Impact of oral administration of four strains on Nugent score - systematic review and meta-analysis.

We aimed at assessing the evidence for an effect on vaginal dysbiosis by oral administration of a mixture of strains isolated from vaginal microbiota. For this purpose, we systematically reviewed the literature for randomised clinical trials (RCTs) in which the effect of oral administration of a mixture of four strains ( LbV 88 (DSM 22566), LbV 150N (DSM 22583), LbV 116 (DSM 22567) and LbV96 (DSM 22560)) on vaginal dysbiosis was examined based on Nugent score. Four RCTs were identified: a double-blind (DB)-RCT in 60 male-to-female transsexual women with neovagina; an open label RCT in 60 pregnant women with herpes virus infection; a DB-RCT in 36 women with bacterial vaginosis; a DB-RCT in 22 postmenopausal breast cancer patients receiving chemotherapy. Only in the three DB-RCTs Nugent score was assessed. The meta-analysis of these trials showed a significant reduction of Nugent score by probiotics compared to placebo in the fixed (standardised mean differences (SMD) -0.561; confidence interval (CI) -0.935 to -0.186; =0.004 and random effect models (SMD -0.561; CI -0.935 to -0.186; =0.004). The odds ratio (OR) of the cases presenting with improved Nugent score after probiotics compared to placebo treatment showed a significant effect in the fixed (OR=3.936; CI 1.702 to 9.100; =0.001) and random effect model (OR=3.902; CI 1.681 to 9.059; =0.001) Cochran's Q and I statistics showed no heterogeneity. This meta-analysis indicates that the oral intake of the pertinent strains improves the microbial pattern in vaginal dysbiosis.