MedTrace Logo

Impact of Clinician-administered Vaginal Live Biotherapeutic Product

NCT07305844 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

LC106

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

Sponsors & Collaborators

  • Caroline Mitchell

    lead OTHER

Principal Investigators

  • Caroline M Mitchell, MD, MPH · Massachusetts General Hospital

  • Disebo Potloane, MD · Centre for the AIDS Programme of Research in South Africa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305844 on ClinicalTrials.gov