Probiotics as Adjuvant Treatment for Bacterial Vaginosis

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators are trying to determine if oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days)with metronidazole vaginal suppositories(7 days) is better than using metronidazole vaginal suppositories only in preventing the recurrence of bacterial vaginosis (BV).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Shenzhen Hospital
• Collaborator: BGI, China
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women；

2. Nugent Score ≥ 7 for diagnosing BV；

3. Sign informed consent.

Exclusion Criteria:

1. mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;

2. History of systemic organic diseases or psychiatric diseases;

3. Planning for or during pregnancy, lactation, menstruation;

4. within 5 days of onset of the disease, any antibiotics has been used;

5. Long-term use of contraceptives or immunosuppressant;

6. Anaphylactic constitution or allergic to known ingredients of research drugs.