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8 Evaluation of probiotic oral supplementation effects on group B streptococcus rectovaginal colonization in pregnant women: a randomized double-blind placebo-controlled trial N. Aziz, A. Spiegel, J. Bentley, P. Yoffe, A. Klikoff, K. Ehrlich, Y. El-Sayed, W. Benitz, M. Norton, M. Taslimi Stanford University School of Medicine, Stanford, CA, Aptos Women’s Health, Santa Cruz, CA OBJECTIVES: Recently, lactobacilli-containing probiotics have been studied for use in a variety of conditions, including urogenital infections. We sought to determine if antenatal probiotic supplementation during second and third trimesters reduces maternal GBS rectovaginal colonization in pregnant women at 35-37 weeks’ gestational age. METHODS: We conducted a multi-site, prospective, randomized double-blind placebo-controlled trial. Pregnant women with singleton gestation were enrolled prior to 28 weeks’ gestation to daily oral probiotic (Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14l; 5.4 billion CFU per capsule) vs placebo. Primary outcome was GBS rectovaginal colonization status in pregnant women at 35-37 weeks’ gestational age. Secondary outcomes included perinatal infectious events. Descriptive statistics, Fisher’s exact test, and the t-test were used to compare characteristics between women randomized to either probiotic or placebo arm. Study outcomes were compared between arms using Fisher’s exact test and according to the intention to treat principle. RESULTS: A total of 251 subjects were randomized to probiotic (n1⁄4125) or placebo (n1⁄4126). The two cohorts were similar in demographic, infectious, and treatment duration characteristics. On average, subjects in each group completed 12 weeks of intervention prior to time at which culture was obtained. No significant difference was found in GBS rectovaginal colonization at 35-37 weeks’ gestation between probiotic supplementation vs. placebo (18.5% vs. 19.7%, p1⁄40.87). Secondary outcomes were also not different between the two study arms. CONCLUