The use of Lactin-V after treatment with vaginal metronidazole significantly reduces the recurrence incidence of bacterial vaginosis, according to a study in the New England Journal of Medicine.
The randomised, double-blind, placebo-controlled Phase IIb trial recruited women who had received a diagnosis of bacterial vaginosis and a five-day course of 0.75% metronidazole gel, within 30 days of screening. Women between the ages of 18 and 45 years, received vaginally administered Lactobacillus crispatus CTV-05 (Lactin-V)(N=152) or placebo (N=76) for 11 weeks and followed up for 24 weeks.
The primary outcome, recurrence of bacterial vaginosis by week 12, occurred in 46 participants (30%) in the treatment group and 34 participants (45%) in the placebo group, risk ratio 0.66 (95% CI 0.44-0.87; P=.01) and 0.73 (95% CI 0.54-0.92) at 24 weeks.
In the treatment group, L. crispatus CTV-05 was detected in 79 to 84 per cent at weeks 4, 8 and 12, and 48 per cent of participants at week 24. In the placebo group, L. crispatus CTV-05 was detected in 2-6 per cent of participants at weeks 4, 8 and 12, and in 2 per cent of participants at week 24.
Treatment-related adverse events did not differ between groups.