Probiotics as Adjuvant Treatment for Bacterial Vaginosis

NCT03894813 | Completed Phase 4 Results

• 1 other identifier: PUshenzhenH2018-016
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Related Clinical Signs or Symptoms at Baseline

  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.

  1 day before starting treatment

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

  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.

  the 30th day after starting treatment

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

  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.

  the 90th day after starting treatment

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

  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.

  the 30th day after starting treatment

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

  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.

  the 90th day after starting treatment

Study Arms (2)

Probiotics and Metronidazole

EXPERIMENTAL

Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days)

Drug: "Probiotics" and "Metronidazole"

Metronidazole vaginal

ACTIVE COMPARATOR

Metronidazole vaginal suppositories(1 suppositories,qd,7 days )

Drug: Metronidazole Vaginal

Interventions

"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)

Also known as: Umeta-Miyue, Lactobacillus rhamnosus GR-1 & Lactobacillus reuteri RC-14 and Metronidazole Suppositories

Probiotics and Metronidazole

Metronidazole Vaginal DRUG

Metronidazole Suppositories,qd, 7 days

Also known as: Metronidazole Suppositories

Metronidazole vaginal

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead
• BGI, China: collaborator

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Probiotics; Metronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prof. Shangrong Fan
• Organization: Peking University Shenzhen Hospital

fanshangrong@163.com

86-0755-83923333

Study Officials

• Ruifang Wu, M.D.

  Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Departmemt of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 29, 2019
• Study Start: March 26, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)