Pharmaceutical composition for preventing or treating alopecia comprising faecalibacterium

Faecalibacterium strains in pharmaceutical, food, and cosmetic compositions address the limitations of existing alopecia treatments by promoting hair growth and preventing scalp aging without side effects, providing a safer and more effective solution for alopecia.

WO2026155284A1PCT designated stage Publication Date: 2026-07-23ENTEROBIOME INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
ENTEROBIOME INC
Filing Date
2025-02-18
Publication Date
2026-07-23

AI Technical Summary

Technical Problem

Existing alopecia treatments, such as minoxidil and finasteride, have significant side effects and are not effective in preventing or treating alopecia without causing recurrence when discontinued, while compositions using Lactobacillus fermentum and Enterococcus lactic acid bacteria have not shown substantial alopecia treatment effects.

Method used

A pharmaceutical, food, and cosmetic composition comprising Faecalibacterium strains, including Faecalibacterium prausnitzii EB-FPDK9, which promotes hair papilla cell proliferation, increases hair growth factors, and suppresses oxidative stress, thereby promoting hair follicle formation and growth without side effects.

Benefits of technology

The Faecalibacterium-based compositions effectively promote hair growth, delay the hair cycle anagen phase, and prevent scalp aging, offering a safer and more effective alternative to existing treatments with reduced side effects.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a pharmaceutical composition, a food composition and a cosmetic composition for preventing or treating alopecia, which comprises at least one strain of genus Faecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one pharmaceutically acceptable carrier or excipient. According to the present invention, a composition having excellent alopecia prevention and hair growth promotion effects while being safe for the human body and having no side effects can be provided.
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Description

PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING ALOPECIA COMPRISING FAECALIBACTERIUM

[0001] The present invention relates to a composition for preventing or treating or improving alopecia, and more particularly, to a pharmaceutical composition, food composition and cosmetic composition for preventing or treating or improving alopecia comprising at least one strain of genusFaecalibacterium.

[0002] Recently, the number of patients with alopecia is rapidly increasing, and the age of patients suffering from alopecia is gradually decreasing. As alopecia becomes more severe, patients may complain of psychological symptoms of depression or anxiety, and may experience difficulties in adapting to interpersonal relationships, so alopecia is becoming a major public health concern.

[0003] Male pattern alopecia is a phenomenon caused by the male hormone testosterone, and the method of inhibiting the production of dihydrotestosterone (DHT) is mainly used to treat male pattern alopecia. On the other hand, female pattern alopecia is mainly caused by a decrease in the amount of estrogen after menopause. Minoxidil or estrogen is mainly used as a treatment for female pattern alopecia.

[0004] Drugs that can be used to treat alopecia include androgen inhibitors such as minoxidil and finasteride; female hormones such as estrogen, estradiol, and progesterone; and antifungal agents such as ketoconazole, pentadecane, cytopurine (6-benzyl amino purine), t-flavanone, and adenosine.

[0005] However, minoxidil has side effects such as drug-induced contact alopecia, unwanted hair growth, decreased blood pressure, and decreased heart rate, and there is a problem that symptoms recur immediately when use is discontinued. On the other hand, finasteride has side effects such as sexual dysfunction, and symptoms worsen when use is discontinued. In addition, minoxidil can cause hirsutism or birth defects when women use it in high doses, and finasteride has a risk of birth defects, so it is currently contraindicated for administration to women, especially pregnant women.

[0006] Meanwhile, in an effort to obtain an alopecia prevention effect using microorganisms, Korean Patent No. 1791088 discloses a food composition for alopecia prevention comprising a culture ofLactobacillus fermentum. Korean Patent Publication No. 2022-0021144 discloses a pharmaceutical composition for alopecia treatment comprising lactic acid bacteria of genusEnterococcus.However, noneof these compositions has shown a significant alopecia treatment effect yet.

[0007] The present invention is intended to solve the above problems, and one object of the present invention is to provide a composition for preventing or treating alopecia that is safe for the human body and has no side effects, while having excellent alopecia prevention, hair thickening or hair growth promotion effects.

[0008] Another object of the present invention is to provide a food for preventing or improving alopecia comprising at least one strain of genusFaecalibacterium.

[0009] Still another object of the present invention is to provide a cosmetic composition that can prevent, alleviate and improve alopecia and promote hair growth by preventing, alleviating and preventing scalp aging.

[0010] One aspect of the present invention providesacomposition for preventing or treating alopecia, comprising at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one pharmaceutically acceptable carrier or excipient.

[0011] The above strains of genusFaecalibacteriummay be aFaecalibacterium prausnitziistrain,Faecalibacteriumspp., or a combination thereof. TheFaecalibacterium prausnitziistrain may be, for example, aFaecalibacterium prausnitziiEB-FPDK9 (KCCM12620P) strain. The strain of genusFaecalibacteriummay be a viable cell, a non-viable cell, or a combination thereof.

[0012] In the present invention, alopecia may be alopecia caused by alopecia areata, androgenetic alopecia, female pattern alopecia, middle-aged alopecia, senile alopecia, seborrheic alopecia, alopecia premature, postpartum alopecia, hypotrichosis, or chemotherapy induced alopecia.

[0013] The pharmaceutical composition for preventing or treating alopecia of the present invention may further comprise at least one alopecia treatment agent selected from the group consisting of finasteride, dutasteride, minoxidil, episteride, alfatradiol, tofacitinib, and ruxolitinib, in addition to the strain of genusFaecalibacterium.

[0014] The pharmaceutical composition for preventing or treating alopecia of the present invention may further comprise other probiotic strains or one or more prebiotics.

[0015] Another aspect of the present invention relates to a food comprising at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one physiologically acceptable carrier or excipient.

[0016] Still another aspect of the present invention relates to a cosmetic composition comprising at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one physiologically acceptable carrier or excipient.

[0017] Still another aspect of the present invention relates to a method for preventing hair loss, promoting hair regrowth and hair growth by using at least one strain of genusFaecalibacterium.

[0018] According to various embodiments of the present invention, it was confirmed that the strain of genusFaecalibacteriumpromotes the proliferation of hair papilla cells, which are key cells in hair follicle formation and hair growth, increases the levels of hair growth promoting factors, and suppresses oxidative stress that causes alopecia. Therefore, the composition according to the present invention can effectively promote hair follicle formation and hair growth, and thus can be advantageously utilized as a preparation for preventing, improving, and / or treating alopecia.

