Microbiota effects and predictors of Lactobacillus crispatus colonization after treatment with a vaginal live biotherapeutic: results from a randomized, double-blinded, placebo-controlled trial
Bloom, S. M.; Symul, L.; Elsherbini, J.; Xu, J.; Hussain, S.; Shih, J.; Sango, A.; Mitchell, C. M.; Hemmerling, A.; Parks, T. P.; Kannan, A.; Hussain, F. A.; Cohen, C. R.; Holmes, S. P.; Kwon, D. S.
10.1101/2025.08.18.25333897 medRxivShow 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 colonization was associated with pre-MTZ microbiota, baseline cytokine profiles, post-MTZ bacterial load, and clinical and behavioral variables. These findings elucidate LBP microbiota effects and identify predictors of treatment success, informing improved intervention strategies to advance womens health.
Matching journals
The top 8 journals account for 50% of the predicted probability mass.
Similar papers in this journal
- The gut microbiome and early-life growth in a population with high prevalence of stunting 94%
- Microdiversity of the Vaginal Microbiome is Associated with Preterm Birth 94%
- Impact of early life antibiotic and probiotic treatment on gut microbiome and resistome of very-low-birth-weight preterm infants 94%
Similar papers in this journal
- Lactobacillus iners dominates the vaginal microbiota of healthy Italian women of reproductive age. 95%
- Strain-level analysis of Bifidobacterium spp. from gut microbiomes of adults of differing lactase persistence genotypes 94%
- Longitudinal profiling of the macaque vaginal microbiome reveals similarities to diverse human vaginal communities: implications for use as a pre-clinical model for bacterial vaginosis 94%
Similar papers in this journal
- Microbiota supplementation with Bifidobacterium and Lactobacillus modifies the preterm infant gut microbiota and metabolome 94%
- Intraspecies strain exclusion, antibiotic pretreatment, and donor selection control microbiota engraftment after fecal transplantation 93%
- The clinical drug candidate ebselen attenuates inflammation and promotes microbiome recovery after antibiotic treatment for Clostridium difficile infection 93%
Similar papers in this journal
"Similar papers" are the closest papers from that journal in the model's embedding space. They show what the match is built on, but the ranking comes mostly from a classifier over the whole training set, not from these examples alone.