiary phosphine oxides and dialkyl sulphoxides, alkyl polysaccharides, amine oxides, block copolymers, castor oil ethoxylates, ceto-oleyl alcohol ethoxylates, ceto-stearyl alcohol ethoxylates, decyl alcohol ethoxylates, dinonyl phenol ethoxylates, dodecyl phenol ethoxylates, end-capped ethoxylates, ether amine derivatives, ethoxylated alkanolamides, ethylene glycol esters, fatty acid alkanolamides, fatty alcohol alkoxylates, lauryl alcohol ethoxylates, mono-branched alcohol ethoxylates, natural alcohol ethoxylates, nonyl phenol ethoxylates, octyl phenol ethoxylates, oleyl amine ethoxylates, random copolymer alkoxylates, sorbitan ester ethoxylates, stearic acid ethoxylates, stearyl amine ethoxylates, synthetic alcohol ethoxylates, tall oil fatty acid ethoxylates, tallow amine ethoxylates and tridecanol ethoxylates. Suitable zwitterionic surfactants include, for example, alkyl amine oxides, alkyl hydroxysultaines, silicone amine oxides, and combinations thereof. Specific examples of suitable zwitterionic surfactants include, for example, 4-[N,N-di(2-hydroxyethyl)-N-octadecylammonio]-butane-1-carboxylate, S-[S-3- hydroxypropyl-S-hexadecylsulfonio]-3-hydroxypentane-1-sulfate, 3-[P,P-diethyl-P-3,6,9- trioxatetradexopcylphosphonio]-2-hydroxypropane-1-phosphate, 3-[N,N-dipropyl-N-3-dodecoxy-2- hydroxypropylammonio]-propane-1-phosphonate, 3-(N,N-dimethyl-N-hexadecylammonio)propane-1- sulfonate, 3-(N,N-dimethyl-N-hexadecylammonio)-2-hydroxypropane-1-sulfonate, 4-[N,N-di(2- hydroxyethyl)-N-(2-hydroxydodecyl)ammonio]-butane-1-carboxylate, 3-[S-ethyl-S-(3-dodecoxy-2- hydroxypropyl)sulfonio]-propane-1-phosphate, 3-[P,P-dimethyl-P-dodecylphosphonio]-propane-1- phosphonate, 5-[N,N-di(3-hydroxypropyl)-N-hexadecylammonio]-2-hydroxy-pentane-1-sulfate, lauryl hydroxysultaine and combinations thereof. 65124902US01 Suitable amphoteric surfactants include, but are not limited to, derivatives of aliphatic quaternary ammonium, phosphonium, and sulfonium compounds, in which the aliphatic radicals can be straight or branched chain, and wherein one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one substituent contains an anionic group (e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate). Illustrative amphoterics are coco dimethyl carboxymethyl betaine, cocoamidopropyl betaine, cocobetaine, oleyl betaine, cetyl dimethyl carboxymethyl betaine, lauryl bis-(2-hydroxyethyl) carboxymethyl betaine, stearyl bis-(2-hydroxypropyl) carboxymethyl betaine, oleyl dimethyl gamma- carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alpha-carboxyethyl betaine, cocoamphoacetates, and combinations thereof. The sulfobetaines may include stearyl dimethyl sulfopropyl betaine, lauryl dimethyl sulfoethyl betaine, lauryl bis-(2-hydroxyethyl) sulfopropyl betaine and combinations thereof. Esters In some embodiments, the compositions include one or more esters. The esters may be selected from cetyl palmitate, stearyl palmitate, cetyl stearate, isopropyl laurate, isopropyl myristate, isopropyl palmitate, and combinations thereof. The fatty alcohols include octyldodecanol, lauryl, myristyl, cetyl, stearyl, behenyl alcohol, and combinations thereof. The fatty acids can include, but are not limited to, capric acid, undecylenic acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, arachidic acid, and behenic acid. Ethers such as eucalyptol, ceteraryl glucoside, dimethyl isosorbic polyglyceryl-3 cetyl ether, polyglyceryl-3 decyltetradecanol, propylene glycol myristyl ether, and combinations thereof can also suitably be used as emollients. Other suitable ester compounds for use in the antimicrobial compositions or the present disclosure are listed in the International Cosmetic Ingredient Dictionary and Handbook, 11th Edition, CTFA, (January, 2006) ISBN-10: 1882621360, ISBN-13: 978- 1882621361, and in the 2007 Cosmetic Bench Reference, Allured Pub. Corporation (July 15, 2007) ISBN- 10: 1932633278, ISBN-13: 978-1932633276, both of which are incorporated by reference herein to the extent they are consistent herewith. Humectants In some embodiments, the compositions include one or more humectants. Humectants that are suitable as carriers in the compositions of the present disclosure include, for example, glycerin, glycerin derivatives, hyaluronic acid, hyaluronic acid derivatives, betaine, betaine derivatives, amino acids, amino acid derivatives, glycosaminoglycans, glycols, polyols, sugars, sugar alcohols, hydrogenated starch hydrolysates, hydroxy acids, hydroxy acid derivatives, salts of PCA and the like, and combinations thereof. Specific examples of suitable humectants include honey, sorbitol, hyaluronic acid, sodium hyaluronate, betaine, lactic acid, citric acid, sodium citrate, glycolic acid, sodium glycolate, sodium lactate, urea, propylene glycol, butylene glycol, pentylene glycol, ethoxydiglycol, methyl gluceth-10, methyl 65124902US01 gluceth-20, polyethylene glycols (as listed in the International Cosmetic Ingredient Dictionary and Handbook such as PEG-2 through PEG 10), propanediol, xylitol, maltitol, or combinations thereof. The compositions of the disclosure may include one or more humectants in an amount of about 0.01% (by total weight of the composition) to about 20% (by total weight of the composition), or about (by total weight of the composition) to about 10% by total weight of the composition), or about 0.1% (by total weight of the composition) to about 5.0% (by total weight of the composition). pH Adjusting Agents In some embodiments, the compositions of the present disclosure can be acidic, i.e., have a pH less than about 7.0 and more preferably less than about 6.0, such as from about 3.0 to about 6.0 and still preferably from about 4.0 to about 5.0. In a particularly preferred embodiment, the pH may be maintained at a mildly acidic level to correspond to normal vaginal conditions, the environment in which the composition will typically be delivered. For example, the pH may be within a range of from about 3.0 to about 6.0, in some embodiments from about 3.5 to about 5.0, and in some embodiments, from about 4.0 to about 4.5. The foregoing acid pH may also provide other benefits. For instance, when the is configured to form a gel, such as described below, a low pH level may also improve the gelation rate and gel strength to reduce the likelihood of leakage just after insertion of the composition into the vagina. The pH of the composition may be adjusted using an organic acid. Organic acids useful in the present disclosure generally consist of mono- or polycarboxylic acids having one or more hydroxyl groups at least one of which is introduced into the α-position (i.e., on the carbon atom adjacent to the carboxyl functional group). Examples of particularly useful organic acids can include citric acid, lactic acid, methyllactic acid, phenyllactic acid, malic acid, mandelic acid, glycolic acid, tartronic acid, tartaric acid and gluconic acid. In particularly preferred embodiments the organic acid is selected from the group consisting of citric acid, lactic acid, malic acid, glycolic acid, and tartaric acid. In certain the organic acid may be provided with an appropriate counterion, such as calcium, sodium, or magnesium. In view of the foregoing, in certain embodiments the compositions and formulations of the present disclosure may have a pH from about 3.0 to about 6.0, more preferably from about 3.5 to about 5.0, and comprise a therapeutic agent comprising at least one prebiotic compound including at least one high weight dextrin with two or more 1,6-glycosidic bonds, wherein the total amount of therapeutic agent is from about 0.1% to about 2% wt / vol. Rheology Modifiers 65124902US01 Optionally, one or more rheology modifiers, such as thickeners, may be added to the composition. Suitable rheology modifiers are compatible with the therapeutic agent. As used herein, “compatible” refers to a compound that, when mixed with the therapeutic agent, does not adversely affect the properties of the therapeutic agent. A thickening system is used in the compositions to adjust the viscosity and stability of the compositions. Specifically, thickening systems prevent the composition from running off of the hands or body during dispensing and use of the composition. When the composition is used with a wipe product, a thicker formulation can be used to prevent the composition from migrating from the wipe substrate. The thickening system should be compatible with the compounds used in the present disclosure; that is, the thickening system, when used in combination with the therapeutic agent, should not precipitate out, form a coacervate, or prevent a user from perceiving the conditioning benefit (or other desired benefit) to be gained from the composition. The thickening system may include a thickener which can provide both the thickening effect desired from the thickening system and a conditioning effect to the user. Thickeners may include, cellulosics, gums, acrylates, starches, and various polymers. Suitable examples include but are not limited to hydroxyethyl cellulose, xanthan gum, guar gum, potato starch, and corn starch. In some embodiments, PEG-150 stearate, PEG-150 distearate, PEG-175 diisostearate, polyglyceryl-10 behenate / eicosadioate, disteareth-100 IPDI, polyacrylamidomethylpropane sulfonic acid, butylated PVP, and combinations thereof may be suitable. While the viscosity of the compositions will typically depend on the thickener used and the other components of the compositions, the thickeners of the compositions suitably provide for a composition having a viscosity in the range of greater than 1 cP to about 30,000 cP or more. In another embodiment, the thickeners provide compositions having a viscosity of from about 100 cP to about 20,000 cP. In yet another embodiment, thickeners