Pharmaceutical composition for preventing or treating hair loss containing Akkermansia

Abstract

The present invention relates to a pharmaceutical composition, a food composition, and a cosmetic composition for preventing or treating hair loss, which contain, as an active ingredient, a strain belonging to the genus Akkermansia, the endoplasmic reticulum of the strain, the protein bodies and metabolites of the strain, a culture of the strain, a disrupted product of the strain, an extract of the strain, an extract of the culture, or an extract of the disrupted product. According to the present invention, it is possible to provide a pharmaceutical composition for preventing or treating hair loss, which is safe for the human body and has no side effects, while having an excellent hair loss prevention and hair growth promotion effect.

Description

Technical Field

[0001] The present invention relates to a pharmaceutical composition for preventing or treating hair loss, and more particularly to a pharmaceutical composition for preventing or treating hair loss containing a bacterium belonging to the genus Akkermansia as an active ingredient, a food composition for preventing or improving hair loss or promoting hair growth, and a cosmetic composition.

Background Art

[0002] As modern society develops, the number of patients with hair loss is increasing rapidly, and the age group of patients suffering from hair loss is gradually getting younger. Among people in their 20s and 30s, the number of patients suffering from hair loss is increasing rapidly.

[0003] It has been reported that the more severe the hair loss, the more psychological symptoms such as depression and anxiety are complained of, the higher the perception of stress, the more difficult it is to adapt in human relationships and opposite-sex relationships, and the less satisfactory the adaptation within the family. It has become a major insurance issue.

[0004] The cause of hair loss has not been well known so far, but reports have been made on possible causes such as genetic factors, hormonal abnormalities, and immunological abnormalities.

[0005] Male pattern alopecia (AGA) is alopecia caused by the action of male hormones on androgen-sensitive hair follicles to soften vellus hair, and it is presumed that genetic factors are greatly involved.

[0006] Female pattern alopecia is considered to be alopecia caused by a decrease in the amount of estrogen relative to androgens in the bloodstream. It often occurs after menopause. Female pattern alopecia can sometimes be improved by hormone replacement therapy, but in many cases it is refractory.

[0007] Agents that can be used for the treatment of male pattern alopecia include androgen activity inhibitors such as minoxidil and finasteride, female hormone agents such as estrogen, estradiol, and progesterone, the antifungal agent ketoconazole, pentadecane, cytokinin (6-benzylaminopurine), t-flavanone, adenosine, and others.

[0008] However, minoxidil has side effects such as drug-induced contact alopecia, hypertrichosis, decreased blood pressure, and decreased heart rate, and there is a problem that the symptoms recur immediately after discontinuation of use. On the other hand, finasteride has side effects such as prostate hyperplasia, erectile dysfunction, and ejaculatory dysfunction, and there is a side effect that the symptoms worsen after discontinuation of use.

[0009] In addition, if minoxidil is used in high doses by women, there may be a risk of hirsutism and giving birth to a deformed baby, and finasteride has a risk of giving birth to a deformed baby, and it is actually prohibited from being administered to women, especially pregnant women.

[0010] In addition, there are various hair loss products containing components aimed at promoting blood circulation, strengthening hair follicle function, moisturizing the scalp, preventing dandruff, photoxidation effect, and extending the hair growth phase as active ingredients. However, there are few products that have still proven to be significantly effective in terms of effects from such conventional formulations, and side effect problems may also be raised.

[0011] On the other hand, as an effort to obtain an anti-hair loss effect by using microorganisms, Patent Document 1 discloses a hair loss treatment agent obtained by fermenting wild rice and malt using microorganisms such as Lactobacillus plantarum and then adding raw materials such as Saururus chinensis and Houttuynia cordata. Patent Document 2 discloses a pharmaceutical composition for treating prostatic hyperplasia or alopecia or for treating, containing lactic acid bacteria belonging to the genus Enterococcus as an active ingredient. However, among such compositions, there has been no meaningful hair loss treatment effect so far.

