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

NCT ID: NCT03099408

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-12-30

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

Conditions

Bacterial Vaginosis; Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metronidazole Oral

Metronidazole Oral

Group Type: ACTIVE_COMPARATOR

Metronidazole Oral

Intervention Type: DRUG

Oral metronidazole 400 mg BID for 7 days at first month.

"Metronidazole" and "Lactobacillus"

"Metronidazole" and "Lactobacillus"

Group Type: ACTIVE_COMPARATOR

"Metronidazole" and "Lactobacillus"

Intervention Type: DRUG

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.

Interventions

Metronidazole Oral

Oral metronidazole 400 mg BID for 7 days at first month.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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）

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Shenzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shangrong Fan

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shangrong Fan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospital

Salvatore Giovanni Vitale, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Human Pathology in Adulthood and Childhood, University of Messina (Italy)

Locations

Dept Obstetrics and Gynecology

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

2016PUSZH001

Identifier Type: -

Identifier Source: org_study_id