provide compositions having a viscosity of from about 200 cP to about 15,000 cP. In embodiments where the compositions are included in a wipe, the viscosity may range from about 1 cP to about 2000 cP. In some embodiments, it is preferable to have a viscosity of the composition be less than 500 cP. When including a thickening system, the compositions of the present disclosure can include the thickening system in an amount of no more than about 20% (by total weight of the composition), or from about 0.01% (by total weight of the composition) to about 20% (by total weight of the composition). In another aspect the thickening system is present in the antimicrobial composition in an amount of from about 0.10% (by total weight of the composition) to about 10% (by total weight of the composition), or 65124902US01 from about 0.25% (by total weight of the composition) to about 5% (by total weight of the composition), or from about 0.5% (by total weight of the composition) to about 2% (by total weight of the composition). In one embodiment, the compositions may include hydrophobic and hydrophilic ingredients, such as a lotion or cream. Generally, these emulsions have a dispersed phase and a continuous phase and are generally formed with the addition of a surfactant or a combination of surfactants with varying hydrophilic / lipophilic balances (HLB). Suitable emulsifiers include surfactants having HLB values from 0 to 20, or from 2 to 18. Suitable non-limiting examples include Ceteareth-20, Cetearyl Glucoside, Ceteth- 10, Ceteth-2, Ceteth-20, Cocamide MEA, Glyceryl Laurate, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Stearate, Glyceryl Stearate SE, Glycol Distearate, Glycol Stearate, Isosteareth-20, Laureth-23, Laureth-4, lecithin, Methyl Glucose Sesquistearate, Oleth-10, Oleth-2, Oleth-20, PEG-100 Stearate, PEG-20 Almond Glycerides, PEG-20 Methyl Glucose Sesquistearate, PEG-25 Hydrogenated Castor Oil, PEG-30 Dipolyhydroxystearate, PEG-4 Dilaurate, PEG-40 Sorbitan Peroleate, PEG-60 Almond Glycerides, PEG-7 Olivate, PEG-7 Glyceryl Cocoate, PEG-8 Dioleate, PEG-8 Laurate, PEG-8 Oleate, PEG-80 Sorbitan Laurate, Polysorbate 20, Polysorbate 60, Polysorbate 80, Polysorbate 85, Propylene Glycol Isostearate, Sorbitan Isostearate, Sorbitan Laurate, Sorbitan Monostearate, Sorbitan Oleate, Sorbitan Sesquioleate, Sorbitan Stearate, Sorbitan Trioleate, Stearamide MEA, Steareth-100, Steareth- 2, Steareth-20, Steareth-21. The compositions can further include surfactants or combinations of surfactants that create liquid crystalline networks or liposomal networks. Suitable non-limiting examples include OLIVEM 1000 (INCI: Cetearyl Olivate (and) Sorbitan Olivate (available from HallStar Company (Chicago, IL)); ARLACEL LC (INCI: Sorbitan Stearate (and) Sorbityl Laurate, commercially available from Croda (Edison, NJ)); CRYSTALCAST MM (INCI: Beta Sitosterol (and) Sucrose Stearate (and) Sucrose Distearate (and) Cetyl Alcohol (and) Stearyl Alcohol, commercially available from MMP Inc. (South Plainfield, NJ)); UNIOX CRISTAL (INCI: Cetearyl Alcohol (and) Polysorbate 60 (and) Cetearyl Glucoside, commercially available from Chemyunion (Sào Paulo, Brazil)). Other suitable emulsifiers include lecithin, hydrogenated lecithin, lysolecithin, phosphatidylcholine, phospholipids, and combinations thereof. Gelling Agents In some embodiments in which the composition is in the form of a gel, the disperse phase of the gel may be formed from any of a variety of different gelling agents, including temperature responsive (“thermogelling”) compounds, ion responsive compounds, and so forth. Thermogelling systems, for instance, respond to a change in temperature (e.g., increase in temperature) by changing from a liquid to a gel. Generally speaking, the temperature range of interest is from about 25°C to about 40°C, in some embodiments from about 35°C to about 39°C, and in one particular embodiment, at the human body temperature (about 37°C). In some cases, thermogelling block copolymers, graft copolymers, and / or 65124902US01 homopolymers may be employed. For example, polyoxyalkylene block copolymers may be used in some embodiments of the present invention to form a thermogelling composition. Suitable thermogelling compositions may include, for example, homopolymers, such as poly(N-methyl-N-n-propylacrylamide), poly(N-n-propylacrylamide), poly(N-methyl-N-isopropylacrylamide), poly(N-n-propylmethacrylamide), poly(N-isopropylacrylamide), poly(N,n-diethylacrylamide); poly(N-isopropylmethacrylamide), poly(N- cyclopropylacrylamide), poly(N-ethylmethyacrylamide), poly(N-methyl-N-ethylacrylamide), poly(N- cyclopropylmethacrylamide), and poly(N-ethylacrylamide). Still other examples of suitable thermogelling polymers may include cellulose ether derivatives, such as hydroxypropyl cellulose, methyl cellulose, hydroxypropylmethyl cellulose, and ethylhydroxyethyl cellulose. Moreover, thermogelling polymers may be made by preparing copolymers between (among) monomers, or by combining such homopolymers with other water-soluble polymers, such as acrylic monomers (e.g., acrylic or methacrylic acid, acrylate or methacrylate, acrylamide or methacrylamide, and derivatives thereof). In one particular embodiment of the present disclosure, for example, the composition is configured to rapidly form a gel when applied to the vagina. A “gel” is a colloid in which a disperse phase combines with a dispersion medium to produce a jelly-like, solid, or semi-solid material. The gel may form in less than about one hour, in some embodiments less than about one minute, and in some embodiments, less than about 30 seconds. Among other things, such rapid gelation reduces the likelihood of leakage during use. In addition, because the gel may form intravaginally, it is more likely to retain its structure and shape over an extended period of time. In this manner, the gel may provide the prolonged release of a therapeutic agent that inhibits and / or treats vaginal infection. For instance, the gel may remain within the vagina for about 2 to about 48 hours to provide the desired effect to modulate the bladder microbiome of the user. Although a variety of compounds may be employed, water is usually employed as the dispersion medium for the gel to optimize biocompatibility. Other possible dispersion mediums include non-aqueous solvents, including glycols, such as propylene glycol, butylene glycol, triethylene glycol, hexylene glycol, polyethylene glycols, ethoxydiglycol, and dipropyleneglycol; alcohols, such as ethanol, n-propanol, and isopropanol; triglycerides; ethyl acetate; acetone; triacetin; and combinations thereof. Typically, the dispersion medium (e.g., water) constitutes greater than about 75% wt / vol, in some embodiments greater than about 90% wt / vol, and in some embodiments, from about 95% to about 99% wt / vol of the composition. The compositions of the present disclosure may also include an ion responsive compound. Such compounds are generally well known in the art and tend to form a gel in the presence of certain ions or at a certain pH. For instance, one suitable class of ion responsive compounds that may be employed in 65124902US01 the present disclosure is anionic polysaccharides. Anionic polysaccharides may form a three-dimensional polymer network that functions as the disperse phase of the gel. Generally speaking, anionic polysaccharides include polysaccharides having an overall anionic charge, as well as neutral polysaccharides that contain anionic functional groups. Any of a variety of anionic polysaccharides capable of forming a gel when contacted with vaginal mucosa may be used in the present disclosure. Such gel-forming anionic polysaccharides are typically stable over the normal acidic pH values found in the vagina (e.g., from about 2.5 to about 5.5). For instance, some suitable examples of gel-forming anionic polysaccharides include natural gums, such as gellan gum and alginate gums (e.g., ammonium and alkali metal of salts of alginic acid); chitosan; carboxymethylcellulose, pectins, carrageenan, xanthan gum, and derivatives or salts thereof. The particular type of anionic polysaccharide selected will depend, in part, on the nature of the composition and the other components used therein. For example, carrageenan is sensitive to particular types of cations, e.g., it typically gels in the presence of potassium but not sodium. Glycuronans, likewise, typically gel in the presence of divalent cations (e.g., Ca2+), but not monovalent cations (e.g., Na+). Xanthan gum may gel in the presence of divalent cations, but only at a relatively high pH. Although any of the above-described anionic polysaccharides may be used in the present disclosure, gellan gum is particularly desired for use in the present disclosure, either alone or in combination with other gelling agents, because it is able to form a gel in the presence of a wide variety of different cations, including both monovalent and divalent cations. Gellan gum is intended to encompass any form of gellan, including native gellan, clarified gellan, deacylated gellan, nonacylated gellan (e.g., produced from genetically engineered bacteria), clarified gellan (the polysaccharide is fully or partially removed from the bacterial debris), chemically modified gellan, etc. Various types of gellan gums and methods for forming such gums are described in U.S. Pat. Nos. 4,326,052, 4,326,053, 4,377,636, 4,385,123, and 4,563,366. Suitable gellan gums are commercially available from a variety of different sources. For example, GELRITE™ gellan gum is available from Sigma-Aldrich Chemical Co. of St. Louis, MO, and is produced from a naturally occurring polysaccharide after deacylation and clarification. Deacylated gellan is also available from CP Kelco U.S., Inc. of Chicago, IL under the name KELCOGEL®. Gellan gum may be either high or low acyl gellan. In the high acyl (or “native”) form, two acyl substituents, acetate and glycerate, are present. Both substituents are located on the same glucose residue, and, on average, there is one glycerate per repeat unit and one acetate per every two repeat units. In the low acyl form, the acyl groups may be wholly or partially removed through deacylation. The degree of deacylation of deacylated gellan gums may be at least about 20%, in some embodiments at least about 50%, and in some embodiments, at least about 75%. Alternatively, the low acyl gellan gum 65124902US01 may simply be “nonacylated” in that it is formed without acyl groups by genetically engineered bacteria. Regardless of the manner in which they are formed, low acyl gellan gums generally have a gelation temperature within the range 30°C to 50°C, which may be particularly well suited for use in the present disclosure so that it may gel at body temperatures of about 37°C, but remain stable at typical storage and transportation temperatures of about 25°C. In addition, low acyl gellan gums are also firm and elastic, and thus may retain their shape after delivery to the vaginal cavity. In most embodiments the gelling agent(s) are present in an amount of from about 0.01% to about 10.0% wt / vol, in some embodiments from about 0.05% to about 5.0% wt / vol, and in some embodiments, from about 0.1% to about 1.0% wt / vol of the composition. If desired, a gelling composition may be provided in any desired form (e.g., liquid, powder, etc.). In fact, one particular benefit of the composition is that it may be administered as a liquid, which allows for the selection of a wider variety of administration techniques than would otherwise be available for a solid or semi-solid gel. One technique that may be employed includes dispensing the composition through a liquid applicator, such as a syringe or tube, into the vaginal cavity. The administered volume of the composition may constitute a single dose or two or more doses. Although not necessarily required, the composition may also be sterilized prior to administration. Sterilization may be accomplished by any technique known in the art, such as using a gas (e.g., ethylene oxide), radiation (e.g., gamma), or heat (autoclaving). If desired, the composition may be subjected to one or more filtration steps prior to sterilization to help remove contaminants. Nitrogen Sources In some embodiments, the composition may include one or more nitrogen sources to drive potential synergies. Some suitable nitrogen sources include nitrogen heterocycles, ammonia, ammonium, urea, and amino acids. Suitable amino acids include, but are not limited to, slowly assimilated amino acids such as proline, which are often included to promote fermentation and encourage high productivity of secondary metabolites. Other suitable nitrogen sources include alloxan, ammonium citrate, glycine, L-cysteine, L-glutamic acid, L-glutamine, L-homoserine, L-leucine, L-lysine, L-methionine, L- tyrosine, cytidine, D-asparagine, adenosine, H-Ala-Thr-OH, D-glucuronamide, Ala-asp, Ala-His, Gly-Met, N-acetyl-D-galactosamine, pyrimidine, L-serine, inosine, D-alanine, N-acetyl-D-mannosamine, Gly-Asn, Ala-Glu, D-galactosamine HCl, D-glucosamine HCl, DL-a-amino-n-butyric acid, D-mannosamine HCl, Gly-Gln, Gly-Glu, DL-lactamide, Met-Ala, Methyl(2-phenylethyl)amine hydrochloride, Glycyl-alanine, DL- γ-amino-n-butyric acid, and N-acetyl-D-glucosamine. 65124902US01 Antimicrobial Agents In some embodiments, the composition may include one or more antimicrobial agents to increase shelf life. Some suitable antimicrobial agents that may be used in the present disclosure include traditional antimicrobial agents. As used herein, “traditional antimicrobial agents” means compounds that have been recognized by regulatory bodies as providing an antimicrobial effect, such as those listed in the European Union’s Annex V list of preservatives allowed in cosmetics products. Traditional antimicrobial agents include, but are not limited to: succinic acid and salts thereof, propionic acid and salts thereof; salicylic acid and salts thereof; sorbic acid and salts thereof; benzoic acid and salts and esters thereof; formaldehyde; paraformaldehyde; o-phenylphenol and salts thereof; zinc pyrithione; sulfites; hydrogen sulfites; chlorobutanol; benzoic parabens, such as methylparaben, propylparaben, butylparaben, ethylparaben, isopropylparaben, isobutylparaben, benzylparaben, sodium methylparaben and sodium propylparaben; dehydroacetic acid and salts thereof; formic acid and salts thereof; dibromohexamidine isethionate; thimerosal; phenylmercuric salts; undecylenic acid and salts thereof; hexetidine; 5-bromo-5-nitro-1,3-dioxane; 2-bromo-2-nitropropane-1,3,-diol; dichlorobenzyl triclocarban; p-chloro-m-cresol; triclosan; chloroxylenol; imidazolidinyl urea; polyaminopropyl biguanide; phenoxyethanol, methenamine; quaternium-15; climbazole; DMDM hydantoin; benzyl alcohol; piroctone olamine; bromochlorophene; o-cymen-5-ol; methylchloroisothiazolinone; methylisothiazolinone; chlorophene; chloroacetamide; chlorhexidine; chlorhexidine diacetate; chlorhexidine digluconate; chlorhexidine dihydrochloride; phenoxyisopropanol; alkyl (C12-C22) trimethyl bromide and chlorides; dimethyl oxazolidine; diazolidinyl urea; hexamidine; hexamidine diisethionate; glutaral; 7-ethylbicyclooxazolidine; chlorphenesin; sodium hydroxymethylglycinate; silver chloride; benzethonium chloride; benzalkonium chloride; benzalkonium bromide; benzylhemiformal; iodopropynyl butylcarbamate; ethyl lauroyl arginate HCl; citric acid and silver citrate. Other antimicrobial agents that may be added to the compositions of the present disclosure non-traditional antimicrobial agents that are known to exhibit antimicrobial effects in addition to their primary functions, but that have not historically been recognized as antimicrobial agents by regulatory bodies (such as on the European Union’s Annex V list). Examples of these non-traditional antimicrobial agents include, but are not limited to, hydroxyacetophenone, caprylyl glycol, sodium coco- PG dimonium chloride phosphate, phenylpropanol, lactic acid and salts thereof, caprylhydroxamic acid, acid and salts thereof, sodium lauroyl lactylate, phenethyl alcohol, sorbitan caprylate, glyceryl caprate, glyceryl caprylate, ethylhexylglycerin, p-anisic acid and salts thereof, gluconolactone, decylene glycol, 1,2-hexanediol, glucose oxidase and lactoperoxidase, leuconostoc / radish root ferment filtrate and glyceryl laurate. 65124902US01 The amount of the antimicrobial agents in the compositions is dependent on the relative amounts of other components present within the composition. For example, in some embodiments, an antimicrobial agent can be present in the compositions in an amount between about 0.001% to about 5% (by total weight of the composition), in some embodiments between about 0.01 to about 3% (by total weight of the composition), and in some embodiments, between about 0.05% to about 1.0% (by total weight of the composition). In some embodiments, the antimicrobial agent can be present in the composition in an amount less than 0.2% (by total weight of the composition). However, in some embodiments, the composition can be substantially free of any antimicrobial agents. Thus, in some embodiments, the composition does not include a traditional antimicrobial agent or a non-traditional antimicrobial agent. Other suitable additives that may be included in the compositions of the present disclosure include compatible colorants, deodorants, emulsifiers, anti-foaming agents (when foam is not desired), lubricants, skin conditioning agents, skin protectants and skin benefit agents (e.g., aloe vera and tocopheryl acetate), solvents (e.g., water soluble glycol and glycol ethers, glycerin, water soluble polyethylene glycols, water soluble polyethylene glycol ethers, water soluble polypropylene glycols, water soluble polypropylene glycol ethers, dimethylisosorbide), solubilizing agents, suspending agents, builders, (e.g., alkali and alkaline earth metal salts of carbonate, bicarbonate, phosphate, hydrogen phosphate, dihydrogen phosphate, sulfate hydrogen sulfate), wetting agents, chelators, propellants, dyes and / or pigments, and combinations thereof. Compositions can alternatively or additionally be administered to a user through a delivery mechanism such as, for example, a wipe substrate or by being applied to at least a portion of an absorbent article that can deliver the composition to the user. For example, in one embodiment, the composition can be applied to a top sheet of a feminine care pad. In some embodiments, the composition could be administered to a user through a suppository. Another way the compositions may be configured to be administered to a user can be by having the composition configured in the form of a pill that can be ingested by the user. In certain embodiments, suitable substrates, and applicators for delivery to a user include a web, such as a wet laid tissue web or air laid web, gauze, cotton swab, transdermal patch, container or holder.In other embodiments, the substrate may be a nonwoven material, such as a nonwoven web. Particularly preferred applicators include fibrous webs, including flushable and non-flushable cellulosic webs and nonwoven webs of synthetic fibrous material. Useful webs may be wet laid, air laid, meltblown, or spunbonded. Suitable synthetic fibrous material includes meltblown polyethylene, polypropylene, copolymers of polyethylene and polypropylene, bicomponent fibers including polyethylene or 65124902US01 polypropylene, and the like. Useful nonwoven webs may be meltblown, coform, spunbond, airlaid, hydroentangled nonwovens, spunlace, bonded carded webs. In certain embodiments, particularly those in which the composition is applied to a web, it may be desirable that the formulation provide certain physical attributes, such as having a smooth, lubricious, non-greasy feel; the ability to at least partially transfer from the web to the user; the capability to be retained on the web at about room temperature; or the ability to be compatible with the web manufacturing process. In certain embodiments, it is preferred that at least a portion of the composition is transferred from the tissue to the user for the best therapeutic effect. The composition may be applied to a web during formation of the web or after the web has been formed and dried, often referred to as off-line or post-treatment. Suitable methods of applying the composition to a web include methods known in the art such as gravure printing, flexographic printing, spraying, WEKO™, slot die coating, or electrostatic spraying. One particularly preferred method of off- line application is rotogravure printing. In certain embodiments, the composition may still demonstrate an enhanced therapeutic effect even when applied to the substrate. For instance, in some embodiments, after the composition is applied to the substrate, the ratio of growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1.5% wt / vol to about 8.5% wt / vol of the composition in a 48-hour competitive co- culture assay is greater than about 1, such as greater than about 1.25, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.5. The present invention may be better understood by reference to the following examples. EXAMPLES EXAMPLE ONE: PREPARATION OF THE PREBIOTIC COMPOUNDS AND POSITIVE CONTROL Individual prebiotic compounds were prepared at 0.1%, 0.25%, 0.5%, 1%, 2%, 3%, 4%, 5%, 7.5%, 10%, 15%, or 20% wt / vol in API® 50 CHL media (bioMérieux, Marcy-l'Étoile, France). Dextrose was prepared at 2% to serve as the positive control for growth / fermentation. API® 50 CHL media contains minimal amounts of carbon for growth and bromocresol purple as a pH indicator of fermentation. Prebiotics were sterilized via UV disinfection before dissolving in API® 50 CHL media or by sterilizing the aqueous mixture through a 0.22 μM filter membrane (Corning, Corning, NY), stored at 4°C to 6°C until use. 65124902US01 Table 1. Tested prebiotic compounds. Compound Name CAS Number β-Limit Dextrin N / A1Highly Branched Cyclic Dextrin N / A1Dextrin (Soluble Fiber) 9004-53-9 Dextrin Type III (Commercial Grade) 9004-53-9 Dextrose (D-Glucose)250-99-7 Maltodextrin 9050-36-61Not available.2Dextrose was used as the positive control for growth and fermentation. EXAMPLE TWO: HIGH-THROUGHPUT MONOCULTURE ASSAY 180 μL of the prepared prebiotic solutions and the control from Example 1 were added to a sterile, flat bottom, non-treated 96-well microtiter plate (Corning). From freezer stocks, Lactobacillus strains were subcultured twice into De Man, Rogosa, and Sharpe (MRS) broth (BD Difco, Becton Dickinson, Franklin Lakes, NJ) or tryptic soy broth (TSB) (BD Difco, Becton Dickinson) for Escherichia coli, Staphylococcus and Streptococcus anginosus, and then incubated at 37°C anaerobically overnight until stationary. The second broth subculture of Lactobacillus strains was plated onto MRS agar (Teknova, Hollister, CA); E. coli, S. aureus, and S. anginosus were plated onto tryptic soy agar (TSA) (Remel, Thermo Fisher Scientific, Lenexa, KS) and incubated at 37°C anaerobically overnight until stationary. Individual bacterial suspensions were prepared using a sterile swab to transfer colonies from MRS or into API® Suspension media (bioMérieux) to reach the turbidity of a 0.5 McFarland for E. coli, S. aureus, S. anginosus, and a 1 McFarland for Lactobacillus species. The starting cultures were enumerated via serial dilutions and plating. API® 50 CHL media without a prebiotic (minimal or no growth / fermentation control), with dextrose (positive control), and with prebiotic solutions were inoculated with 20 μL of an individual bacterial suspension. The plate was placed into a spectrophotometer Devices, San Jose, CA), and kinetic absorbance reads were performed at three wavelengths (OD430nm, OD590nm, and OD660nm) every 20 minutes for 24-48 hours. A color change from purple to yellow was caused by a drop in pH measured by the increase in OD430nm and a decrease in OD590nm value, indicative of bacterial fermentation. An increase in OD660nm value indicated an increase in turbidity and bacterial growth. 65124902US01 Table 2. High-throughput monoculture results for prebiotic solutions tested at 2% wt / vol with clinical bacterial strains isolated from the bladder and vagina. Growth and fermentation equal to or greater than the positive control is defined as ++, growth and fermentation less than the positive control is defined as +, and minimal / no growth and fermentation is defined as -. nirtxedotlaM + was as2API® 50 CHL media without a prebiotic was used as the minimal or no growth and fermentation control.3Bacteria demonstrated growth but not fermentation of the prebiotic. EXAMPLE THREE: COMPETITIVE CO-CULTURE ASSAY WITH SOLUTIONS From a freezer stock, Lactobacillus crispatus KC18-1173-1 was subcultured twice into MRS broth (BD Difco, Becton Dickinson), and Escherichia coli KC16-7171-8, Escherichia coli KC17-4298-8, Staphylococcus aureus KC17-4367-2, and Streptococcus anginosus KC18-1131-3B were subcultured twice in TSB (BD Difco, Becton Dickinson). The subcultures were incubated at 37°C anaerobically overnight until stationary. The second broth culture of L. crispatus was plated onto an MRS agar plate (Teknova) or TSA plates (Remel, Thermo Fisher Scientific) for E. coli, S. aureus, and S. anginosus, and incubated at 37°C anaerobically overnight until stationary. Individual bacterial suspensions were prepared using a sterile swab to transfer colonies from MRS or TSA into API® Suspension media (bioMérieux) to reach the turbidity of a 2.0 McFarland standard. The starting cultures were enumerated 65124902US01 via serial dilutions and plating.9.8 mL of the preprepared prebiotic solutions from Example 1, dextrose (positive control) from Example 1, and API® 50 CHL media (minimal or no growth / fermentation control) were added to individual 15 mL conical tubes (Corning).100 μL of the L. crispatus suspension and 100 μL of E. coli, S. aureus, or S. anginosus were added to the tubes. The tubes were vortex-mixed for 5 and the two-organism co-cultures were incubated at 37°C anaerobically for 48 hours. After 48 hours, the tubes were vortex-mixed for 30 seconds, and 100-300 μL aliquots were removed from each tube. The solutions were serially diluted and plated onto MRS and TSA in duplicate to enumerate the surviving bacteria. While some objectionable organisms grew poorly on MRS, differentiation between the two organisms included counting the large colonies as L. crispatus and small colonies as E. coli, S. or S. anginosus (if available). While L. crispatus did not always grow well on TSA plates, differentiation between the two organisms included counting the large and opaque colonies as E. coli, S. aureus, or S. anginosus and small and translucent colonies as L. crispatus (if available). Each compound and concentration were tested with at least two biological replicates, and the results were reported as an average. For each organism, the average recovered log CFU / mL was subtracted from the starting to calculate the average log CFU / mL change (Δ) defined as an increase or decrease. Once the log CFU / mL change was calculated, the average log CFU / mL change (Δ) for the API® CHL media without a prebiotic (minimal or no growth / fermentation control) was subtracted from the average log CFU / mL change in the presence of a prebiotic or dextrose (positive control). Colonies of L. crispatus, E. coli, S. aureus, and S. anginosus were tested against in the co-culture assay test method as described above. The therapeutic effect ratio was calculated by comparing the average log CFU / mL recovered after the competition period of both L. crispatus and E. coli, S. aureus, or S. anginosus, and calculating the ratio of L. crispatus / E. coli, S. aureus, or S. anginosus. A larger number indicates an increase in L. crispatus and / or a decrease in E. coli, S. aureus, or S. anginosus, whereas a smaller number indicates a decrease in L. crispatus and / or an increase in E. coli, aureus, or S. anginosus. The results are demonstrated by Figs.1- 4 and Tables 3-4 below. 65124902US01 Table 3. Overview of 48-hour period on assay results between Lactobacillus and an objectionable strain after exposure to 2% wt / vol prebiotic solution concentrations. Results include the average starting and recovered log CFU / mL, average log CFU / mL change (Δ), and average ratios of Lactobacillus to objectionable strains. Each compound and combination of organisms was tested with at least four biological replicates. PrebioticAverage Log CFU / mL2CompoundCombination1 Bacterial StrainStart Recovered Δ A4 Escherichia coli KC16-7171-8 6.48 5.82 -3.02Lactobacillus crispatus KC18-1173-1 5.57 8.86 2.801.52B5 Escherichia coli KC17-4298-8 6.50 5.54 -3.22Lac β-Limittobacillus crispatus KC18-1173-1 5.53 8.71 3.05DextrinC6 Staphylococcus aureus KC17-4367-2 6.45 4.66 -2.43Lactobacillus crispatus KC18-1173-1 5.50 8.96 2.67 1.92D7 Streptococcus anginosus KC18-1131-3B 6.49 5.21 -1.90Lactobacillus crispatus KC18-1173-1 5.53 8.42 2.19 1.61EEscherichia coli KC16-7171-8 6.51 9.04Lactobacillus crispatus KC18-1173-1 5.53 6.42 0.712%Escherichia coli KC17-4298-8 6.50 8.93 0.17DextrinBLactobacillus crispatus KC18-1173-1 5.53 6.31 0.650.71(SolubleStaphylococcus aureus KC17-4367-2 6.45 7.85 0Fiber)C .76Lactobacillus crispatus KC18-1173-1 5.50 6.74 0.45 0.86DStreptococcus anginosus KC18-1131-3B 6.49 6.38 -0.73Lactobacillus crispatus KC18-1173-1 5.53 6.17 -0.06 0.97EEscherichia coli KC16-7171-8 6.51 9.00Lactobacillus c 0.942%rispatus KC18-1173-1 5.53 8.42BEscherichia coli KC17-4298-8 6.50 8.96Lactobacillus crispatus KC18-1173-1 5.53 0.95Type III8.55(CommercialCStaphylococcus aureus KC17-4367-2 6.45 7.23 0.13Lactobacillus crispatus KC18-1173-1 5. 1.20Grade)50 8.65 2.36DStreptococcus anginosus KC18-1131-3B 6.49 7.10 -Lactobacillus crispatus KC18-1173-1 5.53 8.21 1.99 1.16EEscherichia coli KC16-7171-8 6.51 4.82 -4.00Lact 1.852%obacillus crispatus KC18-1173-1 5.53 8.91 2.76HighlyB Escherichia coli KC17-4298-8 6.50 5.88 -2.88Lactobacillus c1.53Branchedrispatus KC18-1173-1 5.53 8.99 3.34CyclicC Staphylococcus aureus KC17-4367-2 6.45 4.53 -2.57Lactobacill 1.94Dextrinus crispatus KC18-1173-1 5.50 8.78 2.48DStreptococcus anginosus KC18-1131-3B 6.49 5.18 -Lactobacillus crispatus KC18-1173-1 5.53 8.31 EEscherichia coli KC16-7171-8 6.51 5.91 -Lactobacillus crispatus KC18-1173-1 5.53 9.03 2.891.53Escherichia coli KC17-4298-8 6.50 5.30 -3.472%BLactobacillus crispatus KC18-1173-1 5.53 9.02 3.361.70Maltodextrin CStaphylococcus aureus KC17-4367-2 6.45 4.93 -2.17Lactobacillus crispatus KC18-1173-1 5.50 8.83 2.53 1.79D Streptococcus anginosus KC18-1131-3B 6.49 1.93 -5.18Lactobacillus crispatus KC18-1173-1 5.53 8.90 2.684.611The average log CFU / mL change (Δ) for the background growth on API® 50 CHL without an added prebiotic was subtracted from the final log CFU / mL Δ. Each combination has a footnote with the average log CFU / mL values that were subtracted.2Average log CFU / mL values were obtained from MRS plates for L. crispatus KC18-1173-1 and TSA plates for E.coli KC16- 7171-8, E.coli KC17-4298-8, S. aureus KC17-4367-2, and S. anginosus KC18-1131-3B.3Ratio was determined by dividing the average log CFU / mL recovered for L. crispatus KC18-1173-1 by the average log CFU / mL recovered for E.coli KC16-7171-8, E.coli KC17-4298-8, S. aureus KC17-4367-2, or S. anginosus KC18-1131-3B.4Average background log CFU / mL Δ for A was 0.49 for L. crispatus KC18-1173-1 and 2.36 for E. coli KC16-7171-8.5Average background log CFU / mL Δ for B was 0.13 for L. crispatus KC18-1173-1 and 2.27 for E. coli KC17-4298-8.6Average background log CFU / mL Δ for C was 0.79 for L. crispatus KC18-1173-1 and 0.65 for S. aureus KC17-4367-2.7Average background log CFU / mL Δ for D was 0.69 for L. crispatus KC18-1173-1 and 0.62 for S. anginosus KC18-1131-3B.8Average background log CFU / mL Δ for E was 0.61 for L. crispatus KC18-1173-1 and 2.32 for E. coli KC16-7171-8. 65124902US01 Table 4. Overview of 48-hour competitive co-culture assay results between Lactobacillus and an objectionable strain after exposure to different prebiotic solution concentrations (% wt / vol). Results include the average starting and recovered log CFU / mL, average log CFU / mL change (Δ), and average ratios of Lactobacillus to objectionable strains. Each compound and combination of organisms was tested at least two biological replicates. Prebiotic Average Log CFU / mL2CompoundCombination1Bacterial Strain Start Recovered Δ A4 Escherichia coli KC16-7171-8 6.35 8.92 0.05Lactobacillus crispatus KC18-1173-1 5.68 6.49 0.300.73Escherichia coli KC17-4298-8 6.40 8.91 0.00.1%B5 00.57β-LimitLactobacillus crispatus KC18-1173-1 5.59 5.05 -0.40DextrinC6 Staphylococcus aureus KC17-4367-2 6.46 7.25 0.20Lactobacillus crispatus KC18-1173-1 5.69 7.57 1.13 1.04D7 Streptococcus anginosus KC18-1131-3B 6.43 7.10 0.40Lactobacillus crispatus KC18-1173-1 5.69 7.11 0.961.00A Escherichia coli KC16-7171-8 6.35 9.00 0.13Lactobacillus crispatus KC18-1173-1 5.68 7.58 1.380.84Escherichia coli KC17-4298-8 6.40 8.92 0.010.25%BLactobacillus crispatus KC10.60β-Limit8-1173-1 5.59 5.32 -0.13DextrinC Staphylococcus aureus KC17-4367-2 6.46 7.36 0.30Lactobacillus crispatus KC18-1173-1 5.69 7.89 1.451.07DStreptococcus anginosus KC18-1131-3B 6.43 7.08 0.38Lactobacillus crispatus KC18-1173-1 5.69 7.91 1.75 1.12AEscherichia coli KC16-7171-8 6.35 8.59 -0.28Lactobacillus crispatus KC18-1173-1 5.68 7.72 1.530.90Escherichia coli KC17-4298-80.5%B 6.40 8.83 -0.08Lactobacillus cr0.88β-Limitispatus KC18-1173-1 5.59 7.77 2.32DextrinCStaphylococcus aureus KC17-4367-2 6.46 7.36 0.31Lactobacillus crispatus KC18-1173-1 5.69 8.51 2.07 1.16DStreptococcus anginosus KC18-1131-3B 6.43 7.13 0.43Lactobacillus crispatus KC18-1173-1 5.69 8.25 2.09 1.16E8 Escherichia coli KC16-7171-8 6.30 8.44 -0.47Lactobacillus crispatus KC18-1173-1 5.58 8.94 2.681.06 Escherichia coli KC17-4298-8 6.40 8.86 -1%B 0.05Lactobacillus crispatus KC18-1173-1 5.59 8.92 3.47 1.01β-Limit DextrinF9 Staphylococcus aureus KC17-4367-2 6.40 5.23 -1.90Lactobacillus crispatus KC18-1173-1 5.73 9.07 2.64 1.73DStreptococcus anginosus KC18-1131-3B 6.43 6.13 -0.57Lactobacillus crispatus KC18-1173-1 5.69 8.32 2.17 1.36G10 Escherichia coli KC16-7171-8 6.48 5.82 -3.02Lactobacillus crispatus KC18-1173-1 5.57 8.86 2.801.52Escherichia coli KC17-4298-8 6.50 5.54 -3.222%H11Lactobacillus crispatus KC18-1 1.57β-Limit173-1 5.53 8.71 3.05DextrinI12 Staphylococcus aureus KC17-4367-2 6.45 4.66 -2.43Lactobacillus crispatus KC18-1173-1 5.50 8.96 2.671.92J13 Streptococcus anginosus KC18-1131-3B 6.49 5.21 -1.90Lactobacillus crispatus KC18-1173-1 5.53 8.42 2.19 1.62 65124902US01 Prebiotic Average Log CFU / mL2CompoundCombination1Bacterial Strain Ratio3Start Recovered Δ K14 Escherichia coli KC16-7171-8 6.22 5.16 -3.74 Lactobacillus crispatus KC18-1173-1 5.63 9.22 3.061.79Escherichia coli KC17-4298-8 6.33%L156 5.21 -3.73 Lactobacillus crispatus KC18-1173-1 5.62 9.04 3.661.74β-Limit DextrinFStaphylococcus aureus KC17-4367-2 6.40 4.52 -2.61 Lactobacillus crispatus KC18-1173-1 5.73 8.91 2.48 1.97DStreptococcus anginosus KC18-1131-3B 6.43 4.40 -2.30 Lactobacillus crispatus KC18-1173-1 5.69 8.72 2.57 1.98AEscherichia coli KC16-7171-8 6.35 5.39 -3.05 Lactobacillus crispatus KC18-1173-1 5.68 9.21 3.01 1.71Escherichia coli KC17-4298-8 6.40 4.4%B 40 -4.51 Lactobacillus crispatu2.03β-Limits KC18-1173-1 5.59 8.93 3.48DextrinF Staphylococcus aureus KC17-4367-2 6.40 4.41 -2.72 Lactobacillus crispatus KC18-1173-1 5.73 8.89 2.462.02DStreptococcus anginosus KC18-1131-3B 6.43 4.16 -2.55 2.11Lactobacillus crispatus KC18-1173-1 5.69 8.78 2.62 Escherichia coli KC16-7171-8 6.34 4.64 -4.23Lactobacillus crispatus KC18-1173-1 5.74 9.46 3.24 2.04Escherichia coli KC17-4298-8 6.40 4.93 -4.775%B Lactobacillus crispatus KC18-1 1.84β-Limit173-1 5.59 9.09 3.64DextrinF Staphylococcus aureus KC17-4367-2 6.40 5.51 -1.62Lactobacillus crispatus KC18-1173-1 5.73 9.17 2.74 1.66D Streptococcus anginosus KC18-1131-3B 6.43 3.54 -3.16Lactobacillus crispatus KC18-1173-1 5.69 8.98 2.83 2.54Escherichia coli KC16-7171-8 6.37 8.87 0.01 Lactobacillus crispatus KC18-1173-1 5.66 6.96 0.750.780.1%EscheriHighlyB chia coli KC17-4298-8 6.40 8.83 -0.08 Lactobacillus crispatus KC18-10.58Branched173-1 5.59 5.14 -0.31CyclicStaphylococcus aureus KC17-4367-2 6.48 7.46 0.44 1.13Dextrin Lactobacillus crispatus KC18-1173-1 5.64 8.44 2.03 D0.94N 0.89 0.25%Escherichia coli KC17-4298-8 6.40 8hlyB.86 -0.05Hig Lactobacillus cr 0.85Branchedispatus KC18-1173-1 5.59 7.56 2.11CyclicO Staphylococcus aureus KC17-4367-2 6.48 7.04 0.02rinLactobacillus 1.23Dextcrispatus KC18-1173-1 5.64 8.69 2.28D Streptococcus anginosus KC18-1131-3B 6.43 7.24 0.54Lactobacillus crispatus KC18-1173-1 5.69 7.44 1.291.03N Escherichia coli KC16-7171-8 6.37 8.86 0.00Lactobacillus crispatus KC18-1173-1 5.66 8.38 2.170.95 0.5% BEscherichia coli KC17-4298-8 6.40 8.88 -0.03Highly Lactobacillus crispatus KC18-1173-1 5.59 8.01 2 0.90Branched.56CyclicO Staphylococcus aureus KC17-4367-2 6.48 5.30 -1.72Lacto1.66Dextrinbacillus crispatus KC18-1173-1 5.64 8.81 2.39D Streptococcus anginosus KC18-1131-3B 6.43 7.14 0.44Lactobacillus crispatus KC18-1173-1 5.69 8.16 2.011.14 65124902US01 PrebioticCompoundCombination1Average Log CFU / mL2Bacterial Strain Ratio3Start Recovered Δ P19 1.371%Escherichia coli KC17-4298-8 6.40 8.84 -0HighlyB .08Lacto 0.99Branchedbacillus crispatus KC18-1173-1 5.59 8.79 3.34CyclicF Staphylococcus aureus KC17-4367-2 6.40 4.70 -2.43Lactobacillus cris1.88Dextrinpatus KC18-1173-1 5.73 8.84 2.411.281.85 2%Escherichia coli KC17-4298-8 6.50 5.88 -HighlyH 2.88Lactobacillus crispatus K 1.53BranchedC18-1173-1 5.53 8.99 3.34-1.941.601.87 3%Escherichia coli KC17-4298-8 6.27 4.69 -4.16Highly Lactobacillus crispatus KC 1.93Branched18-1173-1 5.55 9.07 4.03CyclicT23 Staphylococcus aureus KC17-4367-2 6.60 4.69 -2.24Lactobacillus crispatus KC18-1173-1 5. 1.91Dextrin67 8.96 2.46D- 1.74U24 Escherichia coli KC16-7171-8 6.30 4.75 -4.11Lactobacillus crispatus KC18-1173-1 5.75 9.05 2.751.914%Escherichia coli KC17-4298-8 6.33 4.09 -3.92Highly Lactobacillus crispatus KC18-1173-1 2.20Branched5.68 8.99 3.48CyclicW26Staphylococcus aureus KC17-4367-2 6.54 4.79 - 1.87Dextrin Lactobacillus crispatus KC18-1173-1 5.77 8.96 2.44 D - 1.90X27 Escherichia coli KC16-7171-8 6.26 4.93 -3.92Lactobacillus crispatus KC18-1173-1 5.68 9.17 2.93 1.865%Escherichia coli KC17-4298-8 6.17 4.47 -Highly 4.36Lacto 2.04Branchedbacillus crispatus KC18-1173-1 5.60 9.13 4.02CyclicZ29 Staphylococcus aureus KC17-4367-2 6.49 4.43 -2.74Lactobacillus cri2.02Dextrinspatus KC18-1173-1 5.81 8.93 2.342.04 65124902US01 Prebiotic CompoundCombination1Average Log CFU / mL2Bacterial Strain Ratio3Start Recovered Δ AA30 Escherichia coli KC16-7171-8 6.30 4.91 -2.90Lactobacillus crispatus KC18-1173-1 5.52 8.82 2.78 1.807.5% 3Escherichia coli KC17-4298-8 6.32 4.85 -2.96HighlyAB1Lactobacillus crispatus KC18- 1.82Branched1173-1 5.52 8.80 2.78CyclicAC32 Staphylococcus aureus KC17-4367-2 6.32 4.91 -2.53Lactobacillus crispatus KC11.78Dextrin8-1173-1 5.52 8.76 2.731.77AA 1.9410% AB Escherichia coli KC17-4298-8 6.32 4.63 -3.18Highly Lactobacillus cri1.93Branchedspatus KC18-1173-1 5.52 8.93 2.90CyclicStaphylococcus aureus KC17-4367-2 6.32 4.74 -2.69 Lactobacillus cris1.86Dextrinpatus KC18-1173-1 5.52 8.84 2.82Streptococcus anginosus KC18-1131-3B 6.32 4.72 -2.67 Lactobacillus crispatus KC18-1173-1 5.52 8.79 2.75 1.86AAEscherichia coli KC16-7171-8 6.30 3.88 -3.93Lactobacillus crispatus KC18-1173-1 5.52 9.14 3.112.3515% hlyABEscherichia coli KC17-4298-8 6.32 3.71 -4.11Hig2.42BranchedLactobacillus crispatus KC18-1173-1 5.52 8.95 2.93CyclicAC Staphylococcus aureus KC17-4367-2 6.32 3.76 -3.682nLactobacillus crispatus KC.37Dextri18-1173-1 5.52 8.93 2.90AD Streptococcus anginosus KC18-1131-3B 6.32 3.59 -3.80Lactobacillus crispatus KC18-1173-1 5.52 8.89 2.852.48AA Escherichia coli KC16-7171-8 6.30 -4.80Lactobacillus crispatus KC18-1173-1 5.523.04 3.1220%Escherichia coli KC17-4298-8 6.32 -4hlyAB .97HigLactobacillus crispatus KC18-1173-1 5.52 3.3.19 Branched02CyclicACStaphylococcus aureus KC17-4367-2 6.32 -5.143.95Dextrin Lactobacillus crispatus KC18-1173-1 5.52 3.05 ADStreptococcus anginosus KC18-1131-3B 6.32 -5.87Lactobacillus crispatus KC18-1173-1 5.52 5.91 2.951The average log CFU / mL change (Δ) for the background growth on API® 50 CHL without an added prebiotic was subtracted from the final log CFU / mL Δ. Each combination has a footnote with the average log CFU / mL values that were subtracted.2Average log CFU / mL values were obtained from MRS plates for L. crispatus KC18-1173-1 and TSA plates for E.coli KC16- 7171-8, E.coli KC17-4298-8, S. aureus KC17-4367-2, and S. anginosus KC18-1131-3B.3Ratio was determined by dividing the average log CFU / mL recovered for L. crispatus KC18-1173-1 by the average log CFU / mL recovered for E.coli KC16-7171-8, E.coli KC17-4298-8, S. aureus KC17-4367-2, or S. anginosus KC18-1131-3B.4Average background log CFU / mL Δ for A was 0.51 for L. crispatus KC18-1173-1 and 2.52 for E. coli KC16-7171-8.5Average background log CFU / mL Δ for B was -0.14 for L. crispatus KC18-1173-1 and 2.51 for E. coli KC17-4298-8.6Average background log CFU / mL Δ for C was 0.75 for L. crispatus KC18-1173-1 and 0.60 for S. aureus KC17-4367-2.7Average background log CFU / mL Δ for D was 0.47 for L. crispatus KC18-1173-1 and 0.27 for S. anginosus KC18-1131-3B.8Average background log CFU / mL Δ for E was 0.68 for L. crispatus KC18-1173-1 and 2.60 for E. coli KC16-7171-8.9Average background log CFU / mL Δ for F was 0.70 for L. crispatus KC18-1173-1 and 0.73 for S. aureus KC17-4367-2.10Average background log CFU / mL Δ for G was 0.49 for L. crispatus KC18-1173-1 and 2.36 for E. coli KC16-7171-8.11Average background log CFU / mL Δ for H was 0.13 for L. crispatus KC18-1173-1 and 2.27 for E. coli KC17-4298-8.12Average background log CFU / mL Δ for I was 0.79 for L. crispatus KC18-1173-1 and 0.65 for S. aureus KC17-4367-2.13Average background log CFU / mL Δ for J was 0.66 for L. crispatus KC18-1173-1 and 0.62 for S. anginosus KC18-1131-3B.14Average background log CFU / mL Δ for K was 0.53 for L. crispatus KC18-1173-1 and 2.67 for E. coli KC16-7171-8.15Average background log CFU / mL Δ for L was -0.23 for L. crispatus KC18-1173-1 and 2.58 for E. coli KC17-4298-8.16Average background log CFU / mL Δ for M was 0.48 for L. crispatus KC18-1173-1 and 2.53 for E. coli KC16-7171-8.17Average background log CFU / mL Δ for N was 0.55 for L. crispatus KC18-1173-1 and 2.49 for E. coli KC16-7171-8.18Average background log CFU / mL Δ for O was 0.54 for L. crispatus KC18-1173-1 and 0.77 for S. aureus KC17-4367-2. 65124902US0119Average background log CFU / mL Δ for P was 0.66 for L. crispatus KC18-1173-1 and 2.58 for E. coli KC16-7171-8.20Average background log CFU / mL Δ for Q was 0.61 for L. crispatus KC18-1173-1 and 2.32 for E. coli KC16-7171-8.21Average background log CFU / mL Δ for R was 0.51 for L. crispatus KC18-1173-1 and 2.66 for E. coli KC16-7171-8.22Average background log CFU / mL Δ for S was -0.51 for L. crispatus KC18-1173-1 and 2.58 for E. coli KC17-4298-8.23Average background log CFU / mL Δ for T was 0.33 for L. crispatus KC18-1173-1 and 0.82 for S. aureus KC17-4367-2.24Average background log CFU / mL Δ for U was 0.54 for L. crispatus KC18-1173-1 and 2.56 for E. coli KC16-7171-8.25Average background log CFU / mL Δ for V was -0.16 for L. crispatus KC18-1173-1 and 2.53 for E. coli KC17-4298-8.26Average background log CFU / mL Δ for W was 0.74 for L. crispatus KC18-1173-1 and 0.55 for S. aureus KC17-4367-2.27Average background log CFU / mL Δ for X was 0.56 for L. crispatus KC18-1173-1 and 2.59 for E. coli KC16-7171-8.28Average background log CFU / mL Δ for Y was -0.49 for L. crispatus KC18-1173-1 and 2.66 for E. coli KC17-4298-8.29Average background log CFU / mL Δ for Z was 0.77 for L. crispatus KC18-1173-1 and 0.67 for S. aureus KC17-4367-2.30Average background log CFU / mL Δ for AA was 0.52 for L. crispatus KC18-1173-1 and 1.51 for E. coli KC16-7171-8.31Average background log CFU / mL Δ for AB was 0.51 for L. crispatus KC18-1173-1 and 1.49 for E. coli KC17-4298-8.32Average background log CFU / mL Δ for AC was 0.50 for L. crispatus KC18-1173-1 and 1.12 for S. aureus KC17-4367-2.33Average background log CFU / mL Δ for AD was 0.52 for L. crispatus KC18-1173-1 and 1.07 for S. anginosus KC18-1131- 3B. As demonstrated by Table 3, β-limit dextrin and highly branched cyclic dextrin at 2% wt / vol increased recovered L. crispatus KC18-1173-1 by >2.0 log CFU / mL compared to the starting inoculum while decreasing objectionable bacteria by ≥1.9 log CFU / mL. As demonstrated by Table 4, β-limit dextrin and highly branched cyclic dextrin showed a therapeutic effect at concentrations as low as 0.1% wt / vol. Further, Table 4 demonstrates stronger therapeutic effects when the compound is tested at higher concentrations. For instance, β-limit dextrin demonstrated stronger therapeutic effects when the concentration was between 1% wt / vol to 5% wt / vol, while highly branched cyclic dextrin demonstrated stronger therapeutic effects when the concentration was between 1% wt / vol to 20% wt / vol. EXAMPLE FOUR: COMPETITIVE CO-CULTURE ASSAY WITH TREATED NONWOVENS From a freezer stock, Lactobacillus crispatus KC18-1173-1 and Lactobacillus crispatus KC18-1174- 1 were subcultured twice into MRS broth (BD Difco, Becton Dickinson), and Escherichia coli KC17-4296- 4 and Staphylococcus aureus KC17-4367-2 were subcultured twice in TSB (BD Difco, Becton Dickinson). The subcultures were incubated at 37°C anaerobically overnight until stationary. The second broth culture of L. crispatus was plated onto an MRS agar plate (Teknova) or TSA plates (Remel, Thermo Fisher Scientific) for E. coli and S. aureus, and incubated at 37°C anaerobically overnight until stationary. Individual bacterial suspensions were prepared using a sterile swab to transfer colonies from MRS or TSA into API® Suspension media (bioMérieux) to reach the turbidity of a 2.0 McFarland standard. The starting cultures were enumerated via serial dilutions and plating. Treated nonwoven materials were cut to desired size (70-150 cm2) and placed in 15 mL conical tubes (Corning). Depending on the size of the nonwoven materials, API® 50 CHL media (2.5-5 mL) and bacterial suspensions (50-100 μL) were added to saturate the nonwoven materials. 9.8 mL of the preprepared prebiotic solutions from Example 1, dextrose (positive control) from Example 1, and API® 50 CHL media (minimal or no growth / fermentation control) were added to individual 15 mL conical tubes (Corning).100 μL of the L. crispatus suspension and 100 μL of E. coli or S. aureus were added to the tubes. The tubes were vortex-mixed for 5 seconds, 65124902US01 and the two-organism co-cultures were incubated at 37°C anaerobically for 48 hours. After 48 hours, the tubes with solutions were vortex-mixed for 30 seconds, and 100-300 μL aliquots were removed from each tube. The tubes with nonwoven materials were sonicated for 1 minute on, 1 minute off, for a total of 5 minutes of sonication, followed by vortex-mixing for 30 seconds.100-300 μL aliquots were removed from each tube, and the solutions were serially diluted and plated onto MRS and TSA in duplicate to enumerate the surviving bacteria. While some objectionable organisms grew poorly on MRS, differentiation between the two organisms included counting the large colonies as L. crispatus and small colonies as E. coli or S. aureus (if available). While L. crispatus did not always grow well on TSA plates, differentiation between the two organisms included counting the large and opaque colonies as E. coli or S. aureus and small and translucent colonies as L. crispatus (if available). Each compound and concentration were tested with at least three biological replicates, and the results were reported as an average. For each organism, the average recovered log CFU / mL was subtracted from the starting inoculum to calculate the average log CFU / mL change (Δ) defined as an increase or decrease. Once the log CFU / mL change was calculated, the average log CFU / mL change (Δ) for the API® CHL media without a prebiotic (minimal or no growth / fermentation control) was subtracted from the average log CFU / mL change in the presence of a prebiotic or dextrose (positive control). Colonies of L. crispatus, E. coli and S. aureus were tested against in the competitive co-culture assay test method as described above. The therapeutic effect ratio was calculated by comparing the average log CFU / mL recovered after the competition period of both L. crispatus and E. coli or S. aureus and calculating the ratio of L. crispatus / E. coli or S. aureus. A larger number indicates an increase in L. crispatus and / or a decrease in E. coli or S. aureus, whereas a smaller number indicates a decrease in L. crispatus and / or an increase in E. coli or S. aureus. The results are demonstrated by Table 5 below.

