A Prospective, Randomized Controlled Study of Probiotics as Adjuvant Treatment with Metronidazole Vaginal Suppositories for Bacterial Vaginosis

What this Trial Is About

Researchers are evaluating whether taking oral Probiotics called Umeta-mimi for 30 days combined with using Metronidazole vaginal suppositories for 7 days is better at preventing the return of bacterial vaginosis (BV) than using Metronidazole vaginal suppositories alone. This study also aims to understand how vaginal and intestinal bacteria relate by examining samples at several points during and after treatment. The study is a Phase 4, randomized controlled trial focused on women with BV. Participants are divided into two groups: one receives Metronidazole vaginal suppositories (200 mg, two capsules daily for 7 days) alone, and the other receives the same suppositories plus oral Probiotics (Umeta-mimi, 5 billion colony-forming units daily for 30 days). The study collects vaginal and fecal samples at baseline, 14 days after treatment, one month after treatment, and after the third and sixth menstrual cycles following treatment to analyze bacterial changes. During the study, women will attend visits for sample collection and evaluation of bacterial vaginosis status at specified times. Researchers measure the cure rate of BV 14 days after treatment and monitor recurrence up to the sixth menstruation after treatment. The total observation period extends through multiple menstrual cycles to assess long-term effects, with ongoing monitoring of vaginal and fecal microbiota.

A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis