# US 12,214,005 B2 · Probiotic composition for prevention of bacterial vaginosis

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- Number: US 12,214,005 B2
- Document ID: US12214005B2
- Status: Granted
- Kind: B2
- Application number: 17/819,476
- Filed: 2022-08-12
- Published: 2022-12-01
- Granted: 2025-02-04
- Earliest claimed: 2017-07-12
- Assignees: Nederlandse Organisatie voor toegepast-natuurwetenschappelijk onderzoek TNO
- Applicants: Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno
- Inventors: Remco Kort; Charlotte Van Der Veer
- Web page: https://patentgrep.com/patent/US12214005B2

## CPC

- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/38: Cellulose; Derivatives thereof
- A61P 15/02: for disorders of the vagina
- C12N 1/20: Bacteria; Culture media therefor
- C12N 1/205: Bacterial isolates
- C12R 2001/225: Lactobacillus
- 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)
- C12R: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS

## Abstract

The present invention relates to a mixture of strains of Lactobacillus crispatus, which mixture comprises strains that have a different carbohydrate degradation profile, comprising at least one strain of L. crispatus that is able to degrade glycogen, and at least one strain of L. crispatus that is able to degrade lactose. Such a mixture is of use in the treatment or prevention of bacterial vaginosis, preferably to decrease recurrence of bacterial vaginosis after treatment with antibiotics.

## Claims

### Claim 1

A method for the treatment or prevention of bacterial vaginosis, comprising topical administration of a mixture of strains of Lactobacillus crispatus, which mixture comprises strains that have a different carbohydrate degradation profile, comprising at least one strain of L. crispatus that is able to degrade glycogen, and at least one strain of L. crispatus that is able to degrade lactose.

### Claim 2

A method of treatment or prevention of bacterial vaginosis to decrease recurrence of bacterial vaginosis after treatment with antibiotics, said method comprises a first treatment with an antibiotic compound and a second treatment with a mixture of strains of Lactobacillus crispatus, which mixture comprises strains that have a different carbohydrate degradation profile, comprising at least one strain of L. crispatus that is able to degrade glycogen, and at least one strain of L. crispatus that is able to degrade lactose.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said strains were isolated from a subject without bacterial vaginosis.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said mixture of strains in total comprises 4 or more strains of L. crispatus that differ from each other on basis of their carbohydrate degradation profile.

### Claim 5 (depends on 4)

The method according to claim 4, wherein said mixture of strains comprises at least 2 strains that are able to degrade glycogen and at least 2 strains that are able to degrade lactose.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said mixture of strains comprises at least one glycogen degrading strain chosen from CBS 142868, CBS 142871 and CBS 142874, as deposited with the Westerdijk Fungal Biodiversity Institute on Jul. 4, 2017 and CBS 142869 as deposited with the Westerdijk Fungal Biodiversity Institute on Jun. 9, 2017, and at least one lactose degrading strain chosen from CBS 142870, CBS 142871, CBS 142872, CBS 142873 and CBS 142874 as deposited with the Westerdijk Fungal Biodiversity Institute on Jul. 4, 2017.

### Claim 7

A probiotic composition comprising a mixture of strains of Lactobacillus crispatus and lactose, which mixture comprises strains that have a different carbohydrate degradation profile, comprising at least one strain of L. crispatus that is able to degrade glycogen, and at least one strain of L. crispatus that is able to degrade lactose.

### Claim 8 (depends on 7)

The probiotic composition according to claim 7, further comprising glycogen.

### Claim 9 (depends on 6)

The method according to claim 6, wherein said mixture of strains comprises at least six strains.

### Claim 10 (depends on 8)

The probiotic composition of claim 8 further comprising a carbohydrate mixture comprising two or more carbohydrates selected from the group of glycogen, galactose, glucose, lactulose, mannose, n-acetylglucosamine, cellobiose, maltose, mannose, mannitol, raffinose, trehalose, saccharose, starch, amygdalin, arbutin, salicin and esculin.

### Claim 11 (depends on 7)

A method for the treatment or prevention of bacterial vaginosis comprising topical administration of the probiotic composition according to claim 7.

### Claim 12 (depends on 7)

A method of treatment or prevention of bacterial vaginosis, said method comprising a first treatment with an antibiotic compound and a second treatment with a probiotic composition according to claim 7.

### Claim 13 (depends on 1)

The method of treatment or prevention of bacterial vaginosis according to claim 1, wherein said method decreases recurrence of bacterial vaginosis after treatment with antibiotics.

### Claim 14 (depends on 11)

The method of treatment or prevention of bacterial vaginosis according to claim 11, wherein said method decreases recurrence of bacterial vaginosis after treatment with antibiotics.