[0002] 65124902US01 Table 5. Overview of 48-hour competitive co-culture assay results between Lactobacillus and an objectionable strain after exposure to nonwoven materials treated with different concentrations (% wt / wt) of highly branched cyclic dextrin. Results include the average starting and recovered log CFU / mL, average log CFU / mL change (Δ), and average ratios of Lactobacillus to objectionable strains. Each and combination of organisms was tested with at least three biological replicates. Treated Average Log CFU / mL2Material Combination1Bacterial Strain Concentrations Start Recovered Δ A4 Escherichia coli KC17-4296-4 6.45 8.48Lactobacillus crispatus KC18-1173-1 5.80 6.42 0.760% (Untreated)B5 Staphylococcus aureus KC17-4367-2 6.59 7.87Lactobacillus crispatus KC18-1173-1 5.77 6.50 0.83C6 Staphylococcus aureus KC17-4367-2 6.63 7.71 -Lactobacillus crispatus KC18-1174-1 5.70 6.52 0.23 0.85D7 Escherichia coli KC17-4296-4 6.52 7.79 0.09Lactobacillus crispatus KC18-1173-1 5.85 6.81 0.82 0.87 0.5% Highly Branched CyclicE8 Staphylococcus aureus KC17-4367-2 6.64 7.68 -Lactobacillus crispatus KC18-1173-1 5.85 0.90Dextrin6.94F9 Staphylococcus aureus KC17-4367-2 6.63 7.75Lactobacillus crispatus KC18-1174-1 5.80 6.98 0.90D Escherichia coli KC17-4296-4 6.52 7.21 -0.49Lactobacillus crispatus KC18-1173-1 5.85 7.39 1.40 1.031.5% Highly Branched CyclicG10 Staphylococcus aureus KC17-4367-2 6.64 6.74 -xtrinLacto 1.10Debacillus crispatus KC18-1173-1 5.79 7.45FStaphylococcus aureus KC17-4367-2 6.63 6.75 -Lactobacillus crispatus KC18-1174-1 5.80 7.49 1.05 1.11D Escherichia coli KC17-4296-4 6.52 6.14 -1.56Lactobacillus crispatus KC18-1173-1 5.85 8.21 2.22 1.342.5% Highly Branched CyclicG Staphylococcus aureus KC17-4367-2 6.64 5.68 -trinLactobacil 1.44Dexlus crispatus KC18-1173-1 5.79 8.16 1.92H11 Staphylococcus aureus KC17-4367-2 6.63 6.07 -1.67Lactobacillus crispatus KC18-1174-1 5.79 8.02 1.60 1.32hly12 Escherichia coli KC17-4296-4 6.52 7.18 -0.653% Hig I 1.08 Branched CyclicLactobacillus crispatus KC18-1173-1 5.80 7.74 1.06DextrinJ13 Staphylococcus aureus KC17-4367-2 6.60 7.19 -Lactobacillus crispatus KC18-1173-1 5.80 7.84 1.16 1.09Escherichia coli KC17-4296-4 6.52 5.38 -2.3.5% HighlyD32Lactobacillu 1.33Branched Cyclics crispatus KC18-1173-1 5.85 7.16 1.17DextrinGStaphylococcus aureus KC17-4367-2 6.64 5.45 -2.24Lactobacillus crispatus KC18-1173-1 5.79 7.88 1.63 1.45K14 Escherichia coli KC17-4296-4 6.40 6.47 -2.07Lactobacillus crispatus KC18-1173-1 5.80 8.42 2.311.305% Highly Branched CyclicL15 Staphylococcus aureus KC17-4367-2 6.56 4.34 -3.50DextrinLactobacillus crispatus KC18-1173-1 5.76 8.33 2.04M16 Staphylococcus aureus KC17-4367-2 6.63 4.60 -3.17Lactobacillus crispatus KC18-1174-1 5.65 8.13 1.92 1.77 65124902US01 Treated Average Log CFU / mL27% 1The average log CFU / mL change (Δ) for the background growth on API® 50 CHL without an added prebiotic was subtracted from the final log CFU / mL Δ. Each combination has a footnote with the average log CFU / mL values that were subtracted.2Average log CFU / mL values were obtained from MRS plates for L. crispatus KC18-1173-1 and L. crispatus KC18-1174-1 and TSA plates for E.coli KC17-4296-4 and S. aureus KC17-4367-2. was determined by dividing the average log CFU / mL recovered for L. crispatus KC18-1173-1 or L. crispatus KC18- 1174-1 by the average log CFU / mL recovered for E.coli KC17-4296-4 or S. aureus KC17-4367-2.4Average background log CFU / mL Δ for A was 0.32 for L. crispatus KC18-1173-1 and 1.82 for E. coli KC17-4296-4.5Average background log CFU / mL Δ for B was 0.51 for L. crispatus KC18-1173-1 and 1.15 for S. aureus KC17-4367-2. background log CFU / mL Δ for C was 0.60 for L. crispatus KC18-1174-1 and 1.13 for S. aureus KC17-4367-2. background log CFU / mL Δ for D was 0.14 for L. crispatus KC18-1173-1 and 1.17 for E. coli KC17-4296-4.8Average background log CFU / mL Δ for E was 0.50 for L. crispatus KC18-1173-1 and 1.08 for S. aureus KC17-4367-2.9Average background log CFU / mL Δ for F was 0.65 for L. crispatus KC18-1174-1 and 1.12 for S. aureus KC17-4367-2.10Average background log CFU / mL Δ for G was 0.46 for L. crispatus KC18-1173-1 and 1.05 for S. aureus KC17-4367-2. background log CFU / mL Δ for H was 0.62 for L. crispatus KC18-1174-1 and 1.10 for S. aureus KC17-4367-2. background log CFU / mL Δ for I was 0.88 for L. crispatus KC18-1173-1 and 1.31 for E. coli KC17-4296-4.13Average background log CFU / mL Δ for J was 0.88 for L. crispatus KC18-1173-1 and 1.00 for S. aureus KC17-4367-2.14Average background log CFU / mL Δ for K was 0.31 for L. crispatus KC18-1173-1 and 2.14 for E. coli KC17-4296-4.15Average background log CFU / mL Δ for L was 0.53 for L. crispatus KC18-1173-1 and 1.28 for S. aureus KC17-4367-2. background log CFU / mL Δ for M was 0.56 for L. crispatus KC18-1174-1 and 1.13 for S. aureus KC17-4367-2. background log CFU / mL Δ for N was 0.53 for L. crispatus KC18-1173-1 and 1.21 for E. coli KC17-4296-4.18Average background log CFU / mL Δ for O was 0.54 for L. crispatus KC18-1173-1 and 0.90 for S. aureus KC17-4367-2. As demonstrated by Table 5, highly branched cyclic dextrin showed a therapeutic effect at concentrations as low as 0.5% wt / vol. EXAMPLE FIVE: SKIN IRRITATION ASSAYS Reconstructed human epidermis model (EpiDerm™ EPI-200, MatTek Corporation, Ashland, MA) was used for the testing highly branched cyclic dextrin solutions. Tissues were unpacked upon arrival and placed in the 6-well plates (Corning) with 0.9 mL of the pre-warmed assay medium per well. After equilibration of tissues in the incubator at 37°C and 5% CO2, the assay medium was replaced prior to the treatment. Tissues (four replicates / solution) were treated with 100 μL of each solution. Tested solutions included 5% wt / vol highly branched cyclic dextrin, 10% wt / vol highly branched cyclic dextrin, 15% wt / vol highly branched cyclic dextrin, and 20% wt / vol highly branched cyclic dextrin. Milli-Q water was tested as the negative control and 1% vol / vol Triton X-100 (Sigma-Aldrich) was tested as the positive The treated tissues were incubated for 24 hours at 37°C, 5% CO2. After 24 hours, the media was collected and stored at 4°C to 6°C for inflammatory marker (IL-1α and IL-8) analysis using the automated ELISA system (Ella™, Bio-Techne Corporation, Minneapolis, MN). In addition, the tissues were assessed for viability by the MTT assay, conducted according to the instruction provided by the supplier of the MTT 65124902US01 kit (MTT-100, MatTek Corporation). Tissues were rinsed three times with DPBS (Thermo Fisher Scientific) and transferred to a new 24-well plate with the MTT working solution. The plate was incubated at 37°C, 5% CO2for three hours. Each insert was gently dabbed dry and transferred to the MTT extraction plate. The plate was covered with an aluminum foil, sealed with Parafilm (Amcor, Zürich, Switzerland), placed inside a Ziploc bag, and stored in the dark overnight. After the extraction period, the liquid within each insert was decanted back into the well from which it was taken, and the inserts were discarded. The solutions were mixed well, and 200 μL of each sample was transferred to a 96-well plate. The solutions were measured at OD570nm. An extractant blank background was included. The background reading was subtracted from all samples at OD650nm to improve the quality of the data; in addition, wavelengths between OD540-570nm could have been used equally as well. Percent (%) cell viability was calculated as 100 x [OD(sample) / OD(negative control)]. The results are demonstrated in Figs.5-6. As demonstrated by Fig.5, utilizing highly branched cyclic dextrin (“HBCD”), even at high amounts, such as 20% wt / vol, demonstrated little to no impact on cell viability after 24 hours of exposure. As demonstrated by Fig.6, utilizing highly branched cyclic dextrin (“HBCD”), even at high amounts, such as 20% wt / vol, demonstrated little to no increase in inflammatory cytokines. For instance, in certain instances, the use of highly branched cyclic dextrin actually reduced the amount of inflammatory cytokines compared to the negative control. Thus, Figs.5-6 demonstrate that the use of at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, such as a highly branched cyclic dextrin, as a therapeutic agent does not exhibit any adverse skin effects. Embodiments In view of the foregoing description and examples, the present disclosure provides the following embodiments. Embodiment 1: A method for modulating a microbiome of a urogenital area or a skin area of a user, the method comprising: applying a composition to a urogenital area or a skin area of a user, the composition comprising a carrier and a therapeutic agent, the therapeutic agent comprising at least one prebiotic compound, the at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a molecular weight of greater than about 25,000 kDa. Embodiment 2: The method of embodiment 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a cyclic moiety. 65124902US01 Embodiment 3: The method of embodiment 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof. Embodiment 4: The method as in any preceding embodiment, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a highly branched cyclic dextrin. Embodiment 5: The method as in any preceding embodiment, wherein the at least one high molecular dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin. Embodiment 6: The method as in any preceding embodiment, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a purity level of about 80% or greater. Embodiment 7: The method as in any preceding embodiment, wherein the urogenital area of the user comprises the vaginal canal, urethra, or periurethral area. Embodiment 8: The method as in any preceding embodiment, wherein the composition has a pH from about 3 to about 5. Embodiment 9: The method as in any preceding embodiment, wherein the composition further comprises at least one of an additional prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and an antimicrobial agent. Embodiment 10: The method as in any preceding embodiment, wherein the carrier is an aqueous solution. Embodiment 11: The method as in any preceding embodiment, wherein the composition is in the form of a liquid, a gel, a cream, a spray, or a suppository. Embodiment 12: The method as in any preceding embodiment, wherein the composition is free from an alcohol. Embodiment 13: The method as in any preceding embodiment, wherein the therapeutic agent comprises about 0.1% wt / vol to about 20% wt / vol of the composition. Embodiment 14: The method as in any preceding embodiment, wherein the carrier comprises greater than about 90% wt / vol of the composition. 65124902US01 Embodiment 15: The method as in any preceding embodiment, further comprising promoting a healthy microflora balance of the urogenital area or the skin area of the user, wherein promoting the healthy microflora balance of the urogenital area or the skin area of the user comprises promoting a growth of Lactobacillus species relative to a growth of one or more types of bacteria comprising Escherichia coli, aureus, Streptococcus anginosus, or mixtures thereof. Embodiment 16: The method as in any preceding embodiment, wherein a ratio of the growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to 2% wt / vol of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.5 Embodiment 17: The method as in any preceding embodiment, further comprising applying the composition to a substrate, the substrate comprising a wipe or at least a portion of an absorbent article. Embodiment 18: The method as in any preceding embodiment, wherein after application to the substrate, the ratio of growth of Lactobacillus species to the growth of one or more types of bacteria comprising coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1.5% wt / vol to about 8.5% wt / vol of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about 1.25, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.5. Embodiment 19: A composition for modulating a microbiome of a urogenital area or a skin area of a user, composition comprising a single liquid phase, the single liquid phase comprising an aqueous solution and a therapeutic agent, the therapeutic agent comprising at least one prebiotic compound, the at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6- glycosidic bonds, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a molecular weight of greater than about 25,000 kDa. 20: The composition of embodiment 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a cyclic moiety. Embodiment 21: The composition of embodiment 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof. 65124902US01 Embodiment 22: The composition as in any preceding embodiment, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a highly branched cyclic dextrin. Embodiment 23: The composition as in any preceding embodiment, wherein the at least one high weight dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin. Embodiment 24: The composition as in any preceding embodiment, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a purity level of about 80% or greater. Embodiment 25: The composition as in any preceding embodiment, wherein the composition has a pH about 3 to about 5. Embodiment 26: The composition as in any preceding embodiment, wherein the composition further comprises at least one of an additional urogenital prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and an antimicrobial agent. Embodiment 27: The composition as in any preceding embodiment, wherein the composition is in the of a liquid, a gel, a cream, a spray, or a suppository. Embodiment 28: The composition as in any preceding embodiment, further comprising applying the composition to a substrate, the substrate comprising a wipe or at least a portion of an absorbent article Embodiment 29: The composition as in any preceding embodiment, wherein the therapeutic agent comprises from about 0.1% wt / vol to about 20% wt / vol of the composition. 30: The composition as in any preceding embodiment, wherein the composition is not an emulsion. Embodiment 31: The composition as in any preceding embodiment, wherein the composition does not contain any probiotics. Embodiment 32: The composition as in any preceding embodiment, wherein the composition is free from alcohol. All documents cited in the Detailed Description are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this written document conflicts 65124902US01 with any meaning or definition of the term in a document incorporated by references, the meaning or definition assigned to the term in this written document shall govern. While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

