Impact of Clinician-administered Vaginal Live Biotherapeutic Product

This is an open-label, single-arm, Phase Ib trial assessing the consistency of response and colonization kinetics of a vaginally inserted live biotherapeutic intervention with optimized adherence.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

CAPRISA, Vulindlela, South Africa

About this study

In this study investigators will enroll participants from the VIBRANT study who received active study product and test the vaginal microbiome. If a participant does not have a Lactobacillus predominant vaginal microbiome, they will re-dose with LC106 in the clinic for three days in a row. This will allow understanding of how consistent the response to LC106 is, and whether directly monitored administration improves results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Previous participant in the VIBRANT study, randomized to active LBP
Nugent score 4-10

Exclusion criteria

Infection requiring antibiotics detected on screening labs
Use of oral or vaginal antibiotics in the 30 days prior to screening
Use of an oral or vaginal probiotic in the 30 days prior to screening

Treatment and study plan

LC106

Drug

This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

Primary outcomes

Rate of colonization with LBP isolates

Time frame: 5 weeks

Detection of at least one isolate from the LBP with at least 5% relative abundance by metagenomics, or a combination of isolates at 10% or higher.

Sponsors and collaborators

Lead sponsor

Caroline Mitchell

Other

Registry information

Official study title

Open-label, Single-arm Study to Assess the Colonization Kinetics of Clinician- Administered Vaginal Live Biotherapeutic Product Containing Multiple Strains of Lactobacillus Crispatus.

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Dec 26, 2025
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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