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Completed
NCT07305844
Impact of Clinician-administered Vaginal Live Biotherapeutic Product
Conditions: Bacterial Vaginosis
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 26
Sponsor: Caroline Mitchell
Location: Massachusetts General Hospital Boston Massachusetts
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07305844). StuddyBuddy aggregates publicly available trial information.
