Microbiota effects and predictors of <i>Lactobacillus crispatu</i>s colonization after treatment with a vaginal live biotherapeutic: results from a randomized, double-blinded, placebo-controlled trial.

ABSTRACT: Bacterial vaginosis (BV) affects >25% of women worldwide and often recurs after standard-of-care metronidazole (MTZ) treatment. LACTIN-V, a live biotherapeutic product (LBP) containing Lactobacillus crispatus strain CTV-05, reduced recurrent BV in a Phase 2b clinical trial, but efficacy was incomplete. We characterized microbiota and immune effects and correlates of treatment success in trial samples. By week 12, L. crispatus-dominant microbiota was achieved in 30% of LBP recipients compared to 9% of placebo (benefit ratio: 3.31; p<0.005). This effect was mostly due to CTV-05, but native L. crispatus strains were also present and increased over time. Inflammatory cytokines decreased in both arms after MTZ, but returned to baseline in placebo recipients. L. crispatus

SUBMITTER: Bloom SM 

PROVIDER: S-EPMC12393677 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature