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NCT Number: NCT03894813

Probiotics as Adjuvant Treatment for Bacterial Vaginosis

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).

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

About this study

Studies have shown that oral probiotics 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-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (30 days) with metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis 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, the first month after treatment, the third month after treatment and the sixth month after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 to 65 years old, with history of sexual activity, premenopausal women；
  • Nugent Score ≥ 7 for diagnosing BV；
  • Sign informed consent.

Exclusion criteria

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

Treatment and study plan

"Probiotics" and "Metronidazole"

Drug

Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)

Other names: Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories

Metronidazole Vaginal

Drug

Metronidazole Suppositories,qd, 7 days

Other names: Metronidazole Suppositories

Primary outcomes

  1. Number of Participants With Related Clinical Signs or Symptoms at Baseline

    Time frame: 1 day before starting treatment

    Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.

  2. Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up

    Time frame: the 30th day after starting treatment

    Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.

  3. Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up

    Time frame: the 90th day after starting treatment

    Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the 30-day follow-up data) were calculated.

  4. Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up

    Time frame: the 30th day after starting treatment

    A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.

  5. Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up

    Time frame: the 90th day after starting treatment

    A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.

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
2019
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2019
Registry last updated
Jul 9, 2021

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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