Biotherapeutic Lactin-V reduces incidence of bacterial vaginosis recurrence

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

Relevant Reading: Vaginal Colonization by Probiotic Lactobacillus crispatus CTV-05 Is Decreased by Sexual Activity and Endogenous Lactobacilli

In-Depth [randomized controlled trial]: This randomized control trial enrolled 228 patients in a multicenter study from four sites in five countries in the United States of America. The inclusion criteria included pubertal adolescents (12 to <18 years of age). Inclusion criteria included: premenopausal women between 18 to 45 years of age; met at least three Amsel criteria and had a Nugent score of 4 to 10 for the diagnosis of bacterial vaginosis; and negative results on STI tests. The exclusion criteria for the study included postmenopausal women over 45 years of age and participants with poor adherence to treatment. The patients were randomized to the Lactin-V or placebo treatment group in a 2:1 ratio. The treatment in the study began after a five-day course of vaginal metronidazole. The primary outcome was the percentage of participants who had recurrent bacterial vaginosis at any follow-up visit including the week 12 visit. Bacterial vaginosis recurrence was defined by the presence of at least three Amsel criteria and a Nugent score of 4 to 10. Additionally, adverse outcomes within both treatment groups were recorded. At week 12, the recurrence of bacterial vaginosis occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio, 0.66, 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). Furthermore, among the participants without bacterial vaginosis recurrence at week 12, recurrence of bacterial vaginosis was present in 13 out of 106 participants (12%) in the Lactin-V and 7 of 42 participants (17%) in the placebo group (risk ratio, 0.73, 95% CI, 0.54 to 0.92) at week 24. Abnormal vaginal discharge, abnormal vaginal odor and vaginal itching were the most common local adverse effects in both groups. Abdominal pain, headache, and frequent urination were the most frequent systemic adverse effects in both groups. Taken together, administration of Lactin-V after a five-day course of vaginal metronidazole significantly reduced the recurrence of bacterial vaginosis in patients.

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