NCT03894813

Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
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)
DRUG	Metronidazole Vaginal	Metronidazole Suppositories,qd, 7 days

Timeline

• Start date: 2019-03-26
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-03-29
• Last updated: 2021-07-09
• Results posted: 2021-07-09

Locations

1 site across 1 country: China