NCT04771728

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

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis

Detailed description

Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Metronidazole vaginal suppositories	Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
DRUG	Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)	Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）

Timeline

• Start date: 2020-02-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-02-25
• Last updated: 2025-06-12

Locations

1 site across 1 country: China