[0019] The food of the present invention not only generates new hair or promotes hair growth, but also promotes the delay from the anagen phase to the catagen phase of the hair cycle and allows existing hair to grow healthily.

[0020] The cosmetic composition of the present invention comprising the strain of the genusFaecalibacteriumis capable of preventing, alleviating and inhibiting scalp aging, improving the alopecia prevention effect caused thereby, and providing a hair growth or hair regrowth promoting effect.

[0021] The composition of the present invention is expected to be safer for clinical application while exhibiting an effect equivalent to that of the existing alopecia treatment agent, such as minoxidil. In addition, the composition of the present invention can exhibit excellent hair growth and alopecia prevention effects on sparse hair or alopecia (hair loss) in women with reduced female hormone levels.

[0022] Fig. 1 shows the results of examining the effects of strains of genusFaecalibacteriumon cell proliferation and viability of hair papilla cells.

[0023] Fig. 2 shows the results of confirming the expression pattern of hair growth factors in hair papilla cells by the strain of genusFaecalibacteriumof the present invention using RT-qPCR.

[0024] Fig. 3 shows the results of a Western blot analysis of the expression patterns of factors that promote the proliferation of hair papilla cells by the strain of genusFaecalibacteriumof the present invention.

[0025] Fig. 4 shows the results of measuring the antioxidant enzyme gene expression regulation ability of hair papilla cells treated with aFaecalibacteriumstrain using RT-qPCR to confirm the oxidative stress inhibition effect of the strain of genusFaecalibacteriumof the present invention.

[0026] Fig. 5 shows an animal test design for evaluating the anagen phase induction effect by the strain of genusFaecalibacteriumof the present invention.

[0027] Fig. 6 is a photograph showing the results of treating a mouse model with a strain of genusFaecalibacteriumto confirm the effect of inducing anagen phase by strain of genusFaecalibacteriumand comparing the extent of hair growth by group.

[0028] Fig. 7 is a graph comparing the hair length after the end of the experiment to evaluate the efficacy of promoting hair length growth in mice.

[0029] Figs. 8a-c show the results of histological analysis of the extent of hair follicle formation in the anagen phase of a mouse model byFaecalibacteriumstrains using hematoxylin and eosin staining. Fig. 8a shows the results of observing the number and diameter of hair follicles in skin tissue using H&E staining, Fig. 8b shows the results of observing the relative ratio of telogen and anagen hair follicles in skin tissue using H&E staining, and Fig. 8c shows the results of confirming Ki67 positive cells, a cell proliferation and anagen phase maintenance marker, in skin tissue using immunofluorescence staining.

[0030] Fig. 9 shows the results of measuring the expression pattern of hair growth stimulating factors in skin tissue by the strain of genusFaecalibacteriumof the present invention using RT-qPCR.

[0031] Fig. 10 shows an animal test design for testing the effect of improving hair condition by a strain of genusFaecalibacteriumin aged mice.

[0032] Fig. 11 is a photograph showing the results of a comparison of the effects of a strain of genusFaecalibacteriumon the improvement of age-related alopecia.

[0033] Hereinafter, the present invention will be described in more detail. In describing the present invention, if it is judged that a detailed description of a configuration or function of a related known technology may obscure the gist of the present invention, the detailed description will be omitted.

[0034] Throughout this specification and claims, unless otherwise stated, the terms "comprise" or "comprising" are intended to mean inclusion of the element or component mentioned, but not to the exclusion of any other element or component.

[0035] As used herein, the term "hair loss" or "alopecia" means deficiency of hair growth and partial or complete loss of hair, and includes, but is not limited to, androgenic alopecia or male pattern alopecia, toxic alopecia, alopecia areata, telogen effluvium, alopecia due to endocrine abnormality, a metabolic disorder or malnutrition, drug-induced alopecia, mechanical alopecia, alopecia accompanied by skin disorders, cicatricial alopecia, congenital alopecia and trichotillomania.

[0036] The term "prevention of hair loss" as used herein means prevention, inhibition, retardation and reduction of partial or complete hair loss.

[0037] The term "promotion of hair regrowth" as used herein is defined to include maintenance, induction, stimulation, promotion and restoration of hair generation, growth of deficient hair, or extension of anagen in hair growth cycle.

[0038] The term "hair growth" as used herein is defined to include prevention of loss and promotion of development and growth of vellus hair, and conversion of vellus hair into terminal hair.

[0039] As used herein, the term "subject" means an animal, including but not limited to a primate (e.g., a human), a cow, a pig, a sheep, a goat, a horse, a dog, a cat, a rabbit, a rat or a mouse.

[0040] As used herein, the terms "treat", "treatment", and the like mean to temporarily or permanently alleviate symptoms, eliminate the cause of symptoms, or prevent or delay the onset of symptoms of a disease or condition.

[0041] The term "prevention" as used herein means any act of inhibiting or delaying the onset of alopecia by administering a pharmaceutical composition according to the present invention.

[0042] As used herein, the term "improvement" means any action that reduces a parameter associated with an abnormal condition, for example, the severity of a symptom.

[0043] The term "pharmaceutically acceptable" as used herein means a composition that is suitable for use in contact with the tissues of a subject (e.g., a human) without excessive toxicity, irritation, allergic response or other problems and with a reasonable benefit / risk ratio, and is within the scope of sound medical judgment.

[0044] As used herein, the term "culture" may refer to a composition after culturing is completed, and more specifically, the culture may or may not include bacterial cells. Accordingly, the culture may include a culture supernatant, a composition from which the culture supernatant has been removed, or a composition obtained by concentrating these. The composition of the culture may further comprise a component that acts synergistically on the growth of genusFaecalibacteriumin addition to the components required for typicalFaecalibacteriumprausnitziiculture, and the composition accordingly may be easily selected by a person skilled in the art.

[0045] One exemplary aspect of the present invention relates to a composition for preventing or treating alopecia, comprising at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one pharmaceutically acceptable carrier or excipient.

[0046] The term "Faecalibacterium" as used herein refers to at least one bacterium belonging to the genusFaecalibacterium, which itself belongs to the phylumFirmicutes.The genus includes, but is not necessarily limited to,Faecalibacteriumprausnitzii,Faecalibacteriumhattorii, Faecalibacteriumduncaniae,andFaecalibacteriumgallinarum.The term also includes variants of species or strains belonging to the genusFaecalibacterium.

[0047] Any strain of genusFaecalibacteriumcan be used if it is commonly known. For example, it can be aFaecalibacteriumprausnitziistrain,Faecalibacterium spp., or a combination thereof. A non-limiting example of the strain of genusFaecalibacteriumin the present invention is theFaecalibacteriumprausnitziiEB-FPDK9 strain isolated and deposited by the applicant. Specifically, it is preferable to usethe Faecalibacterium prausnitziiEB-FPDK9 strain, which the applicant deposited with the Korean Culture Center of Microorganisms (KCCM) on November 1, 2019 under the Budapest Treaty and was assigned the accession number KCCM12620P.

[0048] The strain of genusFaecalibacteriummay be in the form of viable cells, non-viable cells, or a combination of viable and non-viable cells. For the purposes of the present invention, the term "non-viable cells" means cells that are metabolically and / or reproductively incapable of surviving. Viable cells include dormant cells, and non-viable cells include dead bacteria, inactivated bacteria, or pasteurized bacteria.

[0049] The term "dead cells" as used herein means a strain that has been inactivated by heat treatment. In one embodiment, the heat-inactivated cells of genusFaecalibacteriumof the present invention are preferably prepared by heat treating at least one strain of genusFaecalibacteriumat a temperature of 50℃ to 100℃, preferably at a temperature of 60℃ to 95℃, more preferably at a temperature of 70℃ to 90℃ for 5 minutes to 1 hour, but are not limited thereto. When the heat treatment temperature is increased, the heat treatment time can be shortened.

[0050] In addition, in the present invention, the state of the strain of genusFaecalibacteriummay be a liquid state or a dry state, and the drying method may include ventilation drying, natural drying, spray drying, and freeze drying, but is not necessarily limited to these methods.

[0051] In the context of the present invention, lyophilized cells or bacteria are understood as meaning, in particular, bacteria which, by sublimation by lyophilization, also referred to as freeze-drying, are gently dried and stored or preserved in this manner.

[0052] The composition of the present invention may further comprise one or more cryoprotectants to maintain the viability of bacterial cells in the composition when lyophilized during transport or storage. Non-limiting examples of such cryoprotectants can be glycerol, dimethyl sulfoxide (DMSO), ethylene glycol, propylene glycol, 2-methyl-2,4-pentanediol, trehalose, sucrose, diethyl glycol, triethylene glycol, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), saccharose, formamide, glycerol 3-phosphate, proline, methyl alcohol, glucose, bovine serum albumin, polyvinyl alcohol, hydroxyethyl starch, sorbitol, or combinations thereof. The cryoprotectant may also comprise an antioxidant. Such antioxidants can be used to provide anaerobic conditions during storage or transport and to protect bacterial cells from reactive oxygen species. Examples of antioxidants include, but are not limited to, ascorbic acid, dithiothreitol, glutathione, phenolic acids, phenolic diterpenes, flavonoids, volatile oils, alpha-tocopherol, trolox, vitamin A, vitamin C, and coenzyme Q10.

[0053] In one aspect of the present invention, the live bacteria are administered directly to the gastrointestinal tract by intrarectal delivery. Other options for non-bacterial delivery include gut-dependent routes, including systemic delivery, such as by intraperitoneal injection. In a preferred embodiment of the present invention, the compositions of the present invention may be administered orally, subcutaneously or topically.

[0054] The pharmaceutical composition for preventing or treating alopecia of the present invention may comprise the strain of genusFaecalibacteriumin an amount ranging from about 1Х102to about 1Х1015CFU, preferably from about 1Х104to about 1Х1012CFU, more preferably from about 1Х105to about 1Х1010CFU, and even more preferably from about 1Х106to about 1Х109CFU. If the dosage of the strain is less than the above range, there is a problemin that it is difficult to exhibit sufficient alopecia prevention and hair growth promotion effects, and if the dosage of the strain exceeds the above range, it is difficult to expect an additional increase in effect.

[0055] In the present invention, strains of genusFaecalibacteriumis substantially purified. The substantially purifiedFaecalibacteriumstrain can be present in the sample at least about 50%, preferably at least about 60%, 70%, 80%, 90%, 95%, 99% or more.

[0056] The composition of the present invention can be used for treating alopecia caused by alopecia areata, androgenetic alopecia, female pattern alopecia, middle-aged alopecia, senile alopecia, seborrheic alopecia, alopecia premature, postpartum alopecia, hypotrichosis, or chemotherapy induced alopecia.

[0057] The composition of the present invention may further comprise at least one alopecia treatment agent selected from the group consisting of finasteride and dutasterid, minoxidil, episteride, tofacitinib, and ruxolitinib.

[0058] Strain(s) of genusFaecalibacteriummay be administered simultaneously with the alopecia treatment agent as a single formulation, or simultaneously or sequentially as separate formulations. The pharmaceutical composition for preventing or treating alopecia of the present invention not only exhibits an excellent alopecia prevention effect when administered alone, but also, when administered in combination with alopecia treatment agents such as minoxidil and finasteride, the side effects of the alopecia treatment agents are reduced and the efficacy is further activated, thereby exhibiting an even better therapeutic effect compared to when they are administered alone.

[0059] In one embodiment of the present invention, the culture of the strain of genusFaecalibacteriumrefers to a culture product including some or all of the substances contained in the medium in which the strain is cultured, including a culture medium or a culture solution, and a concentrate thereof. For example, it may refer to a metabolic product or secretion resulting from strain culture, or a lysate thereof, and the strain itself may also be included in the culture.

[0060] According to the present invention the term "lysate" means a solution or suspension in an aqueous medium of cells of the microorganism of the present invention that are broken. However, the term should not be construed in any limiting way. The cell lysate comprises, e.g., macromolecules, like DNA, RNA, proteins, peptides, carbohydrates, lipids and the like and / or micromolecules, like amino acids, sugars, lipid acids and the like, or fractions of it. Additionally, said lysate comprises cell debris which may be of smooth or granular structure. Methods for preparing cell lysates of microorganism are known in the art, for example, by employing French press, cells mill using glass or iron beads or enzymatic cell lysis and the like. In addition, lysing cells relates to various methods known in the art for opening / destroying cells.

[0061] As used herein, the term "extract" means a subcellular component of the microorganism of the present invention, e.g., macromolecules, like DNA, RNA, proteins, peptides, carbohydrates, lipids and the like and / or micromolecules, like amino acids, sugars, lipid acids and the like or any other organic compound or molecule, or fractions of it. Specifically, the extract may be an ethanol fraction or an ethanol precipitate.

[0062] The pharmaceutical composition of the present invention may comprise at least one pharmaceutically acceptable carrier or vehicle.

[0063] The pharmaceutically acceptable carriers include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methyl hydroxybenzoate, propyl hydroxy benzoate, talc, magnesium stearate, mineral oil, and the like. In addition, diluents or excipients such as fillers, bulking agents, binders, wetting agents, disintegrating agents, and surfactants are included.

[0064] The above pharmaceutical composition is prepared in the form of oral preparations such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, parenteral preparations, injection preparations, and the like according to conventional methods.

[0065] It can be formulated in the form of a topical administration preparation.

[0066] Among oral preparations, oral solid preparations include tablets, pills, powders, granules, capsules, etc., and these solid preparations may include at least one excipient, for example, starch, calcium carbonate, sucrose or lactose, gelatin, etc., and may include lubricants, such as magnesium stearate and talc. Among oral preparations, oral liquid preparations include suspensions, solutions, emulsions, syrups, etc., and may include diluents, such as water and liquid paraffin, wetting agents, sweeteners, fragrances, preservatives, etc. Parenteral preparations include sterilized aqueous solutions, non-aqueous solvents, suspensions, emulsions, and lyophilized preparations, and non-aqueous solvents and suspending agents include propylene glycol, polyethylene glycol, oligosaccharides, etc. and vegetable oils such as olive oil, injectable esters such as ethyl oleate, etc.

[0067] The composition of the present invention may be administered to a mammal, including or not including a human, by various routes, for example, orally, intravenously, intramuscularly, or by subcutaneous injection.

[0068] The composition of the present invention may be administered topically. Topical administration means direct application of the active ingredient or composition (such as a composition for external use in the skin) to the skin and / or hair. The topical composition of the present invention may be in the form of a solution, lotion, paste, cream, ointment, liposome, spray, gel, foam, roller stick, or any other formulation routinely used in dermatology.

[0069] In the pharmaceutical composition of the present invention, the dosage of the active ingredient varies depending on the patient's condition and weight, the degree of the disease, the drug form, the route of administration, the period, etc., but may be appropriately selected depending on the case. The preferred dosage of the pharmaceutical composition of the present invention may be in the range of 0.001 mg / kg to 10 g / kg per day, preferably in the range of 0.001 mg / kg to 1 g / kg, depending on the patient's condition, weight, sex, age, the patient's severity, and the route of administration. The administration may be administered once a day or divided into several times. Such dosage should not be construed as limiting the scope of the present invention in any way.

[0070] In one embodiment of the present invention, the composition of the present invention may further comprise other probiotic strains or one or more prebiotics in addition to the strain of genusFaecalibacterium.

[0071] Other probiotic strains may include probiotics from the phylaBacteroidetes,Firmicutes,Actinobacteria, orProteobacteria. In one embodiment, the other probiotics may be one or more strains of genusFirmicutessp.,Ruminococcussp.,Clostridiumsp.,Akkermansiasp.,Bacteroidessp.,Lactobacillussp., orBifidobacteriumsp. In addition, it may be one or more strains of the generaNeglectasp., Egerthellasp.,Clostridiaceaesp.,Parabacteroidessp.,Bilophilasp.,Doreasp., andCollinsellasp.

[0072] The term "prebiotic" as used herein means a substance that, although not digestible by humans, imparts a beneficial physiological effect to the host by modulating the composition and / or activity of the microbiota, e.g., the gut microbiota, through metabolism by intestinal microorganisms.

[0073] Examples of prebiotics that may be used in the present invention include, but are not limited to, inulin and inulin-like fructans, oligofructose, beta-glucans, xylose, arabinose, arabino xylan, ribose, galactose, rhamnose, cellobiose, fructose, lactose, salicin, sucrose, glucose, esculin, trehalose, maltose, mannose, melibiose, mucus or mucin, raffinose, fructooligosaccharides, galacto-oligosaccharides, amino acids, alcohols, fermentable carbohydrates, and any combination thereof.

[0074] Another aspect of the present invention relates to a method for treating alopecia in a subject in need thereof, the method comprising administering to the subject at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture, or an extract of the lysate.

[0075] In still another aspect, the present invention relates to a method of treating a hair-loss disorder in a subject in need thereof comprising orally administering to the human an effective amount of at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture, or an extract of the lysate in a pharmaceutical composition selected from a capsule, a tablet, a pill, and a troch.

[0076] In still another aspect, the present invention relates to a food for preventing or suppressing alopecia and promoting hair growth. The food composition of the present invention comprises at least one strain of genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one physiologically acceptable carrier or excipient.

[0077] In the present invention, any strain of genusFaecalibacteriumcan be used, but for example, it can be aFaecalibacterium prausnitziistrain, Faecalibacterium spp., or a combination thereof. A specific example of theFaecalibacteriumprausnitziistrain is theFaecalibacteriumprausnitziiEB-FPDK9 strain isolated and deposited by the present applicant.

[0078] Above strains of genusFaecalibacteriummay be viable, nonviable, or a combination thereof.

[0079] The food of the present invention can be manufactured as a health functional food such as a functional beverage, a health supplement, a special nutritional supplement food. The food may be in the form of beverages such as tea, juice, carbonated beverages, and ionic beverages, processed dairy products such as milk and yogurt, foods such as gum, rice cakes, bread, confectionery, and noodles, or health functional food preparations such as powders, tablets, and capsules.

[0080] The food of the present invention may comprise, in addition to the effective ingredient, a sweetener, a flavoring agent, a physiologically active ingredient, minerals, etc.

[0081] Sweeteners may be used in amounts that provide a moderate sweetness to foods and may be natural or synthetic. Natural sweeteners include sugar sweeteners such as corn syrup solids, honey, sucrose, fructose, lactose, and maltose.

[0082] Flavoring agents can be used to improve taste or aroma, and both natural and synthetic ones can be used. It is preferable to use natural ones. When using natural ones, in addition to flavor, the purpose of enhancing nutrition can also be used. Natural flavoring agents can be obtained from apples, lemons, tangerines, grapes, strawberries, peaches, etc., or from green tea leaves, dandelions, bamboo leaves, cinnamon, chrysanthemum leaves, jasmine, etc. In addition, those obtained from ginseng (red ginseng), bamboo shoots, aloe vera, ginkgo nuts, etc. can be used. Synthetic flavoring agents can be used from esters, alcohols, aldehydes, terpenes, etc.

[0083] As physiologically active substances, catechins such as catechin, epicatechin, gallogatechin, and epigallocatechin, and vitamins such as retinol, ascorbic acid, tocopherol, calciferol, thiamine, and riboflavin can be used.

[0084] As minerals, calcium, magnesium, chromium, cobalt, copper, fluoride, germanium, iodine, iron, lithium, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, silicon, sodium, sulfur, vanadium, and zinc can be used.

[0085] In addition, the food of the present invention may comprise a preservative, an emulsifier, an acidulant, a thickener, etc., as needed. These preservatives, emulsifiers, etc. are known in the art, and any of those known in the art may be used.

[0086] The food of the present invention can obtain a more excellent alopecia prevention or improvement effect by consuming it in the form of inner beauty food. As used herein, the term "inner beauty food" refers to food which is also referred to as "edible cosmetics" or "beauty food" and food that improves skin health by helping various ingredients beneficial to the skin to be absorbed into the body.

[0087] Another aspect of the present invention may be a cosmetic composition, wherein the cosmetic composition may comprise the strain of genusFaecalibacterium, preferably aFaecalibacteriumprausnitziistrain, Faecalibacteriumspp. or a combination thereof. The cosmetic composition of the present invention comprisesFaecalibacterium prausnitziiEB-FPDK9 strain (KCCM12620P), a culture of the strain, endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one physiologically acceptable carrier or excipient. The strain of genusFaecalibacteriummay be a viable strain, a non-viable strain, or a combination thereof.

[0088] The cosmetic composition of the present invention may be manufactured in various forms according to a conventional cosmetic manufacturing method. Specifically, the cosmetic composition may be manufactured in the form of a hair tonic, a hair cream, a hair lotion, a hair shampoo, a hair rinse, a hair conditioner, a hair spray, a hair aerosol, a pomade, a powder, a gel, a hair pack, a hair treatment, an eyebrow hair tonic, an eyelash hair tonic, an eyelash nutrient, or an ointment.

[0089] In addition, the cosmetic composition may comprise conventional excipients such as stabilizers, solubilizers, vitamins, pigments and fragrances commonly used in the field of cosmetic compositions, and may comprise a carrier acceptable for cosmetic use.

[0090] Acceptable carriers for cosmetic use include, but are not limited to, purified water, oils, waxes, fatty acids, fatty alcohols, fatty acid esters, surfactants, absorbents, thickeners, viscosity stabilizers, chelating agents, buffers, preservatives, and lower alcohols. Humectants, anti-inflammatory agents, antibacterial agents, antifungal agents, vitamins, sunscreens, antibiotics, perfumes, and dyes may also be included as needed.

[0091] The cosmetic composition according to the present invention can prevent, alleviate and prevent scalp aging, thereby alleviating and improving alopecia that may be accelerated thereby.

[0092] Hereinafter, the present invention will be described in detail by way of examples. However, the following examples are merely examples to help with the overall understanding of the present invention, and the content of the present invention is not limited to the following examples.

[0093]

[0094] Example

[0095] Example 1: Analysis of cell proliferation effect by genusFaecalibacteriumin hair papilla cells

[0096] 1.1 Strain sample

[0097] TheFaecalibacteriumprausnitziiEB-FPDK9 strain used in this example was prepared at a concentration of 1X109bacteria / ㎖ PBS as live and dead cells for use in cell experiments. The dead cells were obtained by heat-treating the culturedFaecalibacterium prausnitziiEB-FPDK9 strain at 70℃ for 30 minutes and centrifuging at 12,000xg and 4℃ for 10 minutes to obtain a pellet. The pellet was resuspended in sterilized PBS and stored at -80℃ until immediately before use in the experiment.

[0098]

[0099] 1.2 Culturing hair papilla cells

[0100] Human hair follicle dermal papilla cells (CEFOTM) were passaged at a density of 5,000 to 7,000 cells / cm2in a 37℃ incubator (hereinafter referred to as CO2incubator) supplied with 5% CO2and 95% air using a culture medium (Human hair follicle dermal papilla cell growth Medium, #CEFOgro-HDP) comprising supplementsand antibiotics (penicillin and streptomycin), and maintained no longer than passage 8.

[0101]

[0102] 1.3 Evaluation of hair papilla cell proliferation efficacy

[0103] Dermal papilla cells play a key role in regulating hair growth and cycles within hair follicles. Dermal papilla cells interact with hair follicle stem cells and secrete various signaling molecules that stimulate or inhibit hair growth, regulate hair thickness and growth rate, and activate the regenerative capacity of hair follicles.

[0104] To measure and compare the cell proliferation capacity of papilla cells, papilla cells were seeded at 2X104cells / 100 ㎕ in a 96-well plate andtreated with genusFaecalibacterium prausnitziiEB-FPDK9 strain at a concentration of 1X106-1X108bacteria / ㎖.GenusFaecalibacteriumprausnitziiEB-FPDK9 strain (EB-FPDK9) and heat-inactivatedFaecalibacteriumprausnitziiEB-FPDK9 strain (FPDK9-HK) were treated, respectively. After 72 hours of treatment with the test strains, cell culture supernatant and cells were obtained, and LDH assay (Cytotoxicity LDH Assay Kit-WST, #CK12, Dojindo) and MTT assay (Thiazolyl Blue Tetrazolium Bromide, #M5655, Sigma) were performed. The results of LDH analysis and MTT analysis measured in hair papilla cells treated with liveFaecalibacteriumprausnitziiEB-FPDK9 strain(EB-FPDK9) and heat-inactivatedFaecalibacteriumprausnitziiEB-FPDK9 strain(FPDK9-HK) are shown in Fig. 1.

[0105] Referring to Fig. 1, the LDH analysis results showed that the liveFaecalibacteriumprausnitziiEB-FPDK9 strain (EB-FPDK9) significantly increased the proliferation of hair papilla cells, and the MTT analysis results showed that heat-inactivatedFaecalibacteriumprausnitziiEB-FPDK9 stain(FPDK9-HK) significantly increased the proliferation of hair papilla cells.

[0106]

[0107] 1.4 Measurement of hair papilla cell growth factor expression

[0108] To compare the level of growth factor expression in hair papilla cells, hair papilla cells were seeded at 1X105cells / 500㎕ in a 24-well plate and treated withliveFaecalibacterium prausnitziiEB-FPDK9strain (EB-FPDK9) and heat-inactivatedFaecalibacteriumprausnitziiEB-FPDK9 stain (FPDK9-HK) at a concentration of 1X107bacteria / ㎖. 24 hours after strain treatment, mRNA was extracted using Trizol (#15596026, Invitrogen). The extracted mRNA was quantified and cDNA was synthesized using an M-MLV cDNA Synthesis Kit (#EZ006M, Enzynomics) according to the manual. The reaction was performed with a KAPA SYBR FAST qPCR kit (#KK4605, Roche), cDNA, and the primers in Table 1 below in QuantStudio 5 (Applied Biosystems). The results of measuring the expression of cell growth factors (VEGF, HGF, FGF-22) in hair papilla cells treated with liveFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) and heat-inactivatedFaecalibacterium prausnitziiEB-FPDK9 stain (FPDK9-HK) are shown in Fig. 2.

[0109] Referring to Fig. 2, the expression of vascular endothelial growth factor(VEGF) significantly increased by treatment with theFaecalibacterium prausnitziiEB-FPDK9 strain, and the expression of hapatocyte growth factor (HGF) that promotes cell regeneration and recovery, and fibroblast growth factor (FGF) that exhibits cell mitosis and survival activity, also tended to increase.

[0110] HostGeneSequenceForwardReverseHumanGAPDHGAC ATC AAG GTG AAG CAGATA CCA GGA AAT GAG CTT GAC AAAVEGFCTT CTG AGT TGC CCA GGA GAGGA TGG AGG AAG GTC AAC CAHGFAAG GCC AAG TCC CCA AAC AATCG CCG CCC TAT ATT CTG TGFGF-22GAC TCT ATG GGT CGC GGT TCTGTT GTA GCC GTT CTC GAT TSOD1CCA GTG CAG GGC ATC ATTG GCC CAC CGT GTT TTC THMOX1GCC CTT CAG CAT CCT CAG TTC CAGT GGT CAT GGC CGT GTC AAC

[0111]

[0112] 1.5 Analysis of protein expression of signaling pathways related to cell proliferation in hair papilla cells

[0113] To compare the expression level of signal transduction system proteins related to cell proliferation in papilla cells, papilla cells were seeded at 1X105cells / 500㎕ in a 24-well plate and treated withFaecalibacterium prausnitziiEB-FPDK9 strain at a concentration of 1X107cells / ㎖. Proteins were extracted and quantified withRIPA buffer containing Halt™ Protease and Phosphatase Inhibitor Cocktail (#78444, ThermoFisher) at 5, 10, 15, 30, 60 minutes, and 24 hours after treatment with theFaecalibacteriumstrain. After electrophoresis by SDS-PAGE, protein samples were reacted with primary antibodies at 4℃ for 12-18 hours and with secondary antibodies at room temperature for 1 hour. Afterwards, ECL Western Blotting Substrate (#W1001, Promega) was processed, and protein expression was observed using Fusion Solo6S (Vilber) equipment. The information on the primary and secondary antibodies used in the experiment is listed in Table 2. The results of activation of Akt and Erk, which regulate the Wnt / β-catenin signaling pathway that plays an important role in the proliferation process of hair papilla cells, and protein expression of β-catenin are shown in Fig. 3.

[0114] Referring to Fig. 3, when treated with the strain of genusFaecalibacterium(EB-FPDK9), the level of phosphorylated Akt (p-Akt) increased at 30 minutes, confirming that AKT signaling was activated. ERK, a key pathway in the MAPK signaling cascade, was confirmed to activate ERK signaling, as evidenced by an increase in phosphorylated Erk (p-Erk) levels within 5 to 10 minutes of treatment with theFaecalibacteriumstrain (EB-FPDK9). Additionally, consistent with the results showing AKT signaling activation, β-catenin expression was found to increase after 24 hours of treatment.

[0115] AntibodyTitration of antibodySource / HostCat.no. &ManufacturerPrimaryanti-β-actin1:1000Mouse#sc-47778, Santa CruzPrimaryanti-Phospho-Akt1:1000Rabbit#9271, Cell signalingPrimaryanti-Akt1:1000Rabbit#9272, Cell signalingPrimaryanti-Phospho-Ekr1 / 21:1000Rabbit#9101, Cell signalingPrimaryanti-Ekr1 / 21:1000Rabbit#9102, Cell signalingPrimaryanti-β-catenin1:500Rabbit#8480S, Cell signalingSecondaryanti-mouse IgG1:10,000Goat#31430, ThermoFisherSecondaryanti-rabbit IgG1:10,000Goat#31460, ThermoFisher

[0116]

[0117] Example 2: Analysis of antioxidant effect byFaecalibacteriumstrains in hair papilla cells

[0118] To compare the level of gene expression related to antioxidant enzymes in papilla cells, papilla cells were seeded at 1X105cells / 500㎕ in a 24-well plate and treated withFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) at a concentration of 1X107cells / ㎖. Oxidative stress was induced by exposing the cells to 0.1 mM hydrogen peroxide (H2O2) for a long period of time(24 hours) or for a short period of time (1 hour) after the strain treatment. Subsequently, the gene expression of antioxidant enzymes, SOD1 (Superoxide Dismutase 1) and HMOX1 (Heme Oxygenase 1), was confirmed. The primers used for gene analysis are listed in Table 1 above, and the results of the analysis of antioxidant enzyme gene expression in papilla cells induced with oxidative stress are shown in Fig. 4.

