Impact of Clinician-administered Vaginal Live Biotherapeutic Product

Enrolling by invitation · Early Phase 1

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT07305844

Run by

Caroline Mitchell

People needed

71

Starts

2026-04-28

Expected to finish

2026-06-30

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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