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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborators:
Bill and Melinda Gates Foundation Centre for the AIDS Programme of Research in South Africa Ragon Institute of MGH, MIT and Harvard