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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099408
• Other study ID #: 2016PUSZH001
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2017
• Est. completion date: December 30, 2020

Study information

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

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Recurrence
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole Oral
Oral metronidazole 400 mg BID for 7 days at first month.
• "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.

Locations

Country	Name	City	State
China	Dept Obstetrics and Gynecology	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate of BV	Nugent score	4 weeks
Secondary	Recurrence of BV	Nugent score	12 weeks
Secondary	Recurrence of BV	Nugent score	24 weeks