NCT07305844

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for early_phase_1

Timeline
2mo left

Started Apr 2026

Shorter than P25 for early_phase_1

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

December 12, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 12, 2025

Last Update Submit

April 30, 2026

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Rate of colonization with LBP isolates

    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

Study Arms (1)

Re-challenge

EXPERIMENTAL

Administration of LC106 in clinic, for three days

Drug: LC106

Interventions

LC106DRUG

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

Re-challenge

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

CAPRISA

Vulindlela, South Africa

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Caroline M Mitchell, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Disebo Potloane, MD

    Centre for the AIDS Programme of Research in South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 26, 2025

Study Start

April 28, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Microbial sequences

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
At the time of publication of study results
Access Criteria
THe microbial reads will be posted on a public site, such as the Short Read Archive

Locations

US(1)ZA(1)