NCT04771728

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
7mo left

Started Feb 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Feb 2020Dec 2026

Study Start

First participant enrolled

February 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

6.8 years

First QC Date

September 28, 2020

Last Update Submit

June 9, 2025

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Cure rate of BV

    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.

    14 days after treatment

Secondary Outcomes (3)

  • Recurrence of BV

    The first month after treatment

  • Recurrence of BV

    5-7 days after third menstruation after treatment

  • Recurrence of BV

    5-7 days after sixth menstruation after treatment

Study Arms (2)

Metronidazole vaginal

ACTIVE COMPARATOR

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

Drug: Metronidazole vaginal suppositories

Metronidazole vagianl and Probiotics(Umeta-mimi)

EXPERIMENTAL

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

Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)

Interventions

Metronidazole vaginal suppositoriesDRUG

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

Metronidazole vaginal
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）

Also known as: Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）
Metronidazole vagianl and Probiotics(Umeta-mimi)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Shenzhen Hosptal

Shenzhen, Guangdong, 518036, China

RECRUITING

Related Publications (1)

  • Qi F, Fan S, Fang C, Ge L, Lyu J, Huang Z, Zhao S, Zou Y, Huang L, Liu X, Liang Y, Zhang Y, Zhong Y, Zhang H, Xiao L, Zhang X. Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis. Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023.

    PMID: 37575226DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ruifang Wu, M.D.

    Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

    STUDY DIRECTOR

Central Study Contacts

Shangrong Fan, M.D.

CONTACT

86-755-83923333fanshangrong@163.com

Yiheng Liang, M.D.

CONTACT

86-755-8392333313510331823@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Dept of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 28, 2020

First Posted

February 25, 2021

Study Start

February 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)