Lactobacillus Crispatus Vaginal Composition Without Antibiotic Pretreatment

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Solution Overview

Problem

Existing therapies for preventing pregnancy complications such as miscarriage and preterm birth, particularly in high-risk populations, are ineffective and often require antibiotic pretreatment, which is contraindicated for pregnant women.

Innovation Solution

A composition comprising Lactobacillus crispatus cells, expressing a pullulanase gene and producing L- and D-lactic acid, is topically applied to the vagina without prior antibiotic treatment, promoting a protective vaginal microbiota to increase the probability of full-term birth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antibiotic pretreatment is used to reduce competition before administering live Lactobacillus therapeutics, then colonization effectiveness is improved, but safety and suitability for pregnant women deteriorates due to contraindications

Engineering Contradiction:
Improvecolonization effectivenessVSAvoidsafety contraindication
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The Lactobacillus crispatus strain performs self-aggregation and self-adhesion to vaginal epithelial cells without requiring antibiotic-mediated competition reduction. The bacteria naturally bind to host cells through surface proteins, enabling direct colonization without harmful pretreatment interventions.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention performs preliminary aggregation of Lactobacillus cells into clumps before administration, enhancing their collective ability to adhere to vaginal epithelium. This pre-formed aggregate structure facilitates more effective colonization without requiring antibiotic pretreatment to reduce competing bacteria.

Inventive Principle:
Principle #10Preliminary action

2Object-affected harmful factors

If conventional Lactobacillus products are used in isolation without antibiotic pretreatment, then safety for pregnant women is improved, but colonization and therapeutic benefit deteriorates

Engineering Contradiction:
ImprovesafetyVSAvoidcolonization effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention merges multiple functional characteristics into a single Lactobacillus crispatus strain: self-aggregation, self-adhesion to vaginal epithelium, production of antimicrobial substances, and acidification capability. This multi-functional strain achieves effective colonization and therapeutic benefit without requiring antibiotic pretreatment, resolving the contradiction between safety and effectiveness.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If antibiotics are used to treat bacterial vaginosis in pregnant women, then infection treatment is improved, but fetal safety and microbiome restoration deteriorates

Engineering Contradiction:
Improveinfection treatmentVSAvoidfetal safety
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The Lactobacillus crispatus strain provides self-service protection against bacterial vaginosis through its inherent ability to aggregate, adhere to epithelial cells, and produce antimicrobial substances. This natural protective mechanism eliminates the need for antibiotic treatment, thereby treating the underlying issue without compromising fetal safety or disrupting the microbiome.

Inventive Principle:
Principle #25Self-service

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 Lactobacillus crispatus composition significantly reduces preterm birth rates and miscarriage risks in high-risk pregnant women by establishing a dominant vaginal microbiota, enhancing vaginal health without the need for antibiotics.

Implementation Method 1

Lactobacillus crispatus cells functionally express a pullulanase gene to utilize glycogen and produce both L- and D-lactic acid

Methodology Applied
Scientific EffectFermentation: Fermentation

Implementation Method 2

Vaginal Lactobacilli are thought to play an important role in resistance to infection via production of lactic acid and acidification of the vagina or by production of other antimicrobial products, such as hydrogen peroxide H2O2

Methodology Applied
Scientific EffectHydrogen peroxide production: Hydrogen Peroxide

Data Source

PatentUS20250345375A1Lactobacillus crispatus composition for use in pregnant subjects
Publication Date: 2025.11.13 IMPERIAL COLLEGE INNVOATIONS LTD
  • US20250345375A1 patent drawing
  • US20250345375A1 patent drawing
  • US20250345375A1 patent drawing

AI summary

The present invention relates to a composition for use in pregnant subjects comprising Lactobacillus crispatus cells, wherein said composition minimises and/or prevents pregnancy complications, such as miscarriage, preterm labour and preterm birth.