Prior Art Documents

Patent Documents

[0012]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0013] The present invention is for solving the above problems, and one object of the present invention is to provide a pharmaceutical composition for preventing or treating hair loss, which has excellent hair loss prevention, hair growth, or hair growth promoting effects while being safe for the human body and having no side effects.

[0014] Another object of the present invention is to provide a food composition for preventing or improving alopecia, which contains Akkermansia live bacteria, dead bacteria, or a mixture thereof as an active ingredient.

[0015] Another object of the present invention is to provide a cosmetic composition that can prevent, relieve, and prevent scalp aging, thereby preventing, relieving, and improving hair loss, and promoting hair growth or hair growth.

Means for Solving the Problems

[0016] In order to achieve the above objects of the present invention, the present invention provides a pharmaceutical composition for preventing or treating hair loss, which contains Akkermansia strains, endoplasmic reticulum of the strains, protein bodies and metabolites of the strains, cultures of the strains, disrupted products of the strains, extracts of the strains, extracts of the cultures or extracts of the disrupted products, and at least one pharmaceutically acceptable excipient.

[0017] The Akkermansia strain may be Akkermansia muciniphila EB-AMDK19 (KCTC 13761BP) strain. The Akkermansia strain may be live bacteria, dead bacteria, or a mixture thereof.

[0018] The pharmaceutical composition for preventing or treating hair loss of the present invention can be used for treating one or more hair loss diseases selected from the group consisting of androgenetic alopecia, telogen effluvium, alopecia areata, alopecia totalis, hypotrichosis, hereditary hypotrichosis simplex, frontal fibrosing alopecia, cicatricial alopecia, lichen planopilaris, ring alopecia, scarring alopacia, nonscarring alopacia, chemotherapy induced alopecia, and alopecia universalis.

[0019] The pharmaceutical composition for preventing or treating hair loss of the present invention may further contain at least one hair loss treatment agent selected from the group consisting of finasteride, dutasteride, minoxidil, episteride, alfatradiol, tofacitinib, and ruxolitinib, in addition to Akkermansia strains.

[0020] Another aspect of the present invention relates to a food composition for preventing or improving hair loss, which contains Akkermansia strains, endoplasmic reticulum of the strains, protein bodies and metabolites of the strains, cultures of the strains, disrupted products of the strains, extracts of the strains, extracts of the cultures or disrupted products, and at least one physiologically acceptable excipient, diluent, or carrier.

[0021] Another aspect of the present invention relates to a hair loss prevention or hair growth promoting cosmetic composition comprising an Akkermansia genus strain, the endoplasmic reticulum of the strain, the protein bodies and metabolites of the strain, a culture of the strain, a disrupted product of the strain, an extract of the strain, an extract of the culture or a disrupted product of the extract, and at least one cosmetically acceptable excipient, diluent, or carrier.

Advantages of the Invention

[0022] According to various embodiments of the present invention, it is possible to provide a pharmaceutical composition for preventing or treating hair loss that is excellent in hair loss treatment and hair growth promoting effects and has almost no side effects.

[0023] The pharmaceutical composition for preventing or treating hair loss of the present invention has an effect of preventing and preventing the phenomenon of hair loss from the scalp or the phenomenon of thinning or thinning of hair.

[0024] The food composition of the present invention not only has a hair growth function of generating new hair or a function of promoting the hair growth, but also has an effect of promoting the delay of the hair cycle from the growth phase to the regression phase, so that the conventional hair grows vigorously.

[0025] The cosmetic composition containing the live Akkermansia genus bacteria, dead bacteria, inactivated or pasteurized mixtures thereof of the present invention can prevent, alleviate and prevent scalp aging, thereby improving the hair loss prevention effect, and can provide a remarkable effect of promoting hair growth or hair growth.

