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NCT Number: NCT04771728

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, 518036, China

Location status: Recruiting

Location contact

Yiheng Liang, M.D.

CONTACT

[email protected]

8675583923333 ext. 5505

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 55 years old, with history of sexual activity,
  • Amsel criterion for diagnosing BV
  • Sign informed consent

Exclusion criteria

  • 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

Treatment and study plan

Metronidazole vaginal suppositories

Drug

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )

Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

Drug

Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days)

Other names: Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi)

Primary outcomes

  1. Cure rate of BV

    Time frame: 14 days after treatment

    Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell.

Secondary outcomes

  1. Recurrence of BV

    Time frame: The first month after treatment

    Nugent score

  2. Recurrence of BV

    Time frame: 5-7 days after third menstruation after treatment

    Nugent score

  3. Recurrence of BV

    Time frame: 5-7 days after sixth menstruation after treatment

    Nugent score

Study contacts

Contact information is provided by the study sponsor or research team.

Shangrong Fan, M.D.

CONTACT

[email protected]

86-755-83923333 ext. 5505

Yiheng Liang, M.D.

CONTACT

[email protected]

86-755-83923333 ext. 5505

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Collaborators

  • BGI, China

Registry information

Official study title

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2021
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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