VIBRANT: A phase 1 randomized trial of multi-strain vaginal L. crispatus live biotherapeutic products in people with bacterial vaginosis - PubMed
6 hours ago
- #live biotherapeutic
- #bacterial vaginosis
- #Lactobacillus crispatus
- VIBRANT is a phase 1 randomized trial evaluating multi-strain vaginal L. crispatus live biotherapeutic products (LBPs) for bacterial vaginosis (BV).
- The trial was conducted in the United States and South Africa, testing LBPs after metronidazole treatment for BV.
- Participants received either a placebo or 3 or 7 days of active LBPs.
- LBP strains were detected in 66.1% of participants in the active arms within the first 5 weeks.
- Nearly half (49%) of those colonized remained so at 12 weeks despite the short treatment course.
- Participants were most often colonized by one of three component strains, with no geographic differences observed.
- LBPs were found to be safe, acceptable, and well tolerated, with no serious adverse events reported.
- The results support the development of interventions to optimize the vaginal microbiome.
- Conflict of interest disclosures include financial interests and patents related to the LBPs tested.