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Vaginal lIve Biotherapeutic RANdomized Trial (VIBRANT)
The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question\[s\] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo. Participants will: * be treated with oral antibiotics for BV * receive 7 days of vaginal study product * collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment. Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Feb 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Bacterial Vaginosis
Interventions
- LC106
- LC115
- Placebo
- Metronidazole Oral
Countries
South Africa, United States