Compositions for cleansing and suppressing virulence

Abstract

A stable composition for cleansing and suppressing microbial virulence is provided. The composition includes (a) a surfactant comprising (i) a polyethylene glycol compound comprising a fatty acid moiety, and (ii) a fatty acid containing compound, and (b) an aqueous carrier. The surfactant is present in an amount of between 0.01 and 1 wt. %, based on the total weight of the composition; and the composition does not comprise a phosphate containing compound or a metal salt.

Description

[0001]COMPOSITIONS FOR CLEANSING AND SUPPRESSING VIRULENCE BACKGROUND Compositions for virulence suppression are described in, for example, U.S. Patent Application Publication No.2019 / 0247423 to Alverdy et al. DETAILED DESCRIPTION Many known treatments of pathogens result in the destruction of all or nearly all microbes that may be present, even beneficial microbes. Further, because of these treatment methods, there is growing concern about antibiotic resistance that may increase risks to patients, particularly to those undergoing surgical procedures. Commonly, particularly in surgical and ICU settings, such treatments include use of the antiseptics like chlorhexidine gluconate (CHG). In addition to the aforementioned concern with antimicrobial resistance, there is a growing recognition that overuse of CHG in medical facilities can result in issues such as contact dermatitis. Newer approaches have been directed toward suppressing the virulence of the pathogens that causes the infection rather than destroying all microbes. That is, new methods are needed that do not destroy all the beneficial bacteria in the process of preventing the harm done by pathogens. Wound rinses such as saline are used routinely to wash a wound or surgical cavity and can mechanically remove pathogens and debris. In such rinse applications, the wound is cleansed without the use of an antiseptic. Single solutions or treatments that can both cleanse efficiently (i.e., removes microbes and debris) and act on microbes in a manner that suppresses the virulence of harmful pathogens (and, in some cases, not eliminating beneficial microbes) are desirable. Historically, however, single solutions and treatments that have shown good cleansing properties have not been found to suppress virulence effectively (and vice versa). For example, fatty acid glycerides like glyceryl monocaprylate have ineffective cleansing properties, but can permit growth of beneficial microbes and suppress virulence of bacteria effectively. As another example, PEG fatty acid glycerides like stearoyl polyoxyl-32 glycerides have some cleansing properties but do not suppress virulence effectively. In some cases, dilute solutions of betadine, hypochlorous acid have been used to cleanse wounds. While these antiseptics can initially reduce growth, there is usually quick regrowth of organisms. In many cases, it is important to keep the microbial count down for a few days in order to give the immune system a chance to clear the infection. Using higher concentrations of antiseptics could help both with immediate and longer term kill of pathogens, however, they are not used in that way due to potential toxicity to host tissues. Consequently, it would be very beneficial to have stable solutions that kill bacteria quickly, cleanse the wound and keep counts low for longer periods with suppression of virulence of relevant microbes. Generally, in some embodiments, the present disclosure is directed to the surprising discovery of certain solutions that can both cleanse a wound effectively (even at very low concentrations of surfactants) and also suppress virulence of microbes (and, in some cases, without killing all bacteria (including beneficial bacteria). DEFINITIONS: The term “μM” used herein refers to micromolar concentration. The term “mM” used herein refers to millimolar concentration. The term “virulence” refers to a pathogen’s ability to infect or damage a host such as a mammal. The term “virulence suppression” and “suppression of microbial virulence” or similar expressions refer to suppressing or inhibiting the synthesis and / or expression of one or more virulence factors. The term “virulence factor” refers to molecules produced by microbes that enable them to infect a host such as a mammal. The virulence factors of bacteria can be small molecules, proteins, or biofilms (e.g., a slimy buildup of bacteria and polysaccharides on a surface). The virulence factors are typically secreted by a microbe to promote colonization and / or adhesion to a host (e.g., resulting in biofilm formation), to evade the immune response of the host, or to obtain nutrients from the host. As used herein, “surfactant” refers to synthetic and naturally occurring amphiphilic molecules that have hydrophobic portion(s) and hydrophilic portion(s). Due to their amphiphilic (amphipathic) nature, surfactants typically can reduce the surface tension between two immiscible liquids, for example, the oil and water phases in an emulsion, stabilizing the emulsion. Surfactants can be characterized based on their relative hydrophobicity and / or hydrophilicity. For example, relatively lipophilic surfactants are more soluble in fats, oils and waxes, and typically have HLB (hydrophile-lipophile balance) values less than or about 10, while relatively hydrophilic surfactants are more soluble in aqueous compositions, for example, water, and typically have HLB values greater than or about 10. Relatively amphiphilic surfactants are soluble in oil- and water-based liquids and typically have HLB values close to 10. The terms “comprise”, “contain”, “include”, and variations thereof do not have a limiting meaning where these terms appear in the description and claims. Such terms will be understood to imply the inclusion of a stated step or element or group of steps or elements but not the exclusion of any other step or element or group of steps or elements. By “consisting of” is meant including, and limited to, whatever follows the phrase “consisting of.” Thus, the phrase “consisting of” indicates that the listed elements are required or mandatory, and that no other elements may be present. By “consisting essentially of” is meant including any elements listed after the phrase and is limited to other elements that do not interfere with or contribute to the activity or action specified in the disclosure for the listed elements. Thus, the phrase “consisting essentially of” indicates that the listed elements are required or mandatory, but that other elements are optional and may or may not be present depending upon whether they materially affect the activity or action of the listed elements. Any one of the elements or combinations of elements that are recited in this specification in open-ended language (e.g., comprise, include, contain, and derivatives thereof), are considered to additionally be recited in closed-ended language (e.g., consist and derivatives thereof) and in partially closed-ended language (e.g., consist essentially, and derivatives thereof). In this application, terms such as “a”, “an”, and “the” are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration. The terms “a,” “an,” and “the” are used interchangeably with the term “at least one.” The phrases “at least one of” and “comprises at least one of” followed by a list refers to any one of the items in the list and any combination of two or more items in the list. As used herein, the term “or” is generally employed in its usual sense including “and / or” unless the content clearly dictates otherwise. The term “and / or” means one or both. For example, the expression A and / or B means A alone, B alone, or both A and B. Also, the recitations of numerical ranges by endpoints include all numbers subsumed within that range as well as the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.) and any sub-ranges (e.g., 1 to 5 includes 1 to 4, 1 to 3, 2 to 4, etc.). In some embodiments, the present disclosure is directed to compositions for (i) cleansing wounds or surgical sites; and (ii) suppressing microbial virulence within or near such wound or surgical site (without destroying all microbes that may be present). Further, the compositions may be stable even at low pH values, which may facilitate achievement of adequate virulence suppression. In some embodiments, microbial virulence may be suppressed by reducing or inhibiting the formation and / or expression of one or more virulence factors, which are the harmful products that can lead to microbial infections. That is, the virulence suppression compositions can prevent, mitigate, or treat microbial infections. The compositions typically do not prevent continued colonization of microbes such as those that are helpful to the mammal. In some embodiments, the cleansing and suppressing compositions may include (a) a surfactant comprising (i) a polyethylene glycol compound comprising a fatty acid moiety, (ii) a fatty acid containing compound; and (b) an aqueous carrier. Surprisingly, it was discovered that at even very low levels of the above-described surfactants, the compositions of the present disclosure may suppress certain virulence factors that lead to microbial infections. It was also observed that at certain higher concentrations, immediate kill and cleansing along with persistent kill and virulence suppression was possible with stable solutions. In some embodiments, the surfactants of the cleansing and microbial virulence suppressing compositions of the present disclosure may include polyethylene glycol (PEG) compounds that contain fatty acids esters / ethers / amides / monoalkyl glycols or fatty acid esters / ethers / monoalkyl glycols or combinations thereof that are physiologically well tolerated after administration to skin / mucosa / wound / surgical cavity / peritoneal cavity or gut. These components may be selected to be therapeutically acceptable, which means that they are not toxic to the mammal being treated. PEG compounds, also referred to herein as PEGs, together with their derivatives, do not have definite chemical entities, but are compound mixtures having different chain lengths. PEG includes two terminal primary hydroxyl groups that can be used to create mono-, di- and poly-esters, amines, ethers and acetals. PEGs can also create additional compounds and complexes through a reaction in their ether bridges. In the present application, the term PEG compound refers to PEGs and PEG derivatives such as, for example, PEG alkyl ethers (e.g., laureths, ceteths, ceteareths, oleths, and PEG ethers of glyceryl cocoates), PEG alkyl esters (e.g., PEG laurates, dilaurates, stearates, and distearates), PEG castor oils, PEG alkyl amides (e.g., PEG cocamines), PEG propylene glycols, PEG 1,2 diols, and other derivates (e.g., PEG soy sterols and PEG beeswax). Since many PEG types are hydrophilic, they are effective penetration enhancers for use in dermatological preparations. The PEG compounds may be used alone or in combination, or may be used with optional compounds such as any of alkyl esters, alkyl ethers, and alkyl amides, and mixtures and combinations thereof. Any of the alkyl esters, alkyl ethers and alkyl amides can have an alkyl group independently selected to have 8 to 22 carbon atoms. In some embodiments, the alkyl group can include a 1,2 dihydroxy group. In some embodiments, the PEG compounds of the present disclosure may have surfactant properties, and the HLB value (Hydrophile-Lipophile Balance) is used in the present application as an empirical expression for the relationship of the hydrophilic and hydrophobic groups of the PEG compound (or any other surfactant in the composition), and in most cases the higher the HLB value, the more water- soluble the surfactant. In some embodiments of the present disclosure, HLB values are calculated using the method of Griffin (Griffin W C; J. Soc. of Cosmetic Chemists, pp.249-256 (1954)). Thus, as used herein, the "HLB Method" involves a calculation based on the following: HLB = (E + P) / 5, where E is the weight percent of oxyethylene content and P is the weight percent of alcohol content (glycerol, sorbitol, etc.). For the compounds herein, glycerol segments with two hydroxyl groups, glycerol segments with one hydroxyl group, and hydroxyl-containing segments of any additional polyhydric molecules were included in the definition of P. Other methods of calculating the HLB value are available and may be required when determining the HLB value for compounds lacking both E and P groups, as defined above. While the calculated value of HLB may vary depending on the method used, the trends and relative hydrophobicity of materials are expected to be similar. In various embodiments, the PEG compounds of the present may have an HLB value of greater than 8 and less than 18, or greater than 8 and less than 14, or greater than 10 and less than 14. In various embodiments, the PEG compound may include PEG alkyl esters, PEG alkyl ethers, PEG alkyl amides, PEG 1,2 diols, and mixtures and combinations thereof, wherein where the alkyl group on any of the PEG compounds can be independently selected to have 8 to 22 carbon atoms. In some embodiments, the alkyl groups on any of the PEG compounds can include a 1,2 dihydroxy group. In some embodiments, the PEG compound may include a PEG alkyl ester with an alkyl group having 8 to 22 carbon atoms. The PEG alkyl esters, which can also be referred to in the art as PEG fatty acid esters, are the reaction products of a PEG compound (hereafter referred to as a PEG) and a fatty acid. The PEG in the PEG alkyl ester forms a hydrophilic part of the molecule and the C8-C22 alkyl ester component of the PEG alkyl ester forms a lipophilic part of the molecule. By varying the molecular weight of the PEG and the alkyl ester components of the PEG alkyl ester, surfactants covering a wide range of HLB values can be produced. In various embodiments, the PEG alkyl ester is a monoester, a diester or a triester, or a mixture or combination thereof. In some embodiments, the PEG alkyl ester is substantially free of triesters, and in some embodiments the PEG alkyl ester is substantially free of both triesters and diesters, and as such consists substantially of monoesters. In various embodiments, the PEG compound may include a PEG alkyl ester that is a reaction product of a fatty acid component chosen from C8 to C22 fatty acids (fatty acids with 8 to 22 carbon atoms), or C8 to C18 fatty acids, or C8 to C12 fatty acids; and a PEG component with 6 to 60 ethylene oxide units, or 6 to 40 ethylene oxide units, or 6 to 32 ethylene oxide units, or 6 to 10 ethylene oxide units. In some embodiments, the PEG alkyl ester may be a reaction product of an ethoxylated glyceride and a fatty acid. In some embodiments, the fatty acid may be a C8 to C22 fatty acid, and a PEG with 6 to 60 ethylene oxide units. In another embodiment, the PEG alkyl ester is a reaction product of a C8 to C18 fatty acid, and a PEG with 6 to 32 ethylene oxide units. In various example embodiments, the PEG alkyl ester may be chosen from PEG 12 glyceryl laurate, PEG 20 glyceryl laurate, PEG 30 glyceryl laurate, PEG 20 glyceryl stearate, PEG glyceryl caprate, and mixtures and combinations thereof. In any of the embodiments above, the PEG alkyl ester can include a mixture of mono, di, and tri esters. In some embodiments, the PEG alkyl ester includes a mixture of monoesters and diesters, and is substantially free of tri esters, or free of tri esters. In some embodiments, the PEG alkyl ester includes monoesters and is substantially free of diesters and triesters, or free of diesters and triesters. In some example embodiments, the PEG alkyl ester is a reaction product of a PEG and a C8 to C22 fatty acid triester, a reaction product of a PEG and a C8 to C22 fatty acid monoester or diester, or a reaction product of a PEG, a C8 to C22 fatty acid monoester or diester, and a fatty acid mono, di and triester. Suitable commercially available PEG glyceryl alkyl esters include, but are not limited to, those available under the trade designation LABRAFIL from Gattefossé, Lyon, FR, (HLB = 9), LABRASOL from Gattefossé (HLB = 12), and TEFOSE from Gattefossé (HLB = 9-10) and peg glyceryl laurate from Global 7 Suitable commercially available peg fatty acid esters include peg 12 laurate and MYRJ from Gattefosse. In various embodiments, PEG compounds may be present in the virulence suppression compositions in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, or between 0.01 wt% and 1 wt%, or between 0.01 wt% and 0.5 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the cleansing and suppressing composition. In some, embodiments, PEG compounds may be present in the composition in an amount such that the presence of the PEG compounds does not appreciably contribute to an antimicrobial characteristic of the compositions (i.e., the PEG compounds are provided at low enough concentrations such that, in the absence of other antimicrobial components in the compositions, the compositions may allow for microbial growth). In some embodiments, the surfactants of the cleansing and virulence suppressing compositions of the present disclosure may include one or more fatty acid containing compounds (as used herein, unless expressly associated with the term “PEG”, the term “fatty acid containing compounds” does not include PEG compounds containing fatty acid moieties). In some embodiments, suitable fatty acid containing compounds can include esters, ethers, amides, or monoalkyl glycols with the number of carbons in the alkyl group from 8 to 22. In some embodiments, suitable fatty acid esters may be monoesters, diesters, triesters, or a mixture or combination thereof. In some embodiments, the fatty acid ester may be chosen from monoester and diesters, and mixtures and combinations thereof. In some embodiments, the fatty acid ester is a monoester. In some embodiments, suitable fatty acid esters may include those available under the trade designation CAPMUL from Abitec, Columbus, OH (HLB = 6), geleol, Precirol ATO5, Maisine cc, Compritol 888 ATO, Sedefos 75 from Gattefosse. In some embodiments, suitable fatty acid containing compounds include monoalkyl glycol (1,2 diols) and monoalkyl glycerol, or monoacyl glycerol where the number of carbons in the alkyl group can go from 8 to 22. In some embodiments, the fatty acid containing compounds of the present may have an HLB value of greater than 8 and less than 18, or greater than 8 and less than 14, or greater than 10 and less than 14. In various embodiments, fatty acid containing compounds may be present in the surfactant in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, or between 0.01 wt% and 1 wt%, , or between 0.01 wt% and 0.5 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the composition (including the aqueous carrier). In some embodiments, fatty acid containing compounds may be present in the composition in an amount such that the composition does not exhibit antimicrobial properties. It is to be appreciated that in some embodiments, the presence of fatty acid containing compounds at lower than 2 wt% may result in instability of the cleansing and virulence suppressing compositions at pH values lower than about 6 or 5.5. Consequently, at such low concentrations and low pH, as provided for in the present disclosure additional components are added to the compositions to ensure stability. In some embodiments, the cleaning and suppressing compositions may include (a) a surfactant comprising (i) a polyethylene glycol compound comprising a fatty acid ester moiety, and (ii) a polyethylene glycol compound comprising a fatty acid glyceride; and (b) an aqueous carrier. Surprisingly, it was discovered that the combination of (i) and (ii) resulted in improved cleansing while still suppressing virulence. In some embodiments, the surfactants of the cleansing and microbial virulence suppressing compositions of the present disclosure may include PEG compounds that contain fatty acids esters, or PEG fatty acid esters. As discussed above, PEG fatty acid esters are the reaction products of a PEG compound and a fatty acid. The PEG fatty acid esters of the present embodiment may be as described above with respect to previous embodiments. Generally, it has been discovered that PEG fatty acid esters have adequate cleansing properties and very strong virulence suppression properties. In some embodiments, the surfactants of the cleansing and virulence suppressing compositions of the present disclosure may include one or more PEG compounds having a fatty acid glyceride moiety (also referred to as a PEG fatty acid glyceride). The PEG fatty acid glyceride may be the reaction product of an ethoxylated glyceride and a fatty acid. In some embodiments, the fatty acid is a C8 to C22 fatty acid, and a PEG with 6 to 60 ethylene oxide units. In another embodiment, the peg fatty acid glyceride is a reaction product of a C8 to C18 fatty acid (triglyceride), and a PEG with 6 to 32 ethylene oxide units. In various example embodiments, the PEG fatty acid glcyerides are chosen from PEG glyceryl laurate, PEG glyceryl stearate, PEG glyceryl cocoate, PEG glyceryl caprylate, peg glyceryl oleate, peg glyceryl linoleate, mixtures and combinations thereof. In some embodiments, the PEG fatty acid glycerides may have an HLB value of greater than 8 and less than 18, or greater than 8 and less than 14, or greater than 10 and less than 14. In various embodiments, PEG fatty acid esters may be present in the surfactant in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, between 0.01 wt% and 1 wt%, between 0.01 wt% and 0.5 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the composition (including the aqueous carrier). In some, embodiments, fatty acid containing compounds may be present in the composition in an amount such that the composition does not exhibit antimicrobial properties. In various embodiments, PEG fatty acid glycerides may be present in the surfactant in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, between 0.01 wt% and 1 wt%, between 0.01 wt% and 0.5 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the composition (including the aqueous carrier). In some, embodiments, fatty acid containing compounds may be present in the composition in an amount such that the composition does not exhibit antimicrobial properties. In some embodiments, the surfactants having PEG fatty acid esters and PEG fatty acid glycerides may be present in the cleaning and virulence suppressing compositions of the present disclosure in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, between 0.01 wt% and 1 wt%, between 0.01 wt% and 0.5 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the composition (including the aqueous carrier). It is to be appreciated that the above-described combinations of surfactants being useful in a single solution that both cleanses and suppresses virulence represents a surprising discovery. For example, fatty acid glycerides like glyceryl monolinoleate suppress virulence of S. aureus and have some cleansing properties and Poloxamers like Pluronic F127 are ineffective at virulence suppression and cleanse poorly. However, it was discovered that the combination is excellent for cleansing and virulence suppression. As another example, fatty acid esters of PEG like PEG-12 laurate suppress virulence and surfactants like cocamidopropyl betaine show efficient cleansing. Surfactants at certain (higher) concentrations where cleansing is effective can also kill bacteria. However, it was discovered that the combination of PEG fatty acid esters and surfactants suppresses virulence and cleanses while still allowing for the growth of bacteria. As yet another example, fatty acid esters of PEG like PEG-12 laurate suppress virulence and PEG fatty acid glycerides like stearoyl polyoxyl-32 glycerides do not suppress virulence effectively and both types of chemistries appear to have some cleansing properties. However, it was discovered that the combination of PEG fatty acid esters and PEG fatty acid glycerides cleanses efficiently while still suppressing the virulence of bacteria. In some embodiments, for example, embodiments in which the surfactant includes (i) a polyethylene glycol compound comprising a fatty acid moiety and (ii) a fatty acid containing compound, the pH of the cleansing and virulence suppressing composition may be relatively low in order to facilitate virulence suppression. That is, the pH of the cleansing and virulence suppressing composition may have a pH of less than 6.5, less than 6, or less than 5; and a pH that is greater than 4.5. In some embodiments, the pH may be between 4.5 and 6. Particularly with respect to fatty acid containing compounds, at relatively higher pH values, such compounds have been found not to adequately suppress virulence. At lower pH values, however, such compounds, when used alone, have been found to be unstable. It was discovered that the addition of certain PEG compounds comprising fatty acid moieties impart stability to the fatty acid containing compounds, even at low pH values (e.g., less than 5), without inhibiting the ability of such fatty acid containing compounds to suppress virulence. In some embodiments, for example, embodiments in which the surfactant includes (i) a polyethylene glycol compound comprising a fatty acid ester moiety, and (ii) a polyethylene glycol compound comprising a fatty acid glyceride, the pH of the cleansing and virulence suppressing composition may be from 4.5 to 6.5 or from 5 to 6. In some embodiments, surfactants may be present in the cleansing and virulence suppressing compositions of the present disclosure in an amount of between 0.01 wt% and 10 wt%, between 0.01 wt. % and 2 wt%, or between 0.01 wt% and 1 wt%, or between 0.01 wt% and 0.1 wt%, based on the total weight of the composition (including the aqueous carrier). Conventionally, it was believed that for a single composition to both cleanse and suppress virulence, either metal salts or phosphate containing compounds would need to be present in the composition. It was discovered, however, that the compositions of the present disclosure may adequately cleanse and suppress virulence even in the absence of metal salts or phosphate containing compounds. In this regard, in some embodiments, the compositions of the present disclosure may be free of (or substantially free of) metal salts and phosphate containing compounds. In various embodiments, the aqueous carrier may be present in the cleansing and virulence suppression composition in an amount of between 5 wt% and 99 wt%, between 10 wt% and 98 wt%, between 10 wt% and 95 wt%, or between 10 wt% and 90 wt%, based on the total weight of the composition (including the aqueous carrier). In various embodiments, the aqueous carrier may include at least 80 wt% water, at least 90 wt% water, or at least 95 wt% water, based on the total weight of the aqueous carrier. In some embodiments, the aqueous carrier consists of water, which in this application means that the aqueous carrier is substantially 100 wt% water, or 100 wt% water, based on the total weight of the aqueous carrier. In some embodiments, the aqueous carrier may include an alcohol chosen from benzyl alcohol, phenoxy ethanol, isopropyl alcohol, ethanol, and mixtures and combinations thereof. In various embodiments, alcohol may be present in the virulence suppression composition in an amount of between 0.005 wt. % and 10 wt. %, based on the total weight of the composition (including the aqueous carrier). In some embodiments, the aqueous carrier in the antimicrobial composition may include a humectant. As used herein the term “humectant” refers to polar compounds or mixtures of compounds that act to retain or absorb moisture. Suitable humectants include, but are not limited to, polyols, such as glycerin, propylene glycol, dipropylene glycol, polypropylene glycol, glycerine ethoxylates, methyl glucose ethoxylates, polyethylene glycol, polyethylene / polypropylene glycols, and sorbitol. In some embodiments, the humectants include liquid polar solvents such as for example, monoalkyl glycols, glycerol alkyl ethers, monoacyl glycerols, and mixtures and mixtures and combinations thereof. Suitable examples of the liquid polar solvents include, but are not limited to, glycerol, propylene glycol, polyethylene glycol, pentylene glycol, and mixtures and combinations thereof. In some embodiments, the aqueous carrier can be a mixture of water and a liquid glycol such as, for example, propylene glycol, pentylene glycol and mixtures thereof. For such mixtures, the ratio of water to glycol (or glycols) may be about 1:10 to about 10:1, or about 1:8 to about 8:1, or about 1:5 to about 5:1. Examples of useful aqueous carriers include water and pentylene glycol (2:1), water and propylene glycol (1:2) In various embodiments, liquid glycol may be present in the virulence suppression composition in an amount of between 1 wt% and 30 wt%, or between 1 wt% to about 20 wt%, based on the total weight of the composition (including the aqueous carrier). In some embodiments, the addition of low levels of stabilizing ingredients in the aqueous carrier can also be advantageous. The addition of water-soluble gums such as guar derivatives, xanthan gum, and thickeners such as hydroxy ethyl cellulose, hydroxy propyl cellulose and carboxyl vinyl polymers may be helpful in stabilizing the virulence suppression composition. Suitable oil phase emulsion stabilizers include ethylene / acrylic acid copolymers such as those available under the trade designation AC540 from Allied Signal, Morrison, N.J., and N-vinyl pyrrolidone / olefin copolymers such as that available under the trade designation GANEX V-216 from ISP International Specialty Products, Wayne, N.J. In some embodiments, the aqueous carrier may include predominantly aqueous solutions such as buffers. In some embodiments, the incorporation of thickeners in the composition may delay the release of virulence suppression agents and therefore result in higher concentrations of those agents in the formulation. In this regard, in embodiments in which a thickener is present, metal salts may be present in the virulence suppression compositions in an amount of between 1 μM and 500 μM, between 1 μM and 200 μM, or between 5 μM and 200 μM based on the total volume of the virulence suppression composition. In embodiments in which a thickener is present, phosphates may be present in the virulence suppression compositions in an amount of between 1 mM and 1000 mM, between 5 mM and 700 mM, or between 5 mM and 500 mM, based on the total volume of the virulence suppression composition. In some embodiments, the cleansing and virulence suppressing compositions of the present disclosure (i) may not include any compounds that exhibit antimicrobial activity or (ii) may include compounds that can at certain concentrations exhibit antimicrobial activity, but are present at low enough concentrations such that they do not exhibit antimicrobial activity (i.e., the compositions may allow for microbial growth). For example, the compositions may not include any of the following: chlorhexidine salts; octenidine salts, benzalkonium chloride, parachlorometaxylenol (PCMX); triclosan; hexachlorophene; fatty acid monoesters of glycerin and propylene glycol such as glycerol monolaurate, glycerol monocaprylate, glycerol monocaprate, propylene glycol monolaurate, propylene glycol monocaprylate, propylene glycol monocaprate; phenols; surfactants and polymers that include a C12–C22 hydrophobe and a quaternary ammonium group; polyquaternary amines such as polyhexamethylene biguanide; quaternary silanes; hydrogen peroxide; silver and silver salts such as silver chloride, silver oxide and silver sulfadiazine iodine and its complexed forms, iodine and povidone iodine which are commonly referred to as iodophors. In some embodiments, the cleansing and virulence suppressing compositions can allow for microbial growth. In this regard, in some embodiments, when subjected to the Microbial Kill test, the compositions may demonstrate a log reduction of microbes no greater than 3 logs, no greater than 2 logs, or no greater than 1 log. In some embodiments, the cleansing and virulence suppressing compositions of the present disclosure may include any compounds that exhibit antimicrobial activity at the concentrations in which they are present in the composition. For example, in embodiments that include fatty acid monoesters, such components may be present at concentrations that provide for antimicrobial activity. In this regard,, in some embodiments, when subjected to the Microbial Kill test, the compositions may demonstrate a log reduction of microbes no less than 1 logs, no less than 2 logs, or no less than 3 logs at 24 hours combined with a log reduction of no less than 0.75 for shorter periods. In some embodiments, the cleansing and virulence suppressing compositions can also include components such as, for example, organic solvents, hydrophobic components (e.g., petrolatum and oils), hydrophilic components (glycerin and various ether and / or polyether compounds), silicones, carbohydrates (polysaccharides such as hydroxypropyl methyl cellulose), thickeners such as CARBOPOL, film-formers, emulsifiers, water, organic solvents (e.g., alcohols and polyols), stabilizers (e.g., polymers), fillers (e.g., organic materials such as polymeric particles and inorganic materials including ceramic particles, silica particles, clay particles, and glass particles), emollients / moisturizers, tonicity adjusting agents, chelating agents, anti-inflammatory agents, gelling agents, preservatives, pH adjusting agents, viscosity builders, time-release agents, dyes, fragrances or oils, and the like. In some embodiments, thickeners, such as hydroxypropyl methylcellulose, can be employed to increase the viscosity of the compositions. In general, the polymers useful as thickeners have sufficient molecular weight to achieve thickening at generally less than 5 wt-% polymer, but not too high that the composition feels slimy and stringy. While the composition of the polymer will dramatically affect the molecular weight at which sufficient thickening will occur, the polymers may have a molecular weight of at least 250,000 daltons, or at least 500,000 daltons. The polymers may have a molecular weight of no greater than 3,000,000 daltons or no greater than 1,000,000 daltons. Polymers used to thicken solutions can be classified as soluble, swellable, or associative in the aqueous compositions. Some polymers may fall into one or more of these classes. For example, certain associative polymers can be soluble in the aqueous system. Whether they are considered soluble, swellable, or associative in the aqueous system, suitable polymers may be film forming or not. Film forming polymers may retain the active virulence suppression component at the afflicted site for longer periods of time. This may be desirable for certain applications. For example, some film forming polymers may produce compositions that could not be easily washed off with water after being applied and dried. As used herein, a soluble polymer is one that in dilute solution (i.e., 0.01-0.1 wt-% in the desired aqueous solvent system defined as containing water and any other hydrophilic compounds), after heating for a sufficient time to ensure solubilization of any potentially soluble components, has no significant observable particles of greater than 1 micron in particle size, as determined by light scattering measurements using, for example, Malvern Masterisizer E Laser Particle Size Analyzer available from Malvern Co., Boston, Mass. As used herein, a swellable polymer is one that in dilute solution (i.e., 0.01-0.1 wt-% in the desired aqueous solvent system), after heating for a sufficient time to ensure solubilization of any potentially soluble components, has a significant (i.e., detectable) number of observable particles of greater than 1 micron in particle size, as determined by light scattering measurements using, for example, Malvern Masterisizer E Laser Particle Size Analyzer. In some embodiments, the cleansing and virulence suppressing compositions may be suitable for treating any known microbe including, for example, bacteria, viruses, fungi such as Candida, and mycobacteria. In particular, administering the medical composition can suppress virulence of at least one of gram negative Pseudomonas aeruginosa, gram positive Enterococcus faecalis, gram positive Staphylococcus aureus, or gram negative Serratia marcescens. Unlike some previously known methods of treating microbial infections, the cleansing and virulence suppression compositions of the present disclosure do not substantially kill all microbes within the treatment area. Although some of the pathogens may be destroyed at the treatment site such as those associated with a biofilm, colonization of the protective microbes is not substantially reduced. Stated differently, the pathogens can be contained and controlled while the colonization resistance of the non- pathogenic microbes and / or the normally protective microbes can be preserved. As used in reference to reduction in the number of microbes that are present, the term “substantially” means that there is less than 1 log reduction of the microbes. In some embodiments, there may be in increase in the growth of protective microbes. In some embodiments of administering the cleansing and virulence suppressing compositions, the virulence factor is reduced by at least 50 percent, at least 60 percent, at least 70 percent, at least 75 percent, at least 80 percent, at least 90 percent, at least 95 percent, at least 99 percent, at least 99.5 percent, or at least 99.9 percent when compared to the vehicle only control. The percentage can be based on weight, area, volume, or any other suitable measurable amount. In some embodiments, the cleansing and virulence suppressing compositions can be administered and / or applied in various formulations such as a gel (e.g., cellulosic gel), a spray, lotion, ointment, solution, emulsion, dispersion, foam, coating, paste, powder, tablet, capsule, or the like. The formulation used can be chosen based upon the location of the infection or potential infection and on the desired delivery method. In some embodiments, the cleansing and virulence suppressing compositions can be administered and / or applied in any desired formulation such as a spray, lotion, ointment, gel, solution, emulsion, dispersion, foam, coating, paste, powder, tablet, liquid, capsule, a drink or the like. The formulation used is dependent on the location of the infection or potential infection and on the desired delivery method. For some applications, it is desirable that the cleansing and virulence suppressing compositions remain in a location where they are administered and / or applied. Such compositions are usually formulated to have a suitably high viscosity and / or to include a hydrophobic component that will enhance retention of the composition at the application location. These formulations can be, for example, an emulsion, ointment, gel, or lotion. Emulsions can be oil-in-water or water-in-oil. By suppressing virulence, administration and / or application of the medical compositions can be used to prevent, mitigate, or treat a microbial infection. In some embodiments, a method of cleansing and suppressing microbial virulence using a single solution is provided. Cleansing may be carried out by physical removal of, for example, microbes and debris, by contacting (e.g., rinsing) with the solution. The microbial virulence may be suppressed by reducing or inhibiting the synthesis and / or expression of one or more virulence factors by the microbe. By suppressing the synthesis and / or expression of one or more virulence factors, a microbial infection can be prevented, mitigated, or treated. The method includes administrating and / or applying any of the above- discussed virulence suppression compositions. Any suitable method of administering and / or applying the cleansing and virulence suppressing compositions can be used. For example, the compositions can be applied to skin, mucosa, tissue (both exterior and interior surfaces of tissue), a wound site, a surgical site, an implant (e.g., knee and hip replacement, pacemaker, heart valve, or stent), a catheter, a suture, or a bone or the gut. Alternatively, or additionally, the compositions may be ingested. The cleansing and virulence suppressing compositions can be administered and / or applied locally or systemically. For example, the cleansing and virulence suppressing compositions can be applied using a discharge applicator (e.g., spray applicator, squeezable container), swab, cloth, sponge, nonwoven wipe, paper product such as a tissue or paper towel, or the like. When applied locally, in some embodiments, the composition may remain where it was applied. In other embodiments, after the application is applied (to, for example a wound or surgical site), an additional rinse step may be carried out with a second (conventional) cleansing solution (e.g., saline). In this regard, surprisingly, it was discovered that even after a second rinsing step, appreciable amounts of the cleansing and virulence suppression compositions of the present disclosure remain bound to the relevant surface (e.g., tissue within or near a wound or surgical site) in an amount sufficient for the virulence suppression properties of the compositions to be maintained. In some embodiments, the methods may include introducing the composition at a relatively high pH (to, for example, maximize the cleansing property of the composition) and for maximum cleansing and then reducing (by passage of time or the introduction of a saline rinse) the pH of the composition (to, for example, maximize the virulence suppressing property of the composition). In other examples, the compositions can be administered orally or intravenously. For some infections, such as those that are initiated in the gut, the compositions can be administered by drinking a solution or by swallowing a tablet or capsule. The cleansing and virulence suppressing compositions can be administered and / or applied to reduce or prevent biofilm attachment on various surfaces. For example, the compositions can be applied to implants and catheters prior to their insertion into a mammalian body. In other examples, the compositions can be applied to bedding, surgical tables, tubing used in medical procedures, and other reusable medical equipment that contacts a mammal. In yet other examples, the compositions can be a liquid composition that is used to control or prevent biofilm populations in oral applications, such as for treating gingivitis. In still other examples, the compositions can be used to control or prevent biofilm populations in the middle ear that have been found in chronic otitis media. In yet other examples, the compositions can be used to control or prevent biofilm populations in the nose, which can result in the prevention or treatment of various infections such as those in the lungs and in blood. The compositions can often impact virulence factors either before or after biofilm formation. In some embodiments, the cleansing and virulence suppressing compositions are suitable for preventing and treating urinary tract infections (e.g., administered in the form of a drink), ventilator associated pneumonia (e.g., administered in the form of a drink, tablet, or capsule), implant infections (e.g., administered by application as a coating on the implant), wounds (e.g., administered by application of a coating on the wound, whether chronic or acute), bloodstream infections (e.g., administered and / or applied to the blood-contacting tissue), mucosal tissue infections (e.g., administered in the nose), gastrointestinal tract (administered in the form of a coating, drink, tablet, or capsule), vaginal tissue (e.g., administered in the form of a coating), anastomotic tissue (e.g., administered as a coating on the surgical site to prevent anastomotic leaks), peritoneum (e.g., administered at the surgical site), sepsis, and the like. In some embodiments, where this is an existing microbial infection, the compositions may be applied over the area where the microbes are located. In some embodiments, the cleansing and virulence suppressing compositions may be administered in a therapeutically effective amount. This refers to the amount of the composition that is needed to inhibit the synthesis and / or expression of one or more virulence factors by a microbe or that is enough to reduce, mitigate, or prevent a microbial infection. In some embodiments, administering the cleansing and virulence suppressing compositions may suppress at least one type of virulence factor. That is, the compositions may suppress the formation or expression of various molecules that may be harmful to the mammal and / or suppresses the formation of biofilms on a foreign object such as an implant suture in the mammal. For example, the compositions can suppress the formation or expression of pyocyanin, pyoverdine, collagenase (which is often measured by breakdown of gelatin as a surrogate of collagenase activity), hemolysins, and biofilms by bacteria. The compositions may suppress, for example, the agr (accessory gene regulator) quorum sensing system in Staphylococcus aureus. In some embodiments, the cleansing and virulence suppressing compositions may be supplied in the form of a kit including a container of the composition and an applicator that can be used to apply the composition to the skin. In some embodiments, the container may be a squeezable bottle or a collapsible tube, along with instructions for proper application to a treatment site or to the included applicator. In some embodiments, the kit may be supplied in sterile form in a tray, and may optionally include the application instructions along with a surgical incise drape. In some embodiments, the tray and drape may be packaged for a selected medical or surgical procedure. In some embodiments, cleansing and virulence suppressing compositions can be easily manufactured and scaled up into industrial scale production. The composition can be formed as the ingredients are combined and mixed together, even in the absence of high shear conditions or pressure homogenization. Therefore, the composition may be prepared using any standard mixing equipment which is suitable for the preparation of liquid pharmaceutical formulations at the appropriate scale. Optionally, ultrasound treatment of the combined ingredients may be used to accelerate formation. In some applications, the composition could include an FDA acceptable dye and in other cases, the dye could be separated from the composition within the applicator. Objects and advantages are further illustrated by the following examples, but the particular materials and amounts thereof recited in these examples, as well as other conditions and details, should not be construed to unduly limit the present disclosure. Unless otherwise indicated, all parts and percentages are on a weight basis. EXAMPLES Materials Table 1: Materials. Description (Abbreviation) Source 2X T Y M di 2X TY Si Ald i h C i S L i MO es, TOSI strips Healthmark Industries, Fraser, MI T t th d f l i . , ally available cleaning verification test made of stainless steel with dried blood soil. The metal strips come in a plastic holder which is removed before testing. Twenty milliliters of the properly diluted solution was added to a 25 mL glass vial. One TOSI strip was added to each vial and the vial was capped. All the vials were attached to a vial rotisserie rotator set at 15 rotations per minute and rotated for two minutes. After two minutes each TOSI strip was removed and left to dry at ambient conditions. After they were dry, all of the TOSI strips were rated in comparison to the control. Agr Reporter (Staph aureus) Assay Description: The expression of many virulence factors in Staphylococcus aureus is controlled by the quorum sensing accessory gene regulator (agr) system. The plasmid pJY202 is an agr reporter that contains a fusion of the agr P2-P3 region with a gene coding for GFP. An S. aureus MN8 (pJY202) colony was picked from a TSA plate and grown overnight in TSB media with 5 µg / mL erythromycin with shaking at 37°C.^ The culture was centrifuged at 3000 x g for 5 minutes and the supernatant was removed.^ The bacteria were washed once with water. Individual growth media solutions for the assay were freshly prepared by adding materials as provided in Table 3 to 1X TY media with 5 µg / mL erythromycin and then adjusting the pH of each solution to about pH 6.0 (using 1M NaOH or 1M HCl).^ All the growth media solutions were sterile filtered when possible using a 0.2 micrometer filter. An aliquot of each growth media solution (200 microliters) was added to the well of a 96-well black, clear-bottom plate. Samples were prepared in triplicate (n=3).^ The bacteria samples were resuspended in 5 mL of 1X TY media.^ A 3 microliter sample of resuspended S. aureus MN8 (pJY202) was added to each well. Background control wells were also prepared that did not have bacteria added to the wells.^ Bacterial growth was measured at 600 nm (OD600) and Agr activity was measured as fluorescent intensity at 485 nm excitation / 528 nm emission.^ Agr activity (relative fluorescence units, RFU) was normalized to bacterial growth (OD600) for each well. The Agr activity was measured at the 24 hour time point. Hemolysis Assay Description: Some strains of Staphylococcus aureus release hemolysins, which can break down red blood cells and are involved in the pathogenesis of S. aureus infections. An S. aureus 6538 colony was picked from a TSA plate and grown overnight in TSB media with shaking at 37°C.^ The culture was centrifuged at 3000 x g for 5 minutes and the supernatant was removed.^ The bacteria were washed once with water. Individual growth media solutions for the assay were freshly prepared by adding materials as provided in Table 2 to 1X TY media and then adjusting the pH of each solution to about pH 6.0 (using 1M NaOH or 1M HCl).^ All the growth media solutions were sterile filtered when possible using a 0.2 micrometer filter. An aliquot of each growth media solution (200 microliters) was added to the well of a 96-well black, clear-bottom plate. Samples were prepared in triplicate (n=3).^ The bacteria samples were resuspended in 5 mL of 1X TY media.^ A 3 microliter sample of resuspended S. aureus 6538 was added to each well. Background control wells were also prepared that did not have bacteria added to the wells.^ Bacterial growth was measured at 600 nm (OD600). At 24-28 hours, cultures from wells receiving the same treatment were combined into microcentrifuge tubes. The tubes were centrifuged at 10,000 rpm for 5 minutes. The supernatant was added to an equal volume of whole porcine blood in a fresh microcentrifuge tube. The tubes were mixed and incubated at 37°C for 1 hour. After 1 hour, the tubes were centrifuged at 3000 rpm for 5 minutes. The supernatants were diluted 1:20 with water and put in a fresh 96-well plate. The absorbance was measured at 543 nm. Hemolysis values (absorbance at 543 nm) was normalized to growth (background-subtracted OD600 measured at the final time point of the culture prior to testing for hemolysis). Material / media controls were included to check if the materials were hemolytic on their own. Biofilm Formation Assay Using Crystal Violet Staining Description: Crystal violet staining is commonly used to evaluate biofilm formation. An S. aureus 6538 colony was picked from a TSA plate and grown overnight in TSB media with shaking at 37°C.^ The culture was centrifuged at 3000 x g for 5 minutes and the supernatant was removed.^ The bacteria were washed once with water. Individual growth media solutions for the assay were freshly prepared by adding materials as provided in Table 2 to 1X TY media and then adjusting the pH of each solution to about pH 6.0 (using 1M NaOH or 1M HCl).^ All the growth media solutions were sterile filtered when possible using a 0.2 micrometer filter. An aliquot of each growth media solution (200 microliters) was added to the well of a 96-well black, clear-bottom plate. Samples were prepared in triplicate (n=3).