Impact of Clinician-administered Vaginal Live Biotherapeutic Product

April 30, 2026 updated by: Caroline Mitchell

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Vulindlela, South Africa
        • CAPRISA
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Re-challenge
Administration of LC106 in clinic, for three days
Drug: LC106
This is a 6-strain L. crispatus vaginal live biotherapeutic tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caroline Mitchell

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMRC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Microbial sequences

IPD Sharing Time Frame

At the time of publication of study results

IPD Sharing Access Criteria

THe microbial reads will be posted on a public site, such as the Short Read Archive

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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