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

Sponsor
Peking University Shenzhen Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04771728
Collaborator
BGI, China (Other)
140
Enrollment
1
Location
2
Arms
28.9
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Metronidazole vaginal suppositories
  • Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
 Phase 4

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 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Metronidazole vaginal

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

Drug: Metronidazole vaginal suppositories
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Experimental: Metronidazole vagianl and Probiotics(Umeta-mimi)

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)
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）

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cure rate of BV [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 Outcome Measures

    1. Recurrence of BV [The first month after treatment]

      Nugent score

    2. Recurrence of BV [5-7 days after third menstruation after treatment]

      Nugent score

    3. Recurrence of BV [5-7 days after sixth menstruation after treatment]

      Nugent score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Shenzhen Hosptal Shenzhen Guangdong China 518036

    Sponsors and Collaborators

    • Peking University Shenzhen Hospital
    • BGI, China

    Investigators

    • Study Director: Ruifang Wu, M.D., Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shangrong Fan, Professor of Dept of Obstetrics and Gynecology, Peking University Shenzhen Hospital
    ClinicalTrials.gov Identifier:
    NCT04771728
    Other Study ID Numbers:
    • PUshenzhenH2020-0310
    First Posted:
    Feb 25, 2021
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Vaginal Diseases
    Metronidazole

    Study Results

    No Results Posted as of Sep 20, 2021