Brief Description of the Drawings

[0026]

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Figure 2a

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Figure 5b

Mode for Carrying Out the Invention

[0027] Hereinafter, embodiments of the present invention will be described in detail. In describing the present invention, when it is determined that a specific description of a related known configuration or function may obscure the gist of the present invention, the detailed description thereof will be omitted.

[0028] Throughout this specification and the entire scope of the claims, unless otherwise stated, the term "comprise" or "comprising" means including the thing, step or group of things mentioned, and is not used in the sense of excluding any other thing, step or group of things, or group of steps.

[0029] As used in this specification, terms such as "treat" and "treatment" mean alleviating symptoms temporarily or permanently, removing the cause of symptoms, or preventing or delaying the onset of symptoms of a disease or pathological condition.

[0030] As used herein, the term "prevention" means all acts of suppressing hair loss or delaying the onset of a disease by administration of a pharmaceutical composition according to the present invention.

[0031] As used herein, the term "amelioration" means all acts of reducing parameters related to an abnormal state, such as the degree of symptoms.

[0032] As used herein, the term "pharmaceutically acceptable" means a composition that has a reasonable benefit / risk ratio without excessive toxicity, irritation, allergic reaction, or other problems or complications, is compatible with contact with the tissues of a subject (e.g., a human), and is within the scope of sound medical judgment.

[0033] As used herein, "hair loss" means the phenomenon of hair falling out from the scalp or the phenomenon of hair becoming thin or fine. Hair loss herein may include androgenetic alopecia, telogen effluvium, anagen effluvium, alopecia areata, drug-induced telogen effluvium, postpartum telogen effluvium, etc. In addition, it may include all types of hair loss that form abnormal hair loss patterns such as the softening of terminal hair due to a series of factors, the conversion of tufted hair to single hair, and the atrophy of hair follicles.

[0034] As used herein, "promoting hair growth" means not only the hair growth function of generating new hair or the function of promoting hair growth, but also the function of promoting the delay from the growth phase to the regression phase and making the conventional hair grow vigorously.

[0035] One aspect of the present invention relates to a pharmaceutical composition for preventing or treating hair loss, comprising Akkermansia strains, endoplasmic reticulum of the strains, protein bodies and metabolites of the strains, cultures of the strains, disrupted products of the strains, extracts of the strains, extracts of the cultures or extracts of the disrupted products.

[0036] Any of the Akkermansia genus strains that are commonly known can be used. For example, Akkermansia muciniphila strains can be used. In this specification, examples of Akkermansia genus strains include the Akkermansia muciniphila EB-AMDK19 strain isolated and deposited by the applicant. Specifically, it is preferable to use the Akkermansia muciniphila EB-AMDK19 strain deposited by the applicant with the Korea Research Institute of Bioscience and Biotechnology (KCTC) on December 05, 2018, and assigned the accession number KCTC13761BP under the Budapest Treaty.

[0037] The Akkermansia genus strain can be viable, dormant, inactivated, pasteurized, or a dead cell body or a mixture thereof. The term "dead cell body" used herein means a strain inactivated by heat treatment. In one embodiment, the Akkermansia genus dead cell body of the present invention is preferably produced by heat-treating the Akkermansia genus strain at a temperature of 50°C to 100°C, preferably 60°C to 95°C, more preferably 70°C to 90°C for 5 minutes to 1 hour, but not limited thereto. The higher the heat treatment temperature, the shorter the heat treatment time can be.

[0038] The pharmaceutical composition for preventing or treating hair loss of the present invention contains viable Akkermansia muciniphila, dead cell bodies, or a mixture thereof in an amount in the range of about 1×10 2 to about 1×10 15 CFU, preferably about 1×10 4 to about 1×10 12 CFU, more preferably about 1×10 5 to about 1×10 10 CFU, even more preferably about 1×10 6 to about 1×10 9 CFU. If the volume of the strain is less than the above range, there is a problem that it is difficult to exert a sufficient hair loss prevention and hair growth promotion effect. If the volume of the strain exceeds the above range, it is difficult to expect an additional increase in effect.

[0039] In the present invention, Akkermansia live bacteria, dead bacteria, and mixtures thereof are substantially purified. The substantially purified Akkermansia live bacteria, dead bacteria, and mixtures thereof may be contained in a sample at least about 50%, preferably at least about 60%, 70%, 80%, 90%, 95%, 99%, or more.

[0040] The pharmaceutical composition of the present invention can be used for the treatment of one or more types of alopecia selected from androgenetic alopecia, telogen effluvium, alopecia areata, alopecia totalis, hypotrichosis, hereditary simple hypotrichosis, frontal fibrosing alopecia, cicatricial alopecia, lichen planopilaris, annular alopecia, cicatricial alopecia, non-cicatricial alopecia, chemotherapy-induced alopecia, or alopecia universalis.

[0041] The pharmaceutical composition of the present invention may further contain at least one hair loss treatment agent selected from the group consisting of finasteride, dutasteride, minoxidil, epistiride, alpha-tocopherol, tofacitinib, and ruxolitinib. The Akkermansia sp. strain of the present invention can be administered simultaneously as one formulation with the hair loss treatment agent, or can be administered simultaneously or sequentially as separate formulations.

[0042] The pharmaceutical composition for preventing or treating hair loss of the present invention not only exhibits an excellent hair loss prevention effect when administered alone, but also reduces the side effects of hair loss treatment agents and further activates the efficacy when administered in combination with hair loss treatment agents such as minoxidil and finasteride, and has a better therapeutic effect than when they are administered alone.

[0043] In one embodiment of the present invention, the culture of the Akkermansia strain includes a culture medium or a culture solution, and means a culture product and its concentrate containing some or all of the substances contained in the medium in which the strain is cultured. For example, it can mean metabolites or secretions that are the results of strain culture, and their disruptions, and the strain itself is also contained in the culture.

[0044] In one embodiment of the present invention, the crushed product of the Akkermansia strain may be a product obtained by crushing the strain itself by chemical or physical forces.

[0045] In one embodiment of the present invention, the extract may mean a product obtained by extracting the strain itself, the endoplasmic reticulum of the strain, the protein bodies and metabolites of the strain, the culture of the strain, the crushed product of the strain, or a mixture thereof, and is a broad concept including any substances obtained by processing or treating by other methods after extraction. Specifically, the extract may be an ethanol fraction or an ethanol precipitate.

[0046] The pharmaceutical composition of the present invention may contain a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier includes lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methyl hydroxybenzoate, propyl hydroxybenzoate, talc, magnesium, magnesium stearate, and mineral oil, etc.

[0047] It also includes diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants.

[0048] The pharmaceutical composition can be formulated into oral formulations such as powders, granules, capsules, suspensions, emulsions, syrups, aerosols, etc., parenteral formulations, injection forms, and topical administration formulations by ordinary methods.

[0049] Among the oral formulations, the oral solid formulations include tablets, pills, powders, granules, capsules, etc. Such solid formulations may contain at least one excipient, for example, starch, calcium carbonate, sucrose or lactose, gelatin, etc., and may contain lubricants such as magnesium stearate, talc.

[0050] Among oral preparations, oral liquid preparations include suspensions, internal liquids, emulsions, syrups, etc., and may contain diluents such as water and liquid paraffin, wetting agents, sweeteners, flavoring agents, preservatives, etc. Parenteral preparations include sterilized aqueous solutions, non-aqueous solvents, suspensions, emulsions, and lyophilized preparations. Non-aqueous solvents and suspensions include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate, etc.

[0051] In addition, the pharmaceutical composition can be administered to mammals including or excluding humans by various routes, for example, orally, intravenously, intramuscularly, or subcutaneously.

[0052] In the present invention, the composition can be administered topically. Topical administration means the direct application of the active ingredient or composition (such as a topical skin composition) to the skin and / or hair.

[0053] The topical composition of the present invention can be in the form of a solution, lotion, wax paste, cream, ointment, liposome, spray, gel, foam, roller stick, or any other dosage form commonly used in dermatology.

[0054] In the pharmaceutical composition of the present invention, the dosage of the active ingredient can vary depending on the patient's condition and body weight, the degree of the disease, the form of the drug, the administration route, the period, etc., but can be appropriately selected in some cases.

[0055] The preferred dosage of the pharmaceutical composition of the present invention can 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, body weight, gender, age, severity of the patient, and administration route.

[0056] The administration can be administered once a day or divided into several times a day. Such a dosage should not be construed as limiting the scope of the present invention in any way.

[0057] Another aspect of the present invention relates to a food composition for preventing or suppressing hair loss and promoting hair growth. The food composition of the present invention contains Akkermansia genus strains, endoplasmic reticulum of the strains, protein bodies and metabolites of the strains, cultures of the strains, disrupted products of the strains, extracts of the strains, extracts of the cultures or disrupted products, and at least one physiologically acceptable excipient, diluent, or carrier. The Akkermansia genus strains can be viable bacteria, dormant, inactivated, pasteurized, or dead cells or mixtures thereof.

[0058] In the present invention, any Akkermansia genus strain can be used. As an example, Akkermansia muciniphila strain can be used. In this specification, specific examples of the Akkermansia genus strains include Akkermansia muciniphila EB-AMDK19 strain isolated and deposited by the applicant.

[0059] The food composition of the present invention can be manufactured as a functional food such as a functional beverage, a health supplement food, or a food for special nutritional supplementation. The form of the food can be beverages such as tea, juice, carbonated beverages, ionic beverages, processed dairy products such as milk and yogurt, gums, mochi, traditional confectioneries, bread, confectioneries, noodles, and other foods, or health functional food preparations such as powders, tablets, and capsules.

[0060] The food composition of the present invention may contain, in addition to its active ingredients, sweeteners, flavoring agents, bioactive components, minerals, and the like.

[0061] The sweetener can be used in an amount that makes the food have an appropriate sweetness and can be natural or synthetic. Examples of natural sweeteners include sugar sweeteners such as corn syrup solids, honey, sucrose, fructose, lactose, and maltose.

[0062] Flavoring agents can be used to improve taste and aroma, and both natural and synthetic ones can be used. Preferably, natural ones are used. When using natural ones, the purpose of nutritional enhancement can also be pursued in parallel with flavor. Natural flavoring agents can be obtained from apples, lemons, citrus fruits, grapes, strawberries, peaches, etc., or can be obtained from tea leaves, amadokoro, bamboo leaves, cinnamon, chrysanthemum leaves, jasmine, etc.

[0063] In addition, those obtained from Korean ginseng (red ginseng), shiitake mushrooms, aloe vera, ginkgo, etc. can be used. For synthetic flavoring agents, esters, alcohols, aldehydes, terpenes, etc. can be utilized.

[0064] As physiologically active substances, catechins such as catechin, epicatechin, gallocatechin, epigallocatechin, and vitamins such as retinol, ascorbic acid, tocopherol, calciferol, thiamine, riboflavin can be used.

[0065] As minerals, calcium, magnesium, chromium, cobalt, copper, fluoride, germanium, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, silicon, sodium, sulfur, vanadium, zinc, etc. can be used.

[0066] In addition, the food composition of the present invention can contain preservatives, emulsifiers, acidulants, thickeners, etc. as necessary in addition to the above-mentioned sweeteners. Such preservatives, emulsifiers, etc. are known in the art, and any of those known in the art can be used.

[0067] Another aspect of the present invention can be a cosmetic composition, which may contain the Akkermansia genus strain, preferably the Akkermansia muciniphila strain. The cosmetic composition may include the Akkermansia muciniphila EB-AMDK19 strain (KCTC 13761BP), the endoplasmic reticulum of these strains, the protein bodies and metabolites of the strains, the cultures of the strains, the disrupted products of the strains, the extracts of the strains, the extracts of the cultures or the disrupted products, and at least one cosmetically acceptable excipient, diluent, or carrier. The Akkermansia genus strain can be viable, dormant, inactivated, pasteurized, or dead cells or a mixture thereof.

[0068] The cosmetic composition of the present invention can be manufactured in various forms by the usual manufacturing methods of cosmetics. Specifically, the cosmetic composition can be manufactured in dosage forms such as hair tonic, hair cream, hair lotion, hair shampoo, hair rinse, hair conditioner, hair spray, air aerosol, foam, powder, gel, hair pack, hair treatment, eyebrow hair growth agent, eyelash hair growth agent, eyelash nutrient, or ointment.

[0069] In addition, the cosmetic composition may contain ordinary adjuvants such as stabilizers, solubilizers, vitamins, pigments, and fragrances commonly used in the field of cosmetic compositions, and may contain a cosmetically acceptable carrier.

[0070] Cosmetically acceptable carriers include, but are not limited to, purified water, oils, waxes, fatty acids, fatty alcohols, fatty acid esters, surfactants, humectants, thickeners, viscosity stabilizers, chelating agents, buffers, preservatives, lower alcohols, etc. Moisturizers, anti-inflammatory agents, antibacterial agents, antifungal agents, vitamins, sunscreen agents, antibiotics, perfumes, and dyes may be included if necessary.

[0071] Summarizing the above results, the hair loss prevention or treatment agent composition according to the present invention not only has excellent efficacy as a hair loss prevention or treatment agent, but also can alleviate and improve hair loss that can be accelerated by preventing, alleviating, and preventing scalp aging.

[0072] Hereinafter, the present invention will be described in detail with reference to examples. However, the following examples are merely illustrative for helping a general understanding of the present invention, and the content of the present invention is not limited to the following examples.

[0073] Example Example 1 1.1. Strain sample The Akkermansia muciniphila EB-AMDK19 (KCTC13761BP) live bacteria used in this test were prepared at a concentration of 1x10 8 CFU / 100 μl PBS (25% glycerol, 0.05% cysteine / PBS).

[0074] 1.2. Animal experiment Animal experiments were conducted in accordance with the Animal use and Care Protocol of the Institutional Animal Care and Use Committee (IACUC). Male C57BL / 6 mice at 7 weeks of age were purchased and after a one-week adaptation period, they were bred for 5 weeks. The breeding environment was maintained at a constant temperature (22°C) and relative humidity (40 - 60%), and they were bred while adjusting light and darkness in a 12-hour cycle. A normal diet (chow diet) was given to all experimental groups.

[0075] 1.3. Administration of sample and setting of experimental groups As shown in Table 1 below, the mice were divided into four groups (8 mice / group), and each drug was subcutaneously injected and orally administered to the mice 5 times a week for 5 weeks. To create a hair loss model, testosterone was subcutaneously injected into the mice in all experimental groups at a dose of 0.5 mg / day. The group in which hair loss was induced by testosterone administration was used as the negative control group, and finasteride was orally administered to the positive control group at a dose of 0.5 mg / kg / day. In the group administered with the live and heat-killed Akkermansia bacteria of the present invention, PBS containing L-cysteine and glycerol was orally administered as a vehicle.

[0076]

Table 1

[0077] Test Example 1: Experiment for confirming mouse hair growth photos For the mice in each experimental group, the degree of hair growth was observed by taking hair photos. Fig. 1 shows the hair growth and regrowth of the hair loss-induced mice over the number of days of sample application in a photograph. From the left, the results are those of the negative control group (Testosterone), the positive control group (T+Finasteride), the live Akkermansia muciniphila-administered group (T+EB-AMDK19), and the heat-killed Akkermansia muciniphila-administered group (T+EB-AMDK19 HI). By applying 100 μl of the sample to each group once a day for 5 weeks, it was confirmed whether hair growth occurred at the hairless site on the back of the mice.

[0078] As confirmed through Fig. 1, the finasteride-treated group, which is the positive control group, showed a result where the skin color changed dark at the end of the 3rd week of treatment, indicating the expected growth of hair shafts. As time passed, the range gradually expanded, and it was shown that almost all parts turned black by the 5th week.

[0079] In the negative control group (Testosterone), the skin color was maintained pink until the 5th week when the observation ended, indicating that hair did not grow in almost all parts.

[0080] In the mice to which a sample containing live Akkermansia muciniphila was applied, a bluish-black skin color was observed starting from the tail in the area where hair loss occurred one week after application. This indicates a result where hair growth is expected to occur faster than in the case of the positive control group. As a result, significant hair growth occurred in the lower body part where hair loss occurred starting from the third week of application.

[0081] On the other hand, in the case of mice to which a dead cell sample of Akkermansia muciniphila was applied, a bluish-black skin color was partially observed in the center of the area where hair loss occurred one week after application, similar to the live cell administration group. Significant hair growth occurred in the lower body part where hair loss occurred starting from the fourth week of application.

[0082] Test Example 2. Effect of increasing hair growth length After the five-week experiment was completed, the hair length was measured for each experimental group according to the treatment type, and the average value was calculated. The experimental results of the increased hair growth length effect are shown as a graph in Figure 2.

[0083] Referring to Figure 2a and Figure 2b, first, it can be seen that in the case of the negative control group to which distilled water was applied, no changes such as a rapid increase in hair length occurred.

[0084] The hair lengths of the finasteride administration group, which is the positive control group (T+Finasteride), and the live Akkermansia administration group (T+EB-AMDK19) showed a similar pattern, while in the case of the group administered with dead Akkermansia cells (T+EB-AMDK19 HI), the hair length was relatively short.

[0085] As a result, as can be seen from Figure 2a-b, it was confirmed that the hair length increased significantly in both the live and dead cell treatments compared to the control group (Control) by the treatment with Akkermansia strains.

[0086] Test Example 3. Measurement of body weight and tissue weight After the five-week experiment was completed, the mice in each group were sacrificed, and then the liver and prostate tissues were removed and weighed. The results are shown in Figure 3a-c. The prostate was photographed and compared (see Figure 4).

[0087] There was no change in the body weight of the mice in each group, and there was no significant difference in the weights of the liver and prostate. There was also no significant change in the size of the prostate.

[0088] Test Example 4: Experiment for measuring histological changes in mouse hair follicles To confirm the morphological changes in the hair follicles of male C57BL / mice, the skin tissues collected at the 5th week of transdermal administration were stained with hematoxylin and eosin, observed under an optical microscope to confirm the number of hair follicles, and the results are shown in FIGS. 5a and 5b.

[0089] As a result of measuring the number of telogen hair follicles by sample treatment in C57BL / mice induced with alopecia, as shown in FIGS. 5a-c, it can be confirmed that when treated with finasteride, the number of telogen hair follicles increased compared to the negative control group.

[0090] On the other hand, when the Akkermansia genus strain (live bacteria) of the present invention was administered, it can be confirmed that the number of telogen hair follicles increased significantly compared to the negative control group. In particular, when the Akkermansia genus strain (dead bacteria) of the present invention was administered, it can be confirmed that the number of telogen hair follicles increased significantly.

[0091] The above description merely exemplarily explains the technical idea of the present invention. Those with ordinary knowledge in the technical field to which the present invention pertains should be able to make various modifications and deformations without departing from the essential characteristics of the present invention. The true protection scope of the present invention should be analyzed by the following claims, and all technical ideas within the equivalent scope should be construed as being included in the scope of rights of the present invention.

Deposit Number

[0092] Name of the depository institution: Korea Research Institute of Bioscience and Biotechnology Deposit number: KCTC13761BP Date of deposit: 20181205 TIFF2025520596000003.tif162170

Claims

1. A pharmaceutical composition for preventing or treating hair loss, comprising a strain belonging to the genus Akkermansia, endoplasmic reticulum of the strain, protein bodies and metabolites of the strain, a culture of the strain, a disrupted product of the strain, an extract of the strain, an extract of the culture or a disrupted product of the extract, and at least one pharmaceutically acceptable excipient. A pharmaceutical composition for preventing or treating hair loss.

2. The strain belonging to the genus Akkermansia is Akkermansia muciniphila strain. The pharmaceutical composition for preventing or treating hair loss according to Claim 1.

3. The strain belonging to the genus Akkermansia muciniphila is Akkermansia muciniphila EB-AMDK19 strain deposited under the accession number KCTC 13761BP. The pharmaceutical composition for preventing or treating hair loss according to Claim 2.

4. The strain belonging to the genus Akkermansia is a viable bacterium, dormant, inactivated, pasteurized, or a dead cell body or a mixture thereof. The pharmaceutical composition for preventing or treating hair loss according to Claim 1.

5. The composition is for treating one or more hair loss disorders selected from the group consisting of androgenetic alopecia, telogen effluvium, alopecia areata, alopecia totalis, hypotrichosis, hereditary hypotrichosis simplex, frontal fibrosing alopecia, cicatricial alopecia, lichen planopilaris, ring alopecia, scarring alopacia, nonscarring alopacia, chemotherapy-induced alopecia, and alopecia universalis. The pharmaceutical composition for preventing or treating hair loss according to Claim 1.

6. The composition further comprises at least one hair loss therapeutic agent selected from the group consisting of finasteride, dutasteride, minoxidil, episteride, alfatradiol, tofacitinib, and ruxolitinib. The pharmaceutical composition for preventing or treating hair loss according to claim 1.

7. Comprising Akkermansia strains, endoplasmic reticulum of said strains, protein bodies and metabolites of said strains, cultures of said strains, disrupted products of said strains, extracts of said strains, extracts of said cultures or disrupted products, and at least one physiologically acceptable excipient, diluent, or carrier. A food composition for preventing or improving hair loss.

8. The Akkermansia strain is Akkermansia muciniphila strain. The food composition for preventing or improving hair loss according to claim 7.

9. The Akkermansia muciniphila strain is Akkermansia muciniphila EB-AMD-K19 (KCTC 13761BP). The food composition for preventing or improving hair loss according to claim 8.

10. The food composition contains from 1×10 4 to about 1×10 12 CFU / ml of Akkermansia strains, The food composition for preventing or improving hair loss according to claim 7.

11. Comprising Akkermansia strains, endoplasmic reticulum of said strains, protein bodies and metabolites of said strains, cultures of said strains, disrupted products of said strains, extracts of said strains, extracts of said cultures or disrupted products, and at least one cosmetically acceptable excipient, diluent, or carrier. A cosmetic composition for preventing hair loss or promoting hair growth.

12. The Akkermansia strain is Akkermansia muciniphila strain. The cosmetic composition for preventing hair loss or promoting hair growth according to claim 11.

13. The Akkermansia muciniphila strain is Akkermansia muciniphila EB-AMD-K19 (KCTC 13761BP) strain. The cosmetic composition for preventing hair loss or promoting hair growth according to claim 12.

14. The dosage form of the composition is a hair tonic, hair cream, hair lotion, hair shampoo, hair rinse, hair conditioner, hair spray, air aerosol, foam, powder, gel, hair pack, hair treatment, eyebrow hair growth agent, eyelash hair growth agent, eyelash nutrient, or ointment. The cosmetic composition for preventing hair loss or promoting hair growth according to claim 11.

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