Prebiotics, probiotics and / or postbiotics treatment agents, ostomy barriers and adhesives, and methods for improving the health of the skin around the stoma

Abstract

The ostomy barrier, skin adhesive, accessory, or peristomal skin treatment comprises a population of non-pathogenic bacteria, fungi, algae, yeasts, or lysates thereof configured to limit the growth of pathogenic organisms in or on the peristomal skin or other body site skin and / or maintain a healthy skin flora. The ostomy barrier, adhesive, accessory, or peristomal skin treatment may also be configured to alter the peristomal or other skin environment to inhibit the growth of pathogenic organisms while promoting the growth of desirable or commensal populations.

Description

Technical Field

[0001] The present disclosure relates to skin adhesives and methods and devices for peristomal skin care in ostomy, and more particularly to ostomy barriers, adhesives, accessories and treatment agents that introduce, maintain and / or promote the growth of bacteria or single-celled eukaryotes that are less pathogenic than pathogenic bacteria or corrosive fungi.

Background Art

[0002] Skin adhesives are used to secure a transcutaneous interface to the body for a wide variety of medical devices and wearable sensor technologies. One example is an ostomy barrier, which is used to secure an ostomy appliance, such as an ostomy pouch, to the skin around the user's stoma, i.e., the "peristomal skin". Typically, current ostomy barriers include a skin barrier formed from an adhesive, a backing layer, and an inlet opening for receiving the stoma. The ostomy barrier can be attached to an ostomy pouch for a one-piece pouch system. Alternatively, the ostomy barrier can be configured as a faceplate for a two-piece pouch system that includes a body-side coupling configured to engage a pouch-side coupling attached to the ostomy pouch. Ostomy accessories are used with the ostomy barrier and help with the proper "wearing" of the barrier, including attachment, sealing, removal and reapplying.

[0003] An ostomy barrier may remain attached to a user's skin for an extended period of time to secure an ostomy pouch. The peristomal skin environment under the ostomy barrier is warm, dark, and moist and may be intermittently soiled by urine, feces, or other excreta, providing an ideal situation for the growth of microorganisms that can lead to dysbiosis and / or infection of the peristomal skin. Studies have found that swabs of peristomal skin show infections by various viruses, bacteria, and fungi, as well as colonization by bacterial and fungal microorganisms. Reported adverse effects of infections by pathogenic species include impairment of re-epithelialization and cell migration, as well as epidermal viability, which can affect the healing of peristomal skin complications and pathologies. Additionally, many ostomy patients may be immunosuppressed due to co-morbidities including, but not limited to, diabetes, adjuvant cancer therapy / chemotherapy, or immunosuppressive / immunomodulatory agents used in the treatment of inflammatory bowel disease, which may further increase the risk of peristomal infections and other complications.

[0004] A microbiome is the collective genomic population of microorganisms in a particular environment, such as the human body or a part of the body, and its influence on health and disease is an area of active research. Probiotics have been used, for example, in the gastrointestinal tract and in topical skin care formulations for acne, atopic dermatitis, and other pathologies, to selectively promote the growth of non-pathogenic microorganisms over pathogenic microorganisms. Non-pathogenic microorganisms are hypothesized to change the environment and / or compete with pathogenic microorganisms, reducing their relative proportion in the overall population. Additionally, differential culture media, nutrients, and / or conditions have been widely used historically for the identification and / or isolation of microorganisms and are well characterized in the literature. Using the same media, nutrients, and / or conditions, specific bacterial, fungal, and / or viral species can be selectively promoted or inhibited over others.

[0005] The present disclosure provides improved skin adhesives, ostomy barriers, appliances, accessories, and peristomal treatment agents that include components and / or conditions that selectively promote and / or maintain non-pathogenic bacteria, fungi, algae, and / or healthy peristomal skin.

SUMMARY OF THE INVENTION

[0006] A peristomal skin treatment agent, ostomy accessory, ostomy appliance, skin adhesive, or ostomy skin barrier may be configured to introduce selected species of non-pathogenic bacteria, fungi, algae, or yeast, or to modulate an existing bacterial population, or to preferentially select certain non-pathogenic microorganisms over others, or to foster their growth, so as to promote the health of peristomal skin, according to various embodiments.