[0119] Referring to Fig. 4, the gene expression of SOD1, a representative antioxidant enzyme, did not change significantly under long-term H2O2-induced conditions due to treatment with the strain of genusFaecalibacterium(EB-FPDK9), whereas under conditions of short-termH2O2treatment after 18 hours of pretreatment with the strain of genusFaecalibacterium(EB-FPDK9), itwas confirmed to be at the same level as the control group, indicating that oxidative stress was immediately prevented.

[0120] Meanwhile, the gene expression of HMOX1, known as an enzyme that protects against oxidative stress, was measured and it was confirmed that it significantly increased in all cases treated withFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) compared to the H2O2treatment group, regardless of the treatment time.

[0121]

[0122] Example 3: Effect of the strain of the genusFaecalibacteriumon anagen phase promotion in mice in the telogen phase

[0123] 3.1 Strain samples

[0124] FaecalibacteriumprausnitziiEB-FPDK9 strain used in this example was prepared at a concentration of 1X109bacteria / ㎖ PBSfor use in animal experiments.

[0125]

[0126] 3.2 Animal Models

[0127] To confirm the effect of stimulating the anagen phase, 5 week-old male C57BL / 6 mice in the telogen phase were purchased from Orient Bio (Seongnam, Korea) and housed under constant brightness and temperature / humidity conditions in a specific pathogen-free (SPF) environment. After a one-week adaptation period, the back skin of 6-week-old male mice was completely removed using clippers and hair removal cream. LiveFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) was orally administered, and minoxidil was applied to the positive control group and the hair growth was observed.

[0128] Referring to Fig. 5,Faecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) was orally administered 1X108bacteria / day for 5 days a week, and phosphate-buffered saline (PBS) was orally administered as a negative control group for the same period. In the positive control group, minoxidil prepared at 2% (w / v) was applied with a brush to the backs of shaved mice for 5 days.

[0129]

[0130] 3.3 Observation of mouse hair growth

[0131] To confirm the hair growth effect of the mice, on Day 16, the mice were anesthetized and photos of the shaved areas on each mouse were taken. As stated previously, 6-week old male, C57BL / 6 mice were shaved on the dorsal surface to remove the hair and the skin was scored for skin pigmentation as an indicator of telogen (pink) or anagen (dark gray). The hair growth score was evaluated on a 7-level scale according to the darkening area under the skin just before hair growth and the area where hair grew outside the skin (hair growth area), and the evaluation criteria are shown in Table 3 (Journal of medicinal food18.3 (2015): 354-362.). The appearance photographs of the mice at the end of the experiment (on Day 16) and the changes in the hair growth score are shown in Fig. 6.

[0132] Referring to Fig. 6, the appearance of the group administered with the strain of genusFaecalibacterium(EB-FPDK9) showed prominent hair growth, and the hair growth score also increased compared to the negative control group (PBS).

[0133] scoresituation0No change (pink skin color)1< 30% darkening area230 - 70% darkening area3> 70% darkening area or < 30% hair growth area4> 70% darkening area and 30 - 70% hair growth area5> 70% darkening area and > 70% hair growth area6> 90% hair growth area

[0134]

[0135] 3.4 Mouse hair length analysis

[0136] To evaluate the efficacy of promoting hair length growth in mice, hair was randomly collected from 4 to 5 points at the end of the experiment from the area where hair had grown again. The collected hair was attached to a slide and the length was measured. The results are shown in Fig. 7. Referring to Fig. 7, it was confirmed that the hair length increased statistically significantly in the group administered with theFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9).

[0137]

[0138] 3.5 Analysis of hair follicle status in mouse skin tissue

[0139] To evaluate the efficacy of improving the hair follicle condition in mouse skin, skin tissues extracted after sacrifice were fixed in formalin. The tissues were embedded in paraffin and cut into 4 ㎛-thick tissue sections. To observe hair follicles, tissue section slides were stained with hematoxylin and eosin (H&E, ab245800, abcam) and fluorescent immunohistochemistry. H&E staining was performed according to the standard protocol, and the nucleus and cytoplasm were stained by exposing the cells to hematoxylin and eosin reagents for 1 and 5 minutes, respectively. For fluorescent immunohistochemistry, antigen retrieval of the tissues was performed with 10 mM sodium citrate buffer (pH 6.0), and endogenous peroxidase activity was inhibited with 3% (v / v) hydrogen peroxide at room temperature. Nonspecific binding was blocked with 2% (w / v) BSA buffer at room temperature. After reacting with primary antibodies at 4℃ for 16 hours, the slides were washed and treated with secondary antibodies at room temperature for 1 hour. The excess secondary antibodies were washed away, and the nuclei were stained using DAPI mounting solution (F6057, Sigma), and the slides were mounted. The antibodies used for immunofluorescence staining are shown in Table 4.

[0140] The number and diameter changes of hair follicles observed by H&E staining are shown in Fig. 8a, the ratio of hair follicles in the telogen / anagen phase is shown in Fig. 8b, and the expression level of Ki-67, a cell proliferation and anagen maintenance marker, in hair follicles is shown in Fig. 8c.

[0141] Referring to Fig. 8a, it was confirmed that the number and diameter of hair follicles in skin tissue were statistically significantly increased in the group administered withFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9). That is, as shown in Fig. 8a, similarly to the group treated with minoxidil, which is a positive control group. It was also confirmed that hair follicle formation was promoted in the group administered with strain of genusFaecalibacterium.

[0142] Referring to Fig. 8b, it was observed that the ratio of hair follicles that transitioned to the anagen phase increased in the group administered withFaecalibacterium prausnitziiEB-FPDK9 strain(EB-FPDK9). The hair growth cycle can be divided into a anagen in which hair actively grows, a catagen phase in which hair growth stops and hair follicles shrink, and a resting phase (telogen) in which hair no longer grows and prepares to fall out. While normal people have more hair in the anagen, people with alopecia have more hair in the telogen phase, which causes alopecia symptoms. Therefore, in order to treat alopecia, it is important to quickly transition hair follicles in the telogen phase to the anagen phase and to extend the shortened anagen. It can be confirmed that the formation of hair follicles is promoted and the transition from the telogen phase to the anagen phase is promoted by the composition of the present invention.

[0143] Referring to Fig. 8c, it was confirmed that the fluorescence expression level of Ki-67 increased in the hair follicles of theFaecalibacterium prausnitziiEB-FPDK9 strain administered group, and that cell division was actively progressing. Since the composition including the strain of genusFaecalibacteriumof the present invention showed significantly higher expression of Ki67 in the hair follicles than the negative control group, it could be confirmed that the strain of genusFaecalibacteriumpromotes the proliferation of hair follicles and affects the length growth and cyclical changes of hair follicles.

[0144] AntibodyTitration of antibodySource / Host1stanti-ki671:100Rabbit2ndanti-Rabbit IgG H&L(Alexa Fluor® 488)1:1000Goat

[0145]

[0146] 3.6 Analysis of hair growth stimulating factor gene expression in mouse skin tissue

[0147] To evaluate the efficacy of promoting hair growth stimulating factor gene expression in mouse skin tissue, mRNA was extracted from skin tissues excised after mouse sacrifice. The extracted mRNA was synthesized into cDNA and gene expression was analyzed in the same manner as for hair papilla cells. The primers used for gene analysis are shown in Table 5, and the results of measuring the level of hair growth stimulating factor expression in skin tissue are shown in Fig. 9.

[0148] HostGeneSequenceForwardReverseMouseGapdhGAC ATC AAG AAG GTG GTG AAG CAGATA CCA GGA AAT GAG CTT GAC AAAIgf-1GTC GTC TTC ACA CCT CTT CTA CCTGCA CAG TAC ATC TCC AGT CTC CTVegfTCT TCA AGC CAT CCT GTG TGGCG AGT CTG TGT TTT TGC AG

[0149]

[0150] Referring to Fig. 9, it was confirmed that in the group administered withFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9), insulin-like growth factor (IGF-1) and vascular endothelial growth factor (VEGF), which are involved in the regulation of cell division, differentiation, and survival, statistically significantly increased.

[0151]

[0152] Example 4: Effect ofFaecalibacteriumstrain on hair condition improvement in aged mice

[0153] 4.1 Strain samples

[0154] Faecalibacterium prausnitziiEB-FPDK9 strain used in this example was prepared at a concentration of 1X109CFU / ㎖ PBSfor use in animal experiments.

[0155]

[0156] 4.2 Animal Models

[0157] To confirm the effect of improving alopecia due to aging, 11 month-old female C57BL / 6 mice were orally administeredFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9) after a 3-month adaptation period. Referring to Fig. 11,Faecalibacterium prausnitziiEB-FPDK9 strain was orally administered 5 days a week at 1X108CFU / day, and phosphate-buffered saline (PBS) was orally administered for the same period as a negative control group. The experiment was conducted on 5 mice each for theFaecalibacterium prausnitziiEB-FPDK9 strain administration group (EB-FPDK9) and the negative control group.

[0158]

[0159] 4.3 Observation of mouse hair growth

[0160] At the end of the experiment (23 weeks), photographs of the backs of the mice were taken to confirm the improvement in alopecia due to aging, and the differences between the groups are shown in Fig. 11.

[0161] Referring to Fig. 11, at the start of the experiment, alopecia had significantly progressed in 14 month-old mice, but at the end of the experiment, the alopecia condition remained the same in the negative control group, whereas in the group administeredFaecalibacterium prausnitziiEB-FPDK9 strain (EB-FPDK9), alopecia was improved and the hair became thicker and shinier.

[0162] The specific examples described in this specification are only intended to illustrate preferred embodiments of the present invention and should not be construed as limiting the present invention. The present invention can be variously modified and changed without departing from the spirit and scope thereof, as will be apparent to those skilled in the art. The protection scope of the present invention should be determined by the appended claims, and the various modifications and variations described above are intended to be included in the protection scope of the present invention.

[0163]

[0164] [Microorganism Deposit Accession Number]

[0165] Name of depository institution: Korean Culture Center of Microorganisms

[0166] Accession number: KCCM12620P

[0167] Date of deposit: 20191101

[0168]

Claims

1.A composition comprising at least one strain of genusFaecalibacterium,a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or an extract of the lysate, and at least one pharmaceutically acceptable carrier or excipient.2.The composition of claim 1, wherein the strain of genusFaecalibacteriumis aFaecalibacteriumprausnitziistrain, Faecalibacterium spp., or a combination thereof.3.The composition of claim 2, wherein theFaecalibacterium prausnitziistrain is theFaecalibacteriumprausnitziiEB-FPDK9 strain deposited under the accession number KCCM12620P.4.The composition of claim 1, wherein the strain of genusFaecalibacteriumis a viable cell, a non-viable cell, or a combination thereof.5.The composition of claim 1, wherein the alopecia is alopecia areata, androgenetic alopecia, female pattern alopecia, middle-aged alopecia, senile alopecia, seborrheic alopecia, alopecia premature, postpartum alopecia, hypotrichosis, or chemotherapy induced alopecia.6.The composition of claim 1, wherein the composition further comprises at least one alopecia treatment agent selected from the group consisting of finasteride, dutasteride, minoxidil, episteride, alfatradiol, tofacitinib, and ruxolitinib.7.The composition of claim 1, wherein the composition further comprises at least one probiotic strain or one or more prebiotics.8.The composition of claim 1, wherein the composition comprises 1X104to 1X1012CFU / ㎖ of the strain of genusFaecalibacterium.9.The composition of claim 1, wherein the composition is a food composition.10.The composition of claim 9, wherein the food is an inner beauty food.11.A cosmetic composition comprising the genusFaecalibacterium, a culture of the strain, an endoplasmic reticulum of the strain, a lysate of the strain, an extract of the strain, an extract of the culture or lysate, and at least one physiologically acceptable carrier or excipient.12.The cosmetic composition of claim 11, whereinthe strain of genus Faecalibacteriumis aFaecalibacteriumprausnitziistrain,Faecalibacteriumspp., or a combination thereof.13.The cosmetic composition of claim 12, wherein theFaecalibacterium prausnitziistrain isFaecalibacterium prausnitziiEB-FPDK9 strain(KCCM12620P).14.The cosmetic composition of claim 11, which is formulated as a hair tonic, hair cream, hair lotion, hair shampoo, hair rinse, hair conditioner, hair spray, hair aerosol, pomade, powder, gel, hair pack, hair treatment, eyebrow tonic, eyelash tonic, eyelash nutrient or ointment.