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

Peking University

Status and phase: Completed; Phase 4

Conditions: Bacterial Vaginosis; Recurrence

Treatments: Drug: "Metronidazole" and "Lactobacillus"; Drug: Metronidazole Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT03099408

2016PUSZH001

Details and patient eligibility

About

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

Full 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

Enrollment: 66 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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）

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Metronidazole Oral

Active Comparator group

Description:

Metronidazole Oral

Treatment:

Drug: Metronidazole Oral

"Metronidazole" and "Lactobacillus"

Active Comparator group

Description:

"Metronidazole" and "Lactobacillus"

Treatment:

Drug: "Metronidazole" and "Lactobacillus"