Using probiotics with antibiotics to prevent bacterial vaginosis recurrence
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
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 |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Peking University Shenzhen Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT04771728 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 55 with a history of sexual activity and diagnosed with bacterial vaginosis.
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.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of bacterial vaginosis in patients.
How similar studies have performed: Previous studies have indicated that probiotics can positively influence vaginal flora, suggesting potential success for this combined treatment approach.
Eligibility criteria
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 this trial is running
Shenzhen, Guangdong
- Peking University Shenzhen Hosptal — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shangrong Fan, M.D.
- Email: fanshangrong@163.com
- Phone: 86-755-83923333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.