Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07893782
PHASE4

Probiotics as an Adjunct to Antibiotics for Recurrent Bacterial Vaginosis

Sponsor: Nishtar Medical University

View on ClinicalTrials.gov

Summary

This randomized clinical trial aims to compare the recurrence of bacterial vaginosis (BV) in women receiving probiotics alongside antibiotic treatment versus women receiving antibiotic treatment alone. Bacterial vaginosis is a common vaginal condition that can recur after successful treatment. The main question this study aims to answer is: \- Does adding probiotics to standard antibiotic treatment reduce the recurrence of bacterial vaginosis compared with antibiotic treatment alone? The study will include 70 non-pregnant women aged 20-45 years diagnosed with recurrent bacterial vaginosis. All participants will initially receive metronidazole to treat the current episode. After successful treatment is confirmed, participants will be randomly assigned to one of two groups: * Group A: Probiotic capsules containing Lactobacillus plantarum, Lactobacillus rhamnosus, and Bifidobacterium animalis subsp. lactis, followed by monthly maintenance dosing for four months. * Group B: Placebo capsules, followed by the same monthly maintenance schedule. Participants will undergo monthly vaginal examinations for four months to assess whether bacterial vaginosis recurs. Recurrence will be diagnosed using Amsel's criteria, which include assessment of vaginal discharge, vaginal pH, clue cells on microscopy, and a characteristic fishy odor test. The researchers will compare the frequency of bacterial vaginosis recurrence between the two groups to determine whether adjunctive probiotic treatment reduces recurrence.

Official title: Efficacy of Probiotic Adjunctive to Antibiotic in Women With Recurrent Bacterial Vaginosis

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-08-01

Completion Date

2026-01-31

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic Combination Cap/Tab

Participants will receive one probiotic capsule (Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020, and Bifidobacterium animalis subsp. lactis BL050) daily for 14 days after successful treatment of bacterial vaginosis. Subsequently, one capsule daily will be taken for 7 days each month, starting on the first day of menstruation, for 4 months.

DRUG

Placebo capsules

Participants will receive placebo capsules matching the probiotic capsules in appearance and dosing schedule. One capsule will be taken daily for 14 days after successful treatment of bacterial vaginosis. Followed by one capsule daily for 7 days each month, starting on the first day of menstruation, for 4 months.

Locations (1)

Nishtar Medical University

Multan, Punjab Province, Pakistan