[0007] In one aspect, a skin adhesive or ostomy barrier can include a skin barrier or adhesive and a population or lysate of non-pathogenic bacteria, fungi, algae, or yeast configured to limit the growth of pathogenic organisms within or on the peristomal skin or to maintain a healthy skin microbiota. The population or lysate of non-pathogenic bacteria, fungi, algae, or yeast can be selected, for example, but not limited to, from the group consisting of the genus Lactobacillus, Lactobacillus plantarum, other lactic acid bacteria, and the genus Bifidobacterium, and lysates thereof.

[0008] The skin adhesive or ostomy barrier can further include a nutrient medium configured to promote the growth of a population of non-pathogenic bacteria, fungi, algae, or yeast while inhibiting the growth of pathogenic organisms. In one embodiment, the ostomy barrier or adhesive can include a resealable opening or port for introducing the nutrient medium.

[0009] In one embodiment, a population or lysate of non - pathogenic bacteria, fungi, algae, or yeast can be provided on the skin - facing surface of a skin barrier adhesive or incorporated into a barrier or adhesive formulation. For example, a population of non - pathogenic bacteria, fungi, algae, or yeast can be provided on a release liner, and the release liner can be laminated to a skin barrier or adhesive and transferred to the skin - facing surface of the skin barrier or adhesive when removed prior to use.

[0010] In one embodiment, an ostomy barrier or skin adhesive can be configured to create an anaerobic environment that depletes oxygen or provides an airtight stoma - surrounding region, limiting the growth of aerobic bacteria while allowing the growth of anaerobic bacteria. Alternatively, an aerobic environment can be provided to limit the growth of anaerobic bacteria. In another embodiment, an ostomy barrier or adhesive can be configured to maintain a stoma - surrounding skin temperature of about 38°C to 48°C using an integrated heating element. A heating pad thereon can be utilized to provide selective temperature conditions. In yet another embodiment, an ostomy barrier or adhesive can be configured or formulated to control the humidity and / or pH of the stoma - surrounding skin region within a selected range to promote the growth of a population of non - pathogenic bacteria, fungi, algae, or yeast while inhibiting the growth of other organisms or pathogenic organisms. Buffer conditions for maintaining a specific pH that promotes a healthier skin microbiota than introduced (e.g., enteric or fecal bacteria) or pathogenic species may also be included.

[0011] In another aspect, a stoma - surrounding skin treatment agent, ostomy accessory, or skin adhesive can include a lysate or population of non - pathogenic bacteria, fungi, algae, or yeast that is configured to limit the growth of pathogenic organisms in / on the stoma - surrounding skin.

[0012] In some embodiments, a population or lysate of non-pathogenic bacteria, fungi, algae, or yeast may be included in a degradable polymer microsphere or protein carrier, and the degradable polymer microsphere or protein carrier may be configured to degrade or disintegrate upon exposure to a specific range of ionic conditions or a specific range of pH, or in the presence of endogenous proteases or pancreatic proteases known to be present in the excreta of ileostomy and colostomy. In one embodiment, the population of non-pathogenic bacteria, fungi, algae, or yeast may be incorporated and immobilized in a water-soluble carrier formed from polyvinyl alcohol or gelatin or other functional polymers that provide a favorable environment. In one embodiment, the ostomy accessory or peristomal skin treatment agent may be provided as a stoma powder or paste. In some embodiments, the peristomal skin treatment agent, ostomy accessory, or skin adhesive may further include a protease inhibitor such as ethylenediaminetetraacetic acid (EDTA).

[0013] In yet another aspect, a method of improving or maintaining the health of peristomal skin may include applying a lysate or population of non-pathogenic bacteria, fungi, algae, or yeast to the peristomal area or other skin site via a vehicle, and attaching an ostomy barrier or adhesive, each configured to promote the growth of the population of non-pathogenic bacteria, fungi, algae, or yeast.

[0014] In one embodiment, the lysates and / or populations of non-pathogenic bacteria, fungi, algae or yeast may be provided in a liquid form that can be sprayed or applied to the peristomal skin or other skin sites, or in the form of a gel, paste or powder. The adhesive or ostomy barrier can include a nutrient medium configured to promote the growth of populations of non-pathogenic bacteria, fungi, algae or yeast while inhibiting the growth of pathogenic organisms. In one embodiment, the adhesive or ostomy barrier is configured to change at least one aspect of the peristomal skin, such as nutrition, oxygen supply, ion concentration, temperature, moisture content, humidity or pH, in order to promote the growth of populations of non-pathogenic bacteria, fungi, algae or yeast while inhibiting the growth of selected pathogenic organisms.

[0015] In one embodiment, the adhesive or ostomy barrier may incorporate solid, gel and / or liquid additives to regulate the microclimate humidity. For example, desiccants or vapor pressure regulating additives may be incorporated into the ostomy barrier, enabling the regulation of humidity within the peristomal skin microenvironment. The barrier can be tailored to specific humidity conditions by the selection of different additives and / or desiccants, and their proportions within the barrier. Additional humidity specifications can be extended by combinatorial mixtures of additives with different chemical identities and proportions within the barrier. In another embodiment, the humidity regulating adhesive, skin protectant or device can be applied as an accessory for peristomal care. Humidity regulation can be customized for the promotion of the growth of beneficial microbial populations, the inhibition of pathogenic organisms, or a combination thereof.

DETAILED DESCRIPTION OF THE INVENTION

[0016] The present disclosure is applicable to various forms of embodiments, but presently preferred embodiments are described below. Here, it is understood that the present disclosure is considered illustrative and is not intended to be limited to the specific embodiments illustrated.

[0017] The human skin microbiome varies by anatomical site due to microclimates, such as dry, sebum, and moist microclimates. Surgically created apertures can disrupt the intestinal and / or skin microbiomes to varying degrees and potentially alter the indigenous microbiomes therein. Further, the apertures can create unique microclimates at the interface between the skin and the intestine for potentially unique dysbioses of the mixed skin / intestinal microbiome. The present disclosure discloses methods and devices for maintaining, modulating, or varying an ostomy environment to maintain and / or re-establish the health of the skin surrounding a stoma, according to various embodiments.

[0018] Probiotics, as used herein, are live microorganisms administered to confer a health benefit on a host. The health benefits of probiotics can vary depending on the bacterial strain, the method of delivery or application, and the clinical condition.

[0019] Prebiotics, as used herein, are compounds or ingredients that can selectively stimulate the growth and / or activity of one or more strains of microorganisms beneficial to the health of the host.

[0020] Postbiotics, as used herein, refer to soluble factors (products or metabolic by-products), such as enzymes, peptides, teichoic acids, muropeptides derived from peptidoglycan, polysaccharides, cell surface proteins, and organic acids, that are secreted by live microorganisms or released after lysis of the microorganisms.

[0021] In the present disclosure, monoculture is described for simplicity, but co-culture or multiplex culture of two or more bacterial species, fungi, algal species, or combinations thereof can also be used.

[0022] In one embodiment, a peristomal skin treatment agent (e.g., a skin protectant, skin conditioner, lotion, liquid, etc.) or an ostomy appliance or accessory (e.g., an ostomy barrier, stoma ring, stoma powder, etc.) can be configured to deliver a single bacterial species or mixture of bacteria, or a single lysate or mixture of lysates, either once or in sequence, to maintain and improve the health of the peristomal skin. The bacteria can be in various forms, such as a suspended form (e.g., in a liquid suspension that can be sprayed, applied, or injected onto the skin), a lyophilized powder, and / or spores immobilized on a solid substrate, such as a hydrophilic colloid or other biomaterial-containing ostomy barrier, that can be applied to the peristomal skin and isolate the skin from ostomy effluent. Examples of genera of microorganisms suitable for application to the peristomal skin include, but are not limited to, Lactobacillus, Lactobacillus plantarum, lactic acid bacteria, and Bifidobacterium or lysates thereof. Such microorganisms are currently used as over-the-counter (OTC) probiotics and are therefore readily available. Many other bacterial species, fungal species, and eukaryotic species, including algae, such as Staphylococcus and / or Streptococcus, may also be suitable for application to the peristomal skin.

