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Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis

StatusRecruiting
PhaseNot applicable
Started
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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.

Record History

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  1. Secondary endpoints: 1 to 6v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06659380
Lead Sponsor Hasanuddin University
Conditions
(from sponsor)		 Bacterial Vaginosis (BV), Menopause
Related terms Vaginosis, Bacterial
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov