Effects of Lactobacillus Probiotic on Vaginal Health and Immunity in Postmenopausal Women with Bacterial Vaginosis

What this Trial Is About

Researchers are evaluating the effects of Lactobacillus sp. probiotics on vaginal bacteria and immune responses in postmenopausal women diagnosed with bacterial vaginosis. This study is a double-blind, randomized controlled trial aiming to understand how probiotic therapy may influence the vaginal microbiota changes and immunological profiles in this population. The research also includes a control group of postmenopausal women without bacterial vaginosis receiving probiotics to compare results. Participants diagnosed with bacterial vaginosis will first receive metronidazole antibiotic treatment either orally or intravaginally for five days. After 48 hours, they will be randomly assigned to receive daily oral doses of either Floragyn4 probiotic tablets containing Lactobacillus strains or placebo tablets Cal954 for two weeks. The control group without bacterial vaginosis will receive Floragyn4 probiotic tablets only for the same two-week period. Throughout the study, vaginal swabs and blood samples will be collected before treatment, at the end of probiotic or placebo administration, and four weeks after the last dose. These samples will be analyzed for vaginal pH, glucose, protein levels, microbiome composition, and blood markers including interleukin 6 and 10, as well as leukocyte counts. The primary outcome is bacterial vaginosis status over seven weeks, with secondary outcomes measuring immune and inflammatory markers. The study participation extends over approximately seven weeks with close monitoring of microbiota and immune changes.

Probiotic Efficacy in Postmenopausal Women with Bacterial Vaginosis