^ The bacteria samples were resuspended in 5 mL of 1X TY media.^ A 3 microliter sample of resuspended S. aureus 6538 was added to each well. Background control wells were also prepared that did not have bacteria added to the wells.^ Bacterial growth was measured at 600 nm (OD600). At 24-28 hours, the solutions were aspirated from wells. Each well was washed two times with water (200 microliters per well) and then stained with 200 microliters of 0.1% aqueous crystal violet solution for 5 to 10 minutes. The crystal violet solution was then aspirated from each well and the wells were washed four times with water (200 microliters per wash per well). The remaining crystal violet stain in each well was solubilized with 200 microliters ethyl alcohol and then transferred to a well in a fresh 96-well plate. The absorbance of each well was measured at 550 nm and normalized to growth (background-subtracted OD600 measured at the final time point of the culture prior to testing for biofilm formation). Time kill evaluation Description: Time kill is used to assess antimicrobial activity of a test compound. ASTM E2315-16 was used with the following specifications. Bacterial strain S. aureus Xen36 was grown overnight in 1X TY media with shaking at 37°C. The bacterial culture was diluted in 1X YT media to a concentration of 5 x 108colony forming units per mL, approximately 0.6 OD600.0.05 mL of bacterial suspension was added to 1 mL of test formulation. At the end of each time interval, 0.1 mL was added to 12.5 mL of Dey-Engley neutralizing broth (DE broth) and vortexed to neutralize. Serial dilutions were prepared and plated onto TSA plates. Example 1: Virulence suppression and cleansing using formulations containing low concentrations of fatty acids and peg fatty acid glycerides: To create test solutions, reagents were added to TY medium at the concentrations provided under Final Concentration in Table 2 at 1X TY. All percentages are by weight unless noted otherwise. The test solutions were used in the assays described above and the results are provided in Table 2. In the evaluation of TOSI strips, LOW is defined as visibly worse than the control, MEDIUM is defined as visually similar to the control., and HIGH is defined as visibly better than the control. The data in Table 2 shows that PEG 12 laurate and GELUCIRE 50 / 13 in combination show a synergistic cleansing effect while maintaining virulence suppression. Also, the combination of CAPMUL 808G and MYRJ S40-NV-PA has better virulence suppression due to biofilm than either compound by itself. The combination of PEG 12 laurate and PEG 20 glyceryl laurate has better cleansing than the individual compounds while maintaining virulence suppression. It is expected that compounds that do not significantly inhibit bacterial growth, such that their Growth (%of TY control) in Table 2 is greater than 50%, will have less than 1 log reduction in the Time Kill method. Table 2: Virulence suppression and cleansing results. Xen36 pJY202 SA6538 ng ) ed 0.05% MYRJ S40-NV-PA 102% 102% 129% 68% 101% Low 0.05% CAPMUL 808G, 69% 1% 76% 45% 29% M di m Porcine mucosal model (PMM) efficacy assay protocol: 1. Tissue Preparation Porcine vaginal mucosal tissue was scrubbed and rinsed with tap water. Then, 5-mm diameter biopsy explants were created, transferred into RPMI 1640 media + 2% penicillin / streptomycin (P / S), trimmed, and sonicated for 2.0 ± 0.1 minutes. Tissue explants were incubated for 15 minutes in RPMI 1640 media + 2% P / S. Media was replaced with RPMI 1640 media with no antibiotics and washed 3 times. Explants were incubated in antibiotic free RPMI 1640 media for 30 minutes. Wells of a 6-well plate were filled with 2.0 ± 0.1 mL RPMI 1640 media (no antibiotics, no fetal calf serum) and a transwell insert. The tissue explants were transferred to the transwells with epidermis side up (5 explants / well). 2. Infection (S. aureus 6538) A fresh petri plate was streaked directly from the bacterial test organism (S. aureus 6538) from frozen stock within one week of the experiment. A culture tube containing 5 mL Tryptic Soy Broth (TSB) was inoculated with multiple colonies and placed in a shaking incubator (37°C, 200 rpm) late in the afternoon on the day before the experiment. On the morning of the experiment, 20 ± 5 μL bacteria was passaged into 2 mL fresh TSB and grown for 3 ± 1 hours. The optical density of the culture was measured at 600 nm for which a reading of 0.6 corresponded to ~5x108colony forming units per milliliter (CFU / mL). Dilutions were prepared in RPMI 1640 media such that 1 mL contained ~5x108CFU. 3. Treatment Treatment solutions were prepared according to Table 3 by mixing the test compounds at the indicated weight percentage with normal saline. A fixed volume (100 µL) of each treatment solution was applied to the tissue explant. In some cases, as indicated in Table 3, after a 3 min wait time, the tissue was rinsed with 200 µL of normal saline. In other cases, the excess liquid was aspirated after a 3 min wait time, and the media was replaced. The tissue was then infected with 2 µL of S. aureus 6538. The treated bacteria- inoculated explants were incubated at 37 ± 2°C for 30 minutes and then 100 µL of the same treatment solution was applied to the tissue explant. After 3 minutes, the tissue was rinsed with 200 µL of normal saline. The excess liquid was aspirated and media was replaced. The explants were incubated at 37°C for 1 hour and 24 hours. 4. Sampling / Counting Three of the explants were used for bacterial enumeration and 2 of the explants were removed from transwells and placed in epitubes of 500 µL Zymo. Bacterial enumeration explants: The explants were removed from the transwells and placed into microcentrifuge tubes containing 1 mL 2X DE broth neutralizer. Bacteria were liberated using a vortex / sonicate / vortex protocol (30 ± 5 seconds vortex, 2 ± 0.5 minutes sonicate, 30 ± 5 seconds vortex). Bacteria were plated (using a spiral plater) onto MSA plates (diluted in PBS if necessary). Plates were incubated overnight at 37°C with ambient CO2. Testing of the samples was done in triplicate,. First, log10 CFU / mL for saline treatment and corresponding treatment groups was determined following 30 min or 1 h and 24 h exposures. Then the mean log reductions were determined by subtracting the mean Log10 CFU / mL saline – mean log 10 CFU / mL treatment group (from the same day and same time point). This procedure may be referred to as the Microbial Kill Test. Virulence suppression explants: The explants were removed from the transwells and placed into microcentrifuge tubes containing 500 µL Zymo (RNAlater). Bacteria were liberated using a vortex / sonicate / vortex protocol (30 ± 5 seconds vortex, 2 ± 0.5 minutes sonicate, 30 ± 5 seconds vortex). Explants were removed from tubes using sterile forceps. One mL of RNAprotect bacteria reagent was added to each sample and incubated at room temperature for 5 minutes. Samples were centrifuged for 10 minutes at 5000 x g. The supernatant was decanted and 100 µL of 100 µg / mL lysostaphin was added to each sample and incubated at room temperature for 10 minutes. Next, 700 µL of RLT (lysis) buffer with 10 µl / mL 2- mercaptoethanol was added to each sample. Samples were transferred to 2 mL Safe-Lock tubes containing 25-50 mg of acid washed glass beads (150-600 µM diameter) and vortexed horizontally at max speed (3000 rpm) for 10 minutes. Samples were then centrifuged briefly to pellet beads. Supernatants were transferred to fresh microcentrifuge tubes and 590 µL of 80% ethanol was added to each. RNA was then purified using the Qiagen RNeasy Mini Kit following kit instructions. cDNA was synthesized using the High-Capacity cDNA Reverse Transcription Kit, following kit instructions. Quantitative polymerase chain reaction (qPCR) was performed using gene specific primers and SYBR green detection chemistry. Analysis was performed using the 2-ΔΔCtmethod to determine relative gene expression with 16S as the housekeeping gene. In general, agr and hla values were decreased at lower pH, meaning better virulence suppression. Initially, at 30 minutes or 1 hour, bacterial recovery of samples treated with test compounds are lower (better bacterial kill) compared to the betadine control in many cases. Bacterial recovery remained lower for treatment groups compared to the betadine control at 24 h post treatment. Table 3: Effect of test compounds in a porcine mucosal model. Log Virulence Virulence Log reduction suppressio suppression rd ti n ing m m m IRE 44 / 14, laurate, pH No Data 2.2 -4.81 -4.95 Stable Medium m m m

Claims

CLAIMS What is claimed is:

1. A stable composition for cleansing and suppressing microbial virulence comprising: (a) a surfactant comprising (i) a polyethylene glycol compound comprising a fatty acid moiety, and (ii) a fatty acid containing compound; and (b) an aqueous carrier; wherein the surfactant is present in an amount of between 0.01 and 1 wt. %, based on the total weight of the composition; and wherein the composition does not comprise a phosphate containing compound or a metal salt.

2. A stable composition for cleansing and suppressing microbial virulence comprising: (a) a surfactant comprising (i) a polyethylene glycol compound comprising a fatty acid ester moiety, and (ii) a polyethylene glycol compound comprising a fatty acid glyceride; and (b) an aqueous carrier; wherein the surfactant is present in an amount of between 0.01 and 1 wt. %, based on the total weight of the composition; and wherein the composition does not comprise a phosphate containing compound or a metal salt.

3. The composition of any one of the previous claims, wherein the surfactant has an HLB value of greater than 8 and less than 16.

4. The composition of any one of the previous claims, wherein the composition has a pH of less than 6.

5.

5. The composition of any one of the previous claims, wherein the surfactant is present in an amount of between 0.1 and 1 wt. %, based on the total weight of the composition.

6. The composition of any one of claims 1-5, wherein the composition, when subjected to the Microbial Kill test, demonstrates a log reduction of microbes of greater than 1 log at 24 hours.

7. The composition of any one of the previous claims, wherein the composition does not comprise chlorhexidine salts, iodine or iodophors, octenidine salts, benzalkonium chloride, parachlorometaxylenol, triclosan, hexachlorophene, fatty acid monoesters of glycerin and propylene glycol, surfactants and polymers that include a C12–C22 hydrophobe and a quaternary ammonium group, polyquaternary amines, quaternary silanes, hydrogen peroxide, or silver or silver salts or complexes 8. The composition of any one of the previous claims, wherein the composition further comprises a thickening agent.

9. The composition of any one of claims 1 or 3-8, composition of any one of the previous claims, wherein the polyethylene glycol compound comprising a fatty acid moiety comprises a PEG alkyl ester, a PEG alkyl ether, a PEG alkyl amides, or a PEG 1,2 diols, and wherein the alkyl group on any of the PEG compounds is independently selected to have 8 to 22 carbon atoms.

10. The composition of any one of claims 1 or 3-8, wherein the fatty acid containing compound comprises an ester, an ether, an amide, or a monoalkyl glycols, having an alkyl group that includes from 8 to 22 carbon atoms.

11. The composition of any one of the previous claims, wherein the composition is included in a solution, spray, lotion, ointment, gel, solution, emulsion, dispersion, foam, coating, paste, powder, tablet, adhesive, or capsule.

12. A method of cleansing and suppressing microbial virulence, the method comprising administering and / or applying the composition of any one of claims 1-11.

13. The method of claim 12, wherein administering and / or applying the composition suppresses at least one virulence factor.

14. The method of claim 13, wherein the virulence factor is AgrA expression, hemolysin, biofilm, pyoverdine or collagenase.

15. The method of any one of claims 12-14, wherein administrating and / or applying the composition comprises applying the medical composition to skin, mucosa, tissue, a wound site, a surgical site, an implant, the gut, catheter, suture, or a bone.

16. The method of any one of claims 12-15, wherein administrating and / or applying the composition reduces or inhibits virulence of at least one of gram negative Pseudomonas aeruginosa, gram positive Enterococcus faecalis, gram positive Staphylococcus aureus, or gram negative Serratia marcescens.

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