Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study.

objectiveTo investigate the clinical effects of a 10-strain probiotic on parameters of vaginal health in a pilot, open label study in women with intermediate Nugent score (NS) or vaginal pH >4.5. METHODOLOGY: A total of 43 healthy premenopausal women, ages 18 to 50 years, with NS of 4-6 or vaginal pH >4.5 were enrolled. Participants consumed a probiotic formulation (Feminine Support™), containing 8 lactobacilli and 2 bifidobacteria strains, with a daily dose of 2.5×10

resultsA total of 36 participants were included in the analysis set, with 24 and 12 participants included in subgroups 1 and 2, respectively. In the analysis set, there was a significant reduction in vaginal pH, from baseline, at day 28 (mean change=-0.19, P = 0.047). Participants in subgroup 1 achieved a significant reduction in vaginal pH from baseline, at day 28 (mean change=-0.23, P = 0.029) and day 42 (mean change=-0.29, P = 0.008), while participants in subgroup 2 achieved a significant and quantitatively greater reduction in vaginal pH from baseline to day 42 (mean change=-0.64, P = 0.008). No significant changes in NS were reported, due in part to highly diverse baseline levels. Vaginal microbial abundance exhibited a majority lactobacilli abundance at baseline, which was maintained over the study period. Vaginal pH was inversely associated with lactobacilli abundance throughout the study (P < 0.005). The product was well tolerated with high compliance. Two participants reported adverse events with suspected causality, which were mild and resolved during the study.

conclusionThis 10-strain probiotic formulation was well tolerated and helped reduce vaginal pH in women with intermediate NS or elevated vaginal pH. The study product warrants a randomized controlled trial to further assess efficacy.