Clinical Trial

Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

Recruiting
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Record status
This record was last updated October 28, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
This study is a double-blind, randomized, controlled trial (RCT) aimed at evaluating the effects of Lactobacillus sp. probiotic administration on the vaginal microbiota changes in postmenopausal women with bacterial vaginosis and how its affect to immunology profile. Postmenopausal women diagnosed with bacterial vaginosis will be recruited as subjects as long as collected period in this study. All patients will receive Metronidazole antibiotic treatment then blind-randomly be divided into two groups: the treatment group, receiving Floragyn® probiotic tablets (Lapi, Indonesia), and the placebo group, receiving Cal 95® (Lapi, Indonesia). As a control, postmenopausal women without bacterial vaginosis will also be included and receive Floragyn® probiotic tablets only.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-24.
Trial Details
NCT Number NCT06659380
Lead Sponsor Hasanuddin University
Conditions Bacterial Vaginosis (BV), Menopause
Enrollment 12 participants
Start Date 2024-06-26
Primary Completion 2024-12-31 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-28