Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894813
• Other study ID #: PUshenzhenH2018-016
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2021
• Source: Peking University Shenzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 65 years old, with history of sexual activity, premenopausal women;

2. Nugent Score = 7 for diagnosing BV;

3. Sign informed consent.

Exclusion Criteria:

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

2. History of systemic organic diseases or psychiatric diseases;

3. Planning for or during pregnancy, lactation, menstruation;

4. within 5 days of onset of the disease, any antibiotics has been used;

5. Long-term use of contraceptives or immunosuppressant;

6. Anaphylactic constitution or allergic to known ingredients of research drugs.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• "Probiotics" and "Metronidazole"
Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
• Metronidazole Vaginal
Metronidazole Suppositories,qd, 7 days

Locations

Country	Name	City	State
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital	BGI, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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