65124902US01 WHAT IS CLAIMED IS:

1. A method for modulating a microbiome of a urogenital area or a skin area of a user, the method comprising: applying a composition to a urogenital area or a skin area of a user, the composition comprising: a carrier; and a therapeutic agent, the therapeutic agent comprising at least one prebiotic compound, the at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a molecular weight of greater than about 25,000 kDa.

2. The method of claim 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a cyclic moiety.

3. The method of claim 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof.

4. The method of claim 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a highly branched cyclic dextrin.

5. The method of claim 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin.

6. The method of claim 1, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a purity level of about 80% or greater.

7. The method of claim 1, wherein the urogenital area of the user comprises the vaginal canal, vulva, vagina, urethra, urinary tract, bladder, and / or surrounding areas.

8. The method of claim 1, wherein the composition has a pH from about 3 to about 6.

9. The method of claim 1, wherein the composition further comprises at least one of an additional prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and an antimicrobial agent.

10. The method of claim 1, wherein the carrier is an aqueous solution.

11. The method of claim 1, wherein the composition is in the form of a liquid, a gel, a cream, a spray, or a suppository.

12. The method of claim 1, wherein the composition is free from an alcohol.

13. The method of claim 1, wherein the therapeutic agent comprises about 0.1% wt / vol to about 20% wt / vol of the composition.

14. The method of claim 1, wherein the carrier comprises greater than about 90% wt / vol of the composition.65124902US01 15. The method of claim 1, further comprising promoting a healthy microflora balance of the urogenital area or the skin area of the user, wherein promoting the healthy microflora balance of the urogenital area or the skin area of the user comprises promoting a growth of Lactobacillus species relative to a growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof.

16. The method of claim 15, wherein a ratio of the growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1% wt / vol to about 20% wt / vol of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.

5.

17. The method of claim 1, further comprising applying the composition to a substrate, the substrate comprising a wipe or at least a portion of an absorbent article.

18. The method of claim 17, wherein after application to the substrate, the ratio of growth of Lactobacillus species to the growth of one or more types of bacteria comprising Escherichia coli, Staphylococcus aureus, Streptococcus anginosus, or mixtures thereof after exposure to about 1.5% wt / vol to about 8.5% wt / vol of the composition in a 48-hour competitive co-culture assay is greater than about 1, such as greater than about 1.25, such as greater than about 1.5, such as greater than about 1.75, such as greater than about 2.0, and even greater than about 2.

5.

19. A composition for modulating a microbiome of a urogenital area or a skin area of a user, the composition comprising a single liquid phase, the single liquid phase comprising: an aqueous solution; and a therapeutic agent, the therapeutic agent comprising at least one prebiotic compound, the at least one prebiotic compound including at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a molecular weight of greater than about 25,000 kDa.

20. The composition of claim 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a cyclic moiety.

21. The composition of claim 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds is a highly branched cyclic dextrin, a β-limit dextrin, or a mixture thereof.

22. The composition of claim 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a highly branched cyclic dextrin.65124902US01 23. The composition of claim 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds comprises only a β-limit dextrin.

24. The composition of claim 19, wherein the at least one high molecular weight dextrin with two or more α-1,6-glycosidic bonds has a purity level of about 80% or greater.

25. The composition of claim 19, wherein the composition has a pH from about 3 to about 6.

26. The composition of claim 19, wherein the composition further comprises at least one of an additional urogenital prebiotic, a surfactant, an ester, a humectant, a pH adjuster, a rheology modifier, a gelling agent, a nitrogen source, and an antimicrobial agent.

27. The composition of claim 19, wherein the composition is in the form of a liquid, a gel, a cream, a spray, or a suppository.

28. The composition of claim 27, further comprising applying the composition to a substrate, the substrate comprising a wipe or at least a portion of an absorbent article.

29. The composition of claim 19, wherein the therapeutic agent comprises from about 0.1% wt / vol to about 20% wt / vol of the composition.

30. The composition of claim 19, wherein the composition is not an emulsion.

31. The composition of claim 19, wherein the composition does not contain any probiotics.

32. The composition of claim 19, wherein the composition is free from an alcohol.

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