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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03099408

Enrollment

Registered

2017-04-04

Start date

2017-07-01

Completion date

2020-12-30

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis, Recurrence

Keywords

Recurrence, Lactobacillus Vaginal Suppositories

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

Interventions

DRUGMetronidazole Oral

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

DRUGMetronidazole 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

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）

Design outcomes

Primary

Measure	Time frame	Description
Cure rate of BV	4 weeks	Nugent score

Secondary

Measure	Time frame	Description
Recurrence of BV	12 weeks	Nugent score

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026