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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | Peking University Shenzhen Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Status | Recruiting |
| Started | February 1, 2020 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT04771728 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
- Study coordinator: Shangrong Fan, M.D.
- Email: fanshangrong@163.com
- Phone: 86-755-83923333
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if the bacteria in the genital area of men can affect how often their female partners get bacterial vaginosis and whether cleaning with a certain solution can help reduce this risk.
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This study is testing if the contraceptive Phexxi can improve vaginal health by increasing good bacteria and reducing discomfort for women.
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Lactoferrin as an alternative to antibiotics for BV or yeast infections in women
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.