# US 12,005,085 B2 · Probiotic method and composition for maintaining a healthy vaginal microbiome

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- Number: US 12,005,085 B2
- Document ID: US12005085B2
- Status: Granted
- Kind: B2
- Application number: 18/232,433
- Filed: 2023-08-10
- Published: 2023-12-07
- Granted: 2024-06-11
- Earliest claimed: 2013-12-20
- Assignees: Seed Health, Inc.
- Applicants: Seed Health, Inc.
- Inventors: Sheri Simmons; Tye Jensen; Joseph E. Kovarik
- Web page: https://patentgrep.com/patent/US12005085B2

## CPC

- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms}
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 31/58: containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin (digitoxin {A61K31/7048})
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61K 31/715: Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 38/1709: {from mammals}
- A61K 38/1758: {p53}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 15/02: for disorders of the vagina
- C12N 1/20: Bacteria; Culture media therefor
- C12N 1/38: Chemical stimulation of growth or activity by addition of chemical compounds which are not essential growth factors; Stimulation of growth by removal of a chemical compound (C12N1/34 takes precedence)
- A61K 2035/11: {Medicinal preparations comprising living procariotic cells}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A method to reduce the likelihood of a dysbiosis of the vaginal microbiome in an individual employing a probiotic method and composition for maintaining a healthy vaginal microbiome, with particular embodiments including a bacterial formulation of at least two live bacteria selected from the group consisting of L. reuteri, L johnsonii and L. crispatus, and at least one prebiotic having glycogen as a component thereof. The bacterial formulation is administered to an individual's vagina in an amount sufficient for the bacterial formulation to generate an amount of tryptophan metabolites sufficient to act as aryl hydrocarbon receptor (AHR) agonists, thereby reducing inflammation in the individual's vagina. Certain embodiments include increasing the production of SCFAs in the individual's gut microbiome, while reducing the production of SCFAs in the individual's vagina and introducing ammonia oxidizing microorganisms to the individual's vagina.

## Claims

### Claim 1

A method to reduce the likelihood of a dysbiosis of the vaginal microbiome in an individual, comprising:
providing a bacterial formulation that includes at least two of a live bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus johnsonii and Lactobacillus crispatus, wherein said bacterial formulation includes at least one prebiotic having glycogen as a component thereof;
administering the bacterial formulation to an individual's vagina in an amount sufficient for the bacterial formulation to generate an amount of tryptophan metabolites sufficient to act as aryl hydrocarbon receptor (AHR) agonists to thereby reduce inflammation in the individual's vagina; and
administering to the individual an extract derived from a helminth selected from the group consisting of Capillaria hepatica, Dicrocoelium dendriticum, Ascaris lumbricoides, Enterobius vermicularis, Trichuris trichiura, Ancylostoma duodenale, Necator americanus, Strongyloides stercoralis, Haemonchus contortus, and Trichinella spiralis.

### Claim 2 (depends on 1)

The method of claim 1, wherein the bacterial formulation includes Lactobacillus crispatus and optionally further includes a moisturizer, and wherein the bacterial formulation is applied to an individual's vagina at night so that it remains thereon during a sleeping pattern of the individual.

### Claim 3 (depends on 1)

The method as set forth in claim 1, further comprising administering at least one of tomatidine and rapamycin to the individual.

### Claim 4 (depends on 3)

The method of claim 3, wherein at least one of tomatidine and rapamycin are administered by using a bioadhesive strip that has a first and second side, the second side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour, said strip including at least one polymer selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, sodium alginate, polyethylene glycol, tragacanth gum, guar gum, acacia gum, arabic gum, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, chitin, chitosan, levan, elsinan, collagen, zein, gluten, soy protein isolate, whey protein isolate, casein and mixtures thereof.

### Claim 5 (depends on 1)

The method as set forth in claim 1, wherein the individual is a postmenopausal woman.

### Claim 6 (depends on 1)

The method as set forth in claim 1, further comprising, prior to the step of providing said bacterial formulation, reducing the number of bacteria in the individual using one of an antibiotic, a clustered regularly interspaced short palindromic repeats (CRISPR) CRISPR associated protein (Cas) system or a CRISPR from Prevotella and Francisella 1 (Cpf1) system.

### Claim 7 (depends on 1)

The method as set forth in claim 1, further comprising increasing in the individual's vagina a population of bacteria selected from the group consisting of bacteria of the genera Lactobacillus, Brevundimonas, and Odoribacter and decreasing a population of bacteria of the genus Streptococcus.

### Claim 8 (depends on 1)

The method as set forth in claim 1, further comprising reducing in the individual's vagina a population level of the bacterium Gardnerella vaginalis.

### Claim 9 (depends on 1)

The method as set forth in claim 1, further comprising preserving mucus in the individual's vagina by reducing a population of bacteria in the individual's vagina selected from the group consisting of Prevotella, Gardnerella, and Bacteroides.

### Claim 10 (depends on 1)

The method as set forth in claim 1, further comprising, during a seventh month of pregnancy, reducing a population of Veillonella and Lachnospira bacteria in the individual's vagina so as to reduce a risk of a newborn infant developing one of infantile asthma, wheezing and allergies.

### Claim 11 (depends on 1)

The method as set forth in claim 1, further comprising increasing a level of butyrate in a gut microbiome of the individual and providing tributyrin to said individual.

### Claim 12 (depends on 1)

The method as set forth in claim 1, further comprising reducing a population in the individual's vagina of at least two bacteria selected from the group consisting of Peptococcus, Dialister, Gardnerella vaginalis, Bacteroides and Clostridium.

### Claim 13 (depends on 1)

The method as set forth in claim 1, further comprising reducing the amount of short chain fatty acid (SCFA) production in the individual's vagina by reducing a population of at least two of the following: Streptococcus, Bacteroides, Prevotella, Mycoplasma, Ureaplasma, Finegoldia, Mobiluncus, Leptotrichia, Eggerthella, Veillonella, Dialister, Atopobium, Megasphaera, Sneathia, C. albicans and Gardnerella vaginalis.

### Claim 14 (depends on 1)

The method as set forth in claim 1, further comprising increasing the production of SCFAs in the individual's gut microbiome, while reducing the production of SCFAs in the individual's vagina.

### Claim 15 (depends on 1)

The method as set forth in claim 1, further comprising introducing ammonia oxidizing microorganisms to the individual's vagina.

### Claim 16 (depends on 1)

The method as set forth in claim 1, further comprising, using probiotics, reducing hypoxic conditions of the individual's vagina to reduce an existing population of anaerobic bacteria in their vagina.