IP Library Granted Patent US 12,005,085
Granted Patent B2
US 12,005,085 · App. 18/232,433 · Granted Jun 11, 2024

Probiotic method and composition for maintaining a healthy vaginal microbiome

Inventors: Sheri Simmons (Brookline, MA); Tye Jensen (Telluride, CO); Joseph E. Kovarik (Englewood, CO)
Assignee: Seed Health, Inc.
A61K35/74A61K31/58A61K31/715A61K38/1709A61K38/1758A61K2035/11
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,005,085
App. No.
18/232,433
Granted
Jun 11, 2024
Kind
B2
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 (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 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.

2. 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.

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 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.

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

6. 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.

7. 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.

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

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

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

16. 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.

Assignments (2)
SECURITY INTEREST Recorded Jul 21, 2026
From: SEED HEALTH, INC.
To: JPMORGAN CHASE BANK, N.A., AS LENDER
Reel/Frame 076028/0339 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2023
From: SIMMONS, SHERI; JENSEN, TYE; KOVARIK, JOSEPH E.
To: SEED HEALTH, INC.
Reel/Frame 065179/0888 →
Continuity (59)
Continuation In Part 18143399 · May 4, 2023
Continuation 17893384 · Aug 23, 2022
Continuation In Part 17694775 · Mar 15, 2022
Continuation In Part 17023736 · Sep 17, 2020
Continuation In Part 17011175 · Sep 3, 2020
Continuation In Part 16722117 · Dec 20, 2019
Continuation In Part 16229252 · Dec 21, 2018
Continuation In Part 15392173 · Dec 28, 2016
Continuation In Part 18130946 · Apr 5, 2023
Continuation In Part 18178847 · Mar 28, 2023
Continuation In Part 18087545 · Dec 22, 2022
Continuation In Part 17854422 · Jun 30, 2022
Continuation In Part 17848759 · Jun 24, 2022
Continuation In Part 17835204 · Jun 8, 2022
Continuation In Part 17567295 · Jan 3, 2022
Continuation In Part 17337600 · Jun 3, 2021
Continuation In Part 17027953 · Sep 22, 2020
Continuation In Part 16917096 · Jun 30, 2020
Continuation In Part 16782364 · Feb 5, 2020
Continuation In Part 16423375 · May 28, 2019
Continuation 16160336 · Oct 15, 2018
Continuation 15403823 · Jan 11, 2017
Continuation In Part 18103768 · Jan 31, 2023
Continuation In Part 17738771 · May 6, 2022
Continuation In Part 16904056 · Jun 17, 2020
Continuation In Part 15983250 · May 18, 2018
Continuation In Part 15384716 · Dec 20, 2016
Continuation In Part 17836079 · Jun 9, 2022
Continuation In Part 16884772 · May 27, 2020
Continuation In Part 16136950 · Sep 20, 2018
Continuation 15385278 · Dec 20, 2016
Continuation In Part 17543992 · Dec 7, 2021
Continuation In Part 16804361 · Feb 28, 2020
Continuation In Part 16020433 · Jun 27, 2018
Continuation In Part 15342642 · Nov 3, 2016
Continuation In Part 16776861 · Jan 30, 2020
Continuation 16142171 · Sep 26, 2018
Continuation In Part 15395419 · Dec 30, 2016
Continuation In Part 16426346 · May 30, 2019
Continuation 15639767 · Jun 30, 2017
Continuation In Part 15437976 · Feb 21, 2017
Continuation In Part 15228454 · Aug 4, 2016
Continuation In Part 14954074 · Nov 30, 2015
Continuation In Part 15270034 · Sep 20, 2016
Continuation In Part 14954074 · Nov 30, 2015
Continuation In Part 14574517 · Dec 18, 2014
Continuation In Part 16037053 · Jul 17, 2018
Continuation In Part 14752192 · Jun 26, 2015
Provisional Application 62275341 · Jan 6, 2016
Provisional Application 62296186 · Feb 17, 2016
Provisional Application 62387405 · Dec 24, 2015
Provisional Application 62387404 · Dec 24, 2015
Provisional Application 62260906 · Nov 30, 2015
Provisional Application 62274550 · Jan 4, 2016
Provisional Application 62072476 · Oct 30, 2014
Provisional Application 62053926 · Sep 23, 2014
Provisional Application 62014855 · Jun 20, 2014
Provisional Application 61919297 · Dec 20, 2013
Related Publication 20230390343A1 · Dec 7, 2023
Cited By (7)
US 12,257,272 US 12,279,989 US 12,318,411 US 12,318,414 US 12,329,783 US 12,357,662 US 12,533,312