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

Phase 4

Completed

• Conditions: Bacterial Vaginosis; Recurrence
• Interventions: Drug: "Metronidazole" and "Lactobacillus"; Drug: Metronidazole Oral

• Registration Number: NCT03099408
• Lead Sponsor: Peking University Shenzhen Hospital

Brief 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

Study Timeline

• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-04
• Study Start: 2017-07-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• Women be at least 18 years of age
• Have symptoms of vaginal odor and or/discharge
• Meet the clinical (Amsel) criteria for BV
• Willing to participate in research

Exclusion Criteria

• Presence of another vaginal infection or STD
• Allergy to metronidazole
• Pregnant or nursing
• Use of oral or intravaginal antibiotics within the past 2 weeks
• HIV or other chronic disease
• Inability to keep return appointments
• Contraindications for Lactobacillus Vaginal Suppositories（those without sexual history）

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Metronidazole" and "Lactobacillus"	"Metronidazole" and "Lactobacillus"	"Metronidazole" and "Lactobacillus"
Metronidazole Oral	Metronidazole Oral	Metronidazole Oral

Primary Outcome Measures

Name	Time	Method
Cure rate of BV	4 weeks	Nugent score

Secondary Outcome Measures

Name	Time	Method
Recurrence of BV	24 weeks	Nugent score

Trial Locations

Locations (1)

Dept Obstetrics and Gynecology; 🇨🇳 Shenzhen, Guangdong, China