Abstract
BV affects 15%–50% of women, frequently recurs after antibiotic treatment and is associated with an increased risk of acquiring sexually transmitted infections including HIV, and preterm birth. We recently completed a Phase 2B placebo-controlled trial of LACTIN-V (formulated vaginal Lactobacillus crispatus CTV-05) dosed over 11 weeks that demonstrated efficacy in the prevention of recurrent BV following use of vaginal metronidazole. In the intervention arm, 79% of participants were colonized with L. crispatus CTV-05 following the 11-week dosing phase. In this sub-study, we used metagenomic Next Generation Sequencing (mNGS) to analyze samples collected during this trial in order to investigate changes in the vaginal microbiome following treatment.
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