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Probiotics as an Adjunct to Antibiotics for Recurrent Bacterial Vaginosis
Sponsor: Nishtar Medical University
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
Conditions
Interventions
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.
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