Granted Patent B2

US 12,318,411 · App. 18/738,464 · Granted Jun 3, 2025

Inventors: Sheri Simmons (Brookline, MA); Tye Jensen (Telluride, CO); Joseph E. Kovarik (Englewood, CO)

Assignee: Seed Health, Inc.

A61K35/74A61K31/58A61K31/715A61K35/741A61K35/745A61K35/747A61K38/1709A61K38/1758C12N1/20A61K2035/11A61K2035/115

Abstract

Claims (19)

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 three different, distinct strains of Lactobacillus crispatus , 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, wherein the strains of Lactobacillus crispatus are genetically synergistic and inhibit uro-pathogenic E. coli.

2. The method of claim 1 , 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.

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

4. The method of claim 1 , wherein at least one of the three L. crispatus strains is alive.

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

6. The method of claim 1 , wherein said bacterial formulation includes at least one prebiotic having glycogen as a component thereof.

7. The method of claim 1 , wherein the bacterial formulation is applied topically and optionally further includes a moisturizer.

8. The method of claim 1 , further comprising introducing ammonia oxidizing microorganisms to the individual's vagina.

9. The method of claim 1 , wherein the bacterial formulation is isolated from the human vaginal tract of a woman.

10. The method of claim 1 , wherein the bacterial formulation is in the form of a mucoadhesive tablet suppository.

11. The method of claim 10 , wherein the mucoadhesive tablet suppository is adapted to bind to a mucosal membrane for at least 1 hour, said bioadhesive 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.

12. 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.

13. 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 Brevundimonas and Odoribacter.

14. The method as set forth in claim 1 , further comprising increasing the production of short chain fatty acids (SCFAs) in the individual's gut microbiome, while reducing the production of SCFAs in the individual's vagina.

15. 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, Veillonella, Lachnospira, Bacteroides , Peptococcus, Dialister, Gardnerella vaginalis , Atopobium, Megasphaera, Sneathia, Mycoplasma, Ureaplasma, Finegoldia , Mobiluncus, Leptotrichia, Eggerthella, Streptococcus and Clostridium.

16. The method as set forth in claim 1 , further comprising administering to the individual an extract derived from a helminth selected from the group consisting of Trichuris trichiura and Necator americanus.

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

18. A method to reduce the likelihood of a dysbiosis of the vaginal microbiome in an individual, comprising: administering to the individual a therapeutically effective amount of a bacterial formulation comprising at least three different strains of Lactobacillus crispatus , wherein the at least three strains of Lactobacillus crispatus are genetically synergistic and inhibit uro-pathogenic E. coli ; and maintaining the pH of the individual's vagina at below 4.5.

19. 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 three different strains of Lactobacillus crispatus ; administering the bacterial formulation to an individual's vagina in the form of a suppository and 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 wherein the bacterial formulation comprises live cells of Lactobacillus crispatus.

Assignments (2)

Continuity (67)

References Cited (400)