Vaginal Microbiota Preparation for Colonization
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Solution Overview
Problem
Current lactobacillus-based products for vaginal health are often ineffective due to poor colonization and transient therapeutic effects, as they fail to establish a sustained microbiome balance in the vaginal niche, primarily due to the use of unsuitable strains and inability to adapt to the vaginal environment.
Innovation Solution
Development of substantially complete vaginal microbiota preparations comprising a combination of Lactobacillus species such as Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, and Lactobacillus gasseri, which comprise 80-99.9% of the preparation, along with less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp., designed to effectively colonize and maintain a healthy vaginal microbiota.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If single strains of Lactobacillus are used in vaginal products, then the product can be manufactured with simple composition, but the colonization ability in the vaginal niche is poor and therapeutic effects are transient
Solution Approach 1:
The patent combines multiple Lactobacillus species (L. crispatus, L. iners, L. gasseri, L. jensenii) into a single vaginal microbiota preparation. This merging of different bacterial strains creates a more complex but ecologically suitable composition that can effectively colonize the vaginal niche and provide sustained therapeutic effects, resolving the contradiction between simple manufacturing and effective colonization.
2Ease of manufacture
If ecologically unsuitable strains are used, then the product can be produced with standard procedures, but the strains cannot adapt to the vaginal environment and fail to maintain colonization
Solution Approach 1:
The patent selects specific Lactobacillus species that are locally adapted to the vaginal environment. By choosing strains that naturally inhabit and thrive in the vaginal niche (L. crispatus, L. iners, L. gasseri, L. jensenii), the product achieves both manufacturability and ecological suitability, allowing the bacteria to adapt to and maintain colonization in the vaginal environment.
3Device complexity
If in vitro selected strains with promising characteristics are used, then the product can be developed with clear selection criteria, but the strains fail to engraft in vivo and provide sustained therapeutic effect
Solution Approach 1:
The patent performs preliminary selection of Lactobacillus species based on their known ecological suitability for the vaginal niche before in vivo administration. By pre-selecting strains that are known to thrive in the vaginal environment (L. crispatus, L. iners, L. gasseri, L. jensenii), the product ensures both clear selection criteria and sustained therapeutic effects, resolving the contradiction between selection simplicity and treatment durability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The preparations effectively colonize the vaginal niche, maintaining a healthy balance and reducing pathogenic bacteria, thereby treating inflammation and dysbiosis without adverse effects, and can persist for multiple menstrual cycles.
Implementation Method 1
The acidity of a healthy vagina of a woman of child-bearing age (pH about 3.8-4.5) is thought to be due to the degradation of secreted glycogen/glucose to lactic acid and acetate by lactobacilli.
Data Source
AI summary
The invention relates to a pharmaceutical composition for use in treating inflammation in the female genitourinary tract of a human subject, wherein the female subject exhibits a dysbiotic microbiota in the genitourinary tract. The pharmaceutical composition comprises a substantially complete vaginal microbiota preparation, wherein the preparation (i) comprises one, two, three or four bacterial species from the genus Lactobacillus, selected from Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, which comprise about 80-99.9% of all detectable bacterial species of the preparation; and (ii) comprises less than 5% of Gardnerella spp., Atopobium spp., and Prevotella spp.; wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier or diluent. The invention further relates to a method of preparing said composition, and devices comprising and/or using the same.