Vaginal lIve Biotherapeutic RANdomized Trial

This is a Phase I randomized trial of a novel live biotherapeutic intervention containing multiple strains of L. crispatus. L. crispatus is a species of Lactobacillus commonly found in the human vagina, which is associated with optimal reproductive health outcomes. Detection of, and dominance of the community by, L. crispatus is associated with lower risk for bacterial vaginosis (BV), but no intervention to date has demonstrated the ability to durably shift the vaginal microbiome to L. crispatus dominance in a majority of treated people. In this study, we will compare safety and biologic effects of two formulations of a consortia of L. crispatus strains, and a variety of dosing strategies in women with BV who receive antibiotic treatment. Our primary outcome is colonization with any of the L. crispatus strains contained in the live biotherapeutic product. All participants will have menses suppressed with either injectable progesterone contraception or continuous oral contraceptive pills for the duration of the study. All participants will receive 7 days of oral metronidazole (500mg twice daily) and will be randomized to one of five groups: 1. Placebo daily for 7d after metronidazole treatment 2. LC-106 daily for 7d after metronidazole treatment 3. LC-106 daily for 3d + 4 days of placebo, starting after metronidazole treatment 4. LC-106 daily for 7d, starting on day 3 of metronidazole treatment 5. LC-115 daily for 7d after metronidazole treatment