Clinical trial process and efficacy evaluation
After screening 546 BV patients with Nugent Score ≥7 according to the inclusion and exclusion criteria, 67 patients were included in the clinical trial and randomized. Among them, 8 subjects were excluded (4 subjects were lost to follow-up, 2 subjects were terminated due to non-medication as prescribed, and 2 subjects withdrew from this study for personal reasons). Ultimately, 31 subjects in the control group and 28 subjects in the probiotic group were included in the efficacy evaluation and microbiome analysis (Demographic and behavioral characteristics of subjects at baseline.At all time-points, there was no significant improvement in the cure rate in the probiotic group compared to the control group. The cure rates for the probiotic and control groups were 72.73% and 84.00% at day 14, respectively; 57.14%, and 60.00% at day 30, respectively; 32.14% and 48.39% at day 90, respectively. Notably, in the group of cured participants, the proportion of those fully recovered (Nugent Score < 4) was higher in the probiotic group compared to the control group (87.50% and 71.43% on day 14, 93.75% and 88.89% on day 30, and 77.78% and 66.67% on day 90, respectively) (Although orally administrated 