Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 55 Women only

Using probiotics with antibiotics to prevent bacterial vaginosis recurrence

Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

Run by Peking University Shenzhen Hospital · NCT04771728 · Data updated 2026-11-12

This study is testing if taking probiotics with antibiotics can help prevent bacterial vaginosis from coming back.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 55 Years
SexWomen only
Enrollment140 (estimated)
SponsorPeking University Shenzhen Hospital
Academic / other
Locations1 site (Shenzhen, Guangdong)
StatusRecruiting
StartedFebruary 1, 2020
Main results expectedDecember 1, 2026
Study endsDecember 1, 2026
Registry record updatedJune 12, 2025
Trial IDNCT04771728 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 18 to 55 with a history of sexual activity and diagnosed with bacterial vaginosis.

Probably not a fit

Patients with systemic diseases, those who are pregnant or lactating, or individuals with recent antibiotic use may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of combining oral probiotics (Umeta-mimi) with Metronidazole vaginal suppositories in preventing the recurrence of bacterial vaginosis (BV). Participants will receive the probiotics for 30 days alongside a 7-day course of Metronidazole. The study will also analyze the relationship between vaginal and intestinal microbiota through metagenomic assessments at various time points. The goal is to determine if this combined treatment is superior to using Metronidazole alone.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of bacterial vaginosis in patients.

How similar studies have gone: Previous studies have indicated that probiotics can positively influence vaginal flora, suggesting potential success for this combined treatment approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Aged 18 to 55 years old, with history of sexual activity,
2. Amsel criterion for diagnosing BV
3. Sign informed consent

Exclusion Criteria:

1. History of systemic organic diseases or psychiatric diseases
2. Planning for or during pregnancy, lactation, menstruation
3. within 5 days of onset of the disease, any antibiotics has been used
4. Long-term use of contraceptives or immunosuppressant
5. Anaphylactic constitution or allergic to known ingredients of research drugs
6. No same fixed partner (RSP) before and after treatment

Where it's running

  • Peking University Shenzhen Hosptal
    Shenzhen, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.