NCT03099408

Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

A Pilot Study of Efficacy and Safety of Oral Metronidazole Versus Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent the Recurrence of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

We are trying to determine if Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Detailed description

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Based on currently national guidelines by using oral metronidazole 400 BID for 7 days, a high recurrence rate of BV were reported. We hypothesize that the Oral Metronidazole with Lactobacillus Vaginal Suppositories is better than Oral Metronidazole in Preventing the Recurrence of Bacterial Vaginosis

Conditions

• Bacterial Vaginosis
• Recurrence

Interventions

Type	Name	Description
DRUG	Metronidazole Oral	Oral metronidazole 400 mg BID for 7 days at first month.
DRUG	"Metronidazole" and "Lactobacillus"	Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2017-04-04
• Last updated: 2021-02-01

Locations

1 site across 1 country: China