[0023] A bacterial culture or inoculum of non-pathogenic bacteria, or a lysate thereof, is applied to the at-risk, irritated, lacerated, colonized or infected skin around the stoma, competitively colonizes that area, and can prevent the attachment, colonization and growth of pathogenic bacteria. Examples of application methods can include sprays, swabs, dressing-fixed cultures or spore strips. In some embodiments, selective nutrients or conditions for the selected non-pathogenic organisms (which may be plural) can be incorporated into the delivery means to assist the growth of selected bacteria, algae, yeast, fungi, etc. In one embodiment, organisms that limit the growth of other species or specific species biofilm-forming cocktails by the release of natural antibiotics or competition for nutrients or attachment sites can be introduced to the skin around the stoma by various ostomy barriers, accessories or other application methods according to various embodiments.

[0024] In one embodiment, the ostomy skin barrier can include a lysate or population of bacteria, algae, yeast or fungi applied to the skin around the stoma in the form of an additive, gel or component. In another embodiment, the bacteria or bacterial lysate can be used directly as an ostomy powder or formulated into a spray-dried powder format that can be incorporated into wipe formulations, adhesive compositions, adhesive tape compositions, seals or paste formulations, etc. Reservoirs, gels or degradable microspheres can be utilized as delivery vehicles that vary the ostomy conditions over time.

[0025] In some embodiments, the bacterial formulation can be incorporated into an ostomy pouch film to reduce odor-causing bacteria and / or promote a skin-friendly environment. For example, the ostomy pouch can contain a population of non-pathogenic bacteria, fungi, algae, yeast, or lysates thereof. In another example, the ostomy pouch can be formed from a polymeric film containing a population of non-pathogenic bacteria, fungi, algae, yeast, or lysates thereof. Such an ostomy pouch can promote a healthy microbiome environment even if the user experiences backflow of the pouch contents. In one embodiment, the ostomy pouch can be formed from a multilayer film that includes an inner layer containing a population of non-pathogenic bacteria, fungi, algae, yeast, or lysates thereof.

[0026] In one embodiment, a lysate or population of selected bacteria, algae, yeast, or fungi can first be applied to the skin around the stoma, for example by spraying or powder application, and subsequently applied to an ostomy barrier configured to maintain desirable conditions for the applied population of bacteria, algae, yeast, or fungi.

[0027] In one embodiment, a peristomal skin treatment agent, or an ostomy appliance or accessory, can be configured to selectively promote the growth of a preferred species or mixture of preferred species, or selectively inhibit the growth of an undesirable species or mixture of undesirable species. For example, a peristomal skin treatment agent, or an ostomy appliance or accessory, can include prebiotics, postbiotics, and / or selective modulation of interface / environmental conditions to control the microbiome in the peristomal skin and in acute or chronic skin wounds and skin pathologies such as atopic dermatitis or psoriasis. A peristomal treatment agent, or an ostomy appliance or accessory, may or may not contain or deliver live bacteria or microorganisms.

[0028] In some embodiments, the stoma barrier may include a specific growth medium or otherwise change the peristomal skin environment to maintain or promote the growth of certain bacteria while inhibiting the growth of other bacteria. As used herein, the peristomal skin environment can include, but is not limited to, the ionic concentration, temperature, pH, humidity, and water content level of the peristomal skin. For example, a hydrophilic colloid stoma barrier may contain materials that promote the growth of specific species or classes of organisms while restricting the growth of other organisms by providing a selective nutrient composition, inducing high / low / anaerobic oxygen, or changing the pH of the peristomal skin. Such stoma barriers can be applied to at-risk, infected, or inoculated peristomal skin sites to establish, limit, or maintain a differential population of organisms. In one embodiment, the ostomy appliance may include a skin barrier material containing a nutrient medium configured to selectively promote the growth of a population of non-pathogenic bacteria, fungi, algae, yeast, or lysates thereof while inhibiting the growth of pathogenic organisms.

[0029] In one embodiment, the peristomal treatment agent, or stoma barrier or accessory, may be configured to regulate the relative populations of aerobic and anaerobic bacteria to improve the health of the peristomal skin. For example, the stoma barrier may be configured to deplete oxygen or provide an airtight peristomal region, creating an anaerobic environment that limits the growth of aerobic bacteria but allows or promotes the growth of anaerobic bacteria.

[0030] In one embodiment, the ostomy barrier may be configured to control the skin temperature around the stoma within a range using an integrated heating element powered by a battery, capacitor, or other power source, the temperature range being selected for the differential survival of bacteria of the genus Lactobacillus (e.g., 43°C to 46°C), which is outside the temperature range in which pathogenic Staphylococcus aureus (optimal temperature 37°C) and Staphylococcus epidermidis (optimal temperature 26°C to 37°C) or Pseudomonas aeruginosa (optimal temperature 37°C) grow successfully.

[0031] In one embodiment, the ostomy barrier can comprise a resealable opening or port for introducing a nutrient medium configured to promote the growth of selected bacteria as needed. In such an embodiment, bacterial inoculation can also be performed without changing the ostomy barrier.

[0032] In one embodiment, the ostomy barrier may comprise an inlet port, an outlet port, a humidity control reservoir, or a combination thereof configured to control humidity or gas concentration. In such an embodiment, the ostomy barrier may comprise an instrument for measuring or detecting humidity or gas levels. Adjusting the environmental humidity can enable dynamic modification of the peristomal microbiome environment. For example, by reducing the relative humidity in the peristomal area, the driving pressure for a dry skin microbiome can be upregulated, as these driving pressures may be more similar to the microenvironment of healthy sebum-free skin tissue. In one embodiment, the peristomal treatment agent can dry the peristomal skin to differentially select dehydration-tolerant species over pathogenic species that grow in a moist environment, such as waterborne bacteria (e.g., Pseudomonas aeruginosa).

[0033] In one embodiment, the ostomy barrier can include a material that contains or releases a specific carbon source while maintaining or promoting the growth of one or more bacterial species and inhibiting the growth of other bacterial species. In some embodiments, a reservoir, gel, or degradable microsphere can be used to cause or change the peristomal skin conditions over time. For example, degradable polymer microspheres containing bacteria, spores, media, and media components can have release induced based on the degradation of a carrier that can be adjusted based on the ionic conditions (hypotonic / isotonic / hypertonic) or pH level of the skin. In another example, a protein carrier may contain bacteria, spores, media, and / or media components, and the protein carrier may be configured to disintegrate in the presence of endogenous proteases, which can increase in concentration in irritated, inflamed, or infected peristomal skin, or exogenous proteases, which are present, to a lesser extent, in ileostomy and colostomy effluent. The protein carrier may be configured to disintegrate in the presence of enzymes introduced from the stoma, such as pancreatic proteases. Alternatively, degradable carbohydrate-based or lipid-based polymers can be used to deliver bacteria, spores, media, or media components in the presence of endogenous or pancreatic amylase or lipase, respectively.

[0034] In addition, probiotic organisms or prebiotic compounds can be incorporated and immobilized in a water-soluble carrier, such as polyvinyl alcohol (PVOH) or gelatin, or other functional polymer microcapsules. In one embodiment, the immobilized probiotic organism or prebiotic compound may be applied to a release liner and laminated to a stoma barrier, and the probiotic organism or prebiotic compound can be transferred to the surface of the stoma barrier facing the skin when the release liner is removed before use. When the stoma barrier is attached to the skin around the user's stoma, the immobilized probiotic organism or prebiotic compound can be placed at the interface between the stoma barrier and the user's skin, and the probiotic organism or prebiotic compound can be released by exposure to moisture, sweat or stoma effluent. In some embodiments, a mixture of prebiotic organisms and prebiotic compounds can be provided on the surface of the stoma barrier facing the skin to promote the growth of beneficial microorganisms.

[0035] The pH level of the skin around the stoma can be controlled within a range selective for the differential survival of Lactobacillus bacteria (e.g., outside the pH range in which pathogenic Staphylococcus aureus (optimal pH 7.4 - 7.6), Staphylococcus epidermidis (optimal pH 6.8) or Pseudomonas aeruginosa (optimal pH 6.6 - 7.0) grow, i.e., less than pH 5.0). In some embodiments, both the pH level and temperature of the skin around the stoma can be controlled within a selected range. In one embodiment, the skin adhesive, peristomal treatment agent, stoma barrier or accessory can include a material that is metabolized to produce metabolites that lower the pH for the selective survival of Lactobacillus species.

[0036] In one embodiment, the skin adhesive, peristomal treatment agent, ostomy barrier or accessory may be configured to provide hypertonicity (high salt content) that is differentially selective for Lactobacillus species over other bacterial species such as Pseudomonas and Staphylococcus. The hypertonic state can be created, for example, by brine treatment using NaCl, for the selective survival of Lactobacillus species over other bacterial flora.

[0037] In some embodiments, in addition to or instead of bacteria of the genus Lactobacillus, yeast or algae may be introduced to the peristomal skin. In such embodiments, the peristomal treatment agent or ostomy barrier may be configured to provide a peristomal environment that promotes the growth of yeast or algae. Yeast species suitable for peristomal skin application can include Saccharomyces cerevisiae (used in the brewing of beer), which has an optimal pH of 4 and an optimal temperature of 26°C. Suitable algae species can include those commonly used in food production such as Chlorella (optimal pH 10 - 10.5, optimal temperature 15°C, low salinity), Spirulina (optimal temperature 32°C, pH 9 - 9.5), and marine species that have evolved in seawater and can have optimal growth under hypertonic (about 0.6M) conditions.

[0038] According to various embodiments of the present disclosure, in order to limit the growth of pathogenic species, competing organisms that occupy binding sites within the exposed extracellular matrix (ECM) of the peristomal skin and compete for nutrients and other resources may be introduced. In some embodiments, haloalkaliphilic archaea can also be utilized, as these bacteria can reproduce under non - physiological conditions that are likely not harmful to the healing or maintenance of healthy peristomal skin. These species can survive not only at extreme temperatures that can be selective against typical pathogenic wound bacteria or fungi, but also in high - salt and high - pH or low - pH environments.

[0039] All patents referred to herein, whether or not explicitly recited within the text of the present disclosure, are hereby incorporated by reference in their entirety as part of this specification.

[0040] In this disclosure, the words "a" or "an" where no quantity is specified are to be construed as including both the singular and the plural. Conversely, references to plural items are, where appropriate, to be taken as including the singular.

[0041] From the foregoing description, it will be apparent that numerous changes and modifications can be made without departing from the true spirit and scope of the novel concept of this disclosure. It is to be understood that no limitation, nor any implication thereof, is intended with respect to the specific embodiments shown, and this disclosure is intended to cover all modifications within the scope of the appended claims. The invention disclosed in this specification is as follows. [1] An ostomy appliance comprising a skin barrier material and a population of non-pathogenic bacteria, fungi, algae, yeast or lysates thereof (the "population"), wherein the population is configured to limit the growth of pathogenic organisms in the skin environment around the stoma and / or selectively enhance the growth and maintenance of non-pathogenic or commensal bacteria. [2] The ostomy appliance according to [1], wherein the population is provided on the skin-facing surface of the skin barrier material or incorporated into the skin barrier material. [3] The ostomy appliance according to [1] or [2], further comprising a nutrient medium configured to selectively promote the growth of the population while inhibiting the growth of the pathogenic organisms. [4] The ostomy appliance according to any one of [1] to [3], wherein the population is provided on a release liner, the release liner is laminated to the skin barrier material, and the population is transferred to the skin-facing surface of the skin barrier material. [5] The ostomy appliance according to any one of [1] to [3], wherein the skin barrier material is formed from a skin barrier formulation incorporating the population, and the population migrates to the skin-facing surface of the skin barrier material. [6] The ostomy appliance according to any one of [1] to [5], wherein the population is selected from the group consisting of the genus Lactobacillus, Lactobacillus plantarum, lactic acid bacteria, the genus Bifidobacterium, and lysates thereof. [7] The ostomy appliance according to any one of [1] to [5], wherein the population is selected from the group consisting of Saccharomyces cerevisiae, Chlorella, Spirulina, archaea, and lysates thereof. [8] The ostomy appliance according to any one of [1] to [7], configured to deplete oxygen or provide an airtight stoma surrounding region, creating an anaerobic environment that limits the growth of aerobic bacteria while allowing the growth of anaerobic bacteria. [9] The ostomy appliance according to any one of [1] to [7], configured to provide oxygen, create an aerobic environment, limit the growth of anaerobic bacteria while allowing the growth of aerobic bacteria.

[10] The ostomy appliance according to any one of [1] to [9], configured to maintain a peristomal skin temperature of about 38°C to 48°C.

[11] The ostomy appliance according to any one of [1] to

[10] , further comprising a resealable opening or port for introducing a nutrient medium configured to promote the growth of said population while suppressing the growth of other organisms or pathogenic organisms.

[12] The ostomy appliance according to any one of [1] to

[11] , configured to control the humidity of the skin area around the stoma within a selected range in order to promote the growth of said population while suppressing the growth of said pathogenic organisms.

[13] The ostomy appliance according to any one of [1] to

[12] , configured to control the pH level of the skin area around the stoma within a selected range in order to promote the growth of said population while suppressing the growth of said pathogenic organisms.

[14] The ostomy appliance according to any one of [1] to

[13] , which is an ostomy barrier or an ostomy ring.

[15] The ostomy appliance is an ostomy pouch system, and the ostomy pouch system includes an ostomy pouch formed from a polymer film containing said population. The ostomy appliance according to any one of [1] to

[13] .

[16] A peristomal skin treatment agent, ostomy accessory or skin adhesive containing a population of non-pathogenic bacteria, fungi, algae, yeast or lysates thereof ("population"), said population being configured to limit the growth of pathogenic organisms in the skin in the peristomal skin environment and / or selectively enhance the growth and maintenance of non-pathogenic or commensal bacteria. A peristomal skin treatment agent, ostomy accessory or skin adhesive.

[17] The peristomal skin treatment agent according to

[16] , which is a skin protectant, skin conditioner or lotion, an ostomy accessory or a skin adhesive.

[18] The peristomal skin treatment agent, ostomy accessory or skin adhesive according to

[16] or

[17] , wherein said population is contained in degradable polymer microspheres configured to degrade when exposed to ionic conditions or the pH level of the peristomal skin.

[19] The peristomal skin treatment agent, ostomy accessory or skin adhesive according to

[16] or

[17] , wherein said population is contained in a protein carrier configured to disintegrate in the presence of endogenous or introduced proteases.

[20] The composition according to

[16] or

[17] , wherein the population is contained in a lipid carrier, and the lipid carrier is configured to decompose in the presence of endogenous lipase or introduced lipase, such as pancreatic lipase, is a peristomal skin treatment agent, an ostomy accessory, or a skin adhesive.

[21] The composition according to

[16] or

[17] , wherein the population is contained in a carbohydrate carrier, and the carbohydrate carrier is configured to disintegrate in the presence of endogenous amylase or introduced amylase, is a peristomal skin treatment agent, an ostomy accessory, or a skin adhesive.

[22] The composition according to

[16] or

[17] , wherein the population is incorporated and immobilized in a water-soluble carrier, and the water-soluble carrier is formed from polyvinyl alcohol, gelatin, or a functional polymer, is a peristomal skin treatment agent, an ostomy accessory, or a skin adhesive.

[23] The peristomal skin treatment agent, ostomy accessory, or skin adhesive according to any one of

[16] to

[22] , wherein the peristomal skin treatment agent is provided in the form of a powder or a paste.

[24] The peristomal skin treatment agent, ostomy accessory, or skin adhesive according to any one of

[16] to

[23] , further comprising a protease inhibitor.

[25] A method for improving or maintaining the health of peristomal skin, comprising the steps of applying a population of non-pathogenic bacteria, fungi, algae, yeast, or lysates thereof (the "population") to the peristomal skin, and attaching an ostomy barrier, skin adhesive, skin treatment agent, or appliance configured to promote the growth of the population.

[26] The method according to

[25] , wherein the population is provided in the form of a liquid, gel, paste, or powder and is applied to the peristomal skin.

[27] The method according to

[25] or

[26] , wherein the ostomy barrier or skin adhesive comprises a nutritional probiotic medium configured to promote the growth of the population or existing non-pathogenic bacteria, fungi, algae, or yeast while inhibiting the growth of other organisms or pathogenic organisms.

[28] The method according to any one of

[25] to

[27] , wherein the ostomy barrier or skin adhesive changes at least one of the temperature, moisture content, humidity, and pH level of the peristomal skin, and is configured to promote the growth of the population or existing non-pathogenic bacteria, fungi, algae, or yeast while inhibiting the growth of other organisms or pathogenic organisms. The method according to any one of

[25] to

[28] , wherein the ostomy barrier or skin adhesive is configured to change the humidity at the skin interface by including a desiccant, a salt, and / or a volatile solvent in the formulation.

Claims

**Claim 1** An ostomy appliance comprising a skin barrier material and a population of non - pathogenic bacteria, fungi, algae, yeast or lysates thereof (the "population"), wherein the population is configured to limit the growth of pathogenic organisms and / or selectively enhance the growth and maintenance of non - pathogenic or commensal bacteria in the peristomal skin environment. **Claim 2** The ostomy appliance according to claim 1, wherein the population is provided on the skin - facing surface of the skin barrier material or incorporated into the skin barrier material. **Claim 3** The ostomy appliance according to claim 1, further comprising a nutrient medium configured to selectively promote the growth of the population while inhibiting the growth of the pathogenic organisms. **Claim 4** The ostomy appliance according to claim 1, wherein the population is provided on a release liner, the release liner is laminated to the skin barrier material, and the population is transferred to the skin - facing surface of the skin barrier material. **Claim 5** The ostomy appliance according to claim 1, wherein the skin barrier material is formed from a skin barrier formulation incorporating the population, and the population migrates to the skin - facing surface of the skin barrier material. **Claim 6** The ostomy appliance according to claim 1, wherein the population is selected from the group consisting of Lactobacillus, Lactobacillus plantarum, lactic acid bacteria, Bifidobacterium, and lysates thereof. **Claim 7** The ostomy appliance according to claim 1, wherein the population is selected from the group consisting of Saccharomyces cerevisiae, Chlorella, Spirulina, archaea, and lysates thereof. **Claim 8** The ostomy appliance according to claim 1, configured to deplete oxygen or provide an airtight peristomal region, creating an anaerobic environment that limits the growth of aerobic bacteria while allowing the growth of anaerobic bacteria. **Claim 9** The ostomy appliance according to claim 1, configured to provide oxygen, creating an aerobic environment that limits the growth of anaerobic bacteria while allowing the growth of aerobic bacteria. **Claim 10** The ostomy appliance according to claim 1, configured to maintain a peristomal skin temperature of about 38°C to 48°C. **Claim 11** The ostomy appliance according to claim 1, further comprising a resealable opening or port for introducing a nutrient medium configured to promote the growth of the population while inhibiting the growth of other organisms or pathogenic organisms. **Claim 12** The ostomy appliance according to claim 1, configured to control the humidity of the skin area around the stoma within a selected range while promoting the growth of said population and suppressing the growth of said pathogenic organisms.

13. The ostomy appliance according to claim 1, configured to control the pH level of the skin area around the stoma within a selected range while promoting the growth of said population and suppressing the growth of said pathogenic organisms.

14. The ostomy appliance according to claim 1, which is an ostomy barrier or an ostomy ring.

15. The ostomy appliance according to claim 1, wherein the ostomy appliance is an ostomy pouch system, and the ostomy pouch system includes an ostomy pouch formed from a polymer film containing said population.