NCT04771728 A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis
| NCT ID | NCT04771728 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University Shenzhen Hospital |
| Condition | Bacterial Vaginosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2020-02-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Ruifang Wu, M.D.
STUDY DIRECTOR
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
Frequently Asked Questions
Who can join the NCT04771728 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Bacterial Vaginosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04771728 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04771728 currently recruiting?
Yes, NCT04771728 is actively recruiting participants. Contact the research team at fanshangrong@163.com for enrollment information.
Where is the NCT04771728 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT04771728 clinical trial?
NCT04771728 is sponsored by Peking University Shenzhen Hospital. The principal investigator is Ruifang Wu, M.D. at Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital. The trial plans to enroll 140 participants.