Impact of Clinician-administered Vaginal Live Biotherapeutic Product

NCT07305844 — Early Phase 1, Completed, 26 participants, Caroline Mitchell

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

Registry	NCT07305844
Status	Completed
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	26 (Actual)
Sponsor	Caroline Mitchell (Other)
Conditions	Bacterial Vaginosis
Interventions	LC106 (Drug)
Dates	start 2026-04-28, primary completion 2026-08-13, completion 2026-08-13, first posted 2025-12-26, last updated 2026-09-29
Locations	2 sites in United States, South Africa

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Re-challenge	Experimental	Drug: LC106	Administration of LC106 in clinic, for three days

LC106 (Drug): This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

+Outcome measures

Primary outcomes

Rate of colonization with LBP isolates [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.

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

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

+Locations (2)

Facility	City	Country	Status
Massachusetts General Hospital	Boston, Massachusetts	United States
CAPRISA	Vulindlela	South Africa

+Investigators

Caroline M Mitchell, MD, MPH, Principal investigator, Massachusetts General Hospital
Disebo Potloane, MD, Principal investigator, Centre for the AIDS Programme of Research in South Africa