#VisualAbstract: Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

1. Lactin-V treatment after the use of vaginal metronidazole was shown to significantly lower the incidence of bacterial vaginosis recurrence.

2. Adverse effect included abnormal vaginal discharge, abnormal vaginal odor, and genital itching.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Bacterial vaginosis affects women of reproductive age worldwide and is associated with increased risk of sexually transmitted infections (STIs) and premature birth. Furthermore, bacterial vaginosis causes negative emotional and social effects, as well as a substantial economic burden on the health care system. Current antibiotic agents result in the recurrence of bacterial vaginosis within three months. Lactobacillus cripastus CTV-05 (Lactin-V) was developed as a live biotherapeutic product containing the naturally occurring vaginal strain of L. crispatus. As such, this study assessed the ability of Lactin-V treatment for bacterial vaginosis to lower the incidence of bacterial vaginosis recurrence. The participants were randomized to receive Lactin-V or placebo treatment for 11 weeks. The study determined the patients in the Lactin-V group had a significantly lower incidence of bacterial vaginosis recurrence compared to the patients in the placebo group. However, patients in the treatment group did experience local adverse effects ranging from abnormal vaginal discharge to vaginal itching. This randomized, double-blind, trial was limited by the short follow-up period, which did not allow for the longitudinal measurement of treatment effects over a six to twelve-month time period. Data collection at longer follow-up periods would enable the assessment of long-term L. crispatus colonization sustainability and prevention of bacterial vaginosis. Another limitation of the study was patients administered the treatment doses themselves resulting in a variation of treatment application. Nonetheless, this study was strengthened by high treatment adherence rate and similar rates of treatment discontinuation in both groups. For physicians, these findings highlighted an alternative therapy to be prescribed to patients suffering from recurrent bacterial vaginosis.

Click to read the study in NEJM

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