By InvitationEarly Phase 1

Impact of Clinician-administered Vaginal Live Biotherapeutic Product

United States, South Africa71 participantsStarted 2026-04-28

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of colonization with LBP isolates

Timeframe: 5 weeks

Trial details

NCT IDNCT07305844

SponsorCaroline Mitchell

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

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