Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis
Abstract
Bacterial vaginosis (BV) affects 15–50% of women of reproductive age, with high recurrence rates after antibiotic treatment. This randomized, double-blind, placebo controlled phase 2b trial evaluated the efficacy of Lactobacillus crispatus CTV-05 (Lactin-V) in preventing BV recurrence. Participants (N=228) were assigned to receive Lactin V or placebo for 11 weeks following metronidazole treatment. By week 12, BV recurrence occurred in 30% of the Lactin V group versus 45% in the placebo group (risk ratio 0.66; 95% CI, 0.44–0.87; P=0.01). L. crispatus CTV-05 was detected in 79% of Lactin V recipients at week 12. Adverse events were similar between groups. The study concluded that Lactin V significantly reduces BV recurrence post antibiotic therapy.