A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Last updated: June 9, 2025
Sponsor: Peking University Shenzhen Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Gynecological Infections

Vaginitis

Sexually Transmitted Diseases (Stds)

Treatment

Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

Metronidazole vaginal suppositories

Clinical Study ID

NCT04771728
PUshenzhenH2020-0310
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study 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

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

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

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
Phase: 4
Study Start date:
February 01, 2020
Estimated Completion Date:
December 01, 2026

Study 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 project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment

Connect with a study center

  • Peking University Shenzhen Hosptal

    Shenzhen, Guangdong 518036
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.