Status:
RECRUITING
A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Lead Sponsor:
Peking University Shenzhen Hospital
Collaborating Sponsors:
BGI, China
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
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...
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 proje...
Eligibility Criteria
Inclusion
- Aged 18 to 55 years old, with history of sexual activity,
- Amsel criterion for diagnosing BV
- Sign informed consent
Exclusion
- History of systemic organic diseases or psychiatric diseases
- Planning for or during pregnancy, lactation, menstruation
- within 5 days of onset of the disease, any antibiotics has been used
- Long-term use of contraceptives or immunosuppressant
- Anaphylactic constitution or allergic to known ingredients of research drugs
- No same fixed partner (RSP) before and after treatment
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04771728
Start Date
February 1 2020
End Date
December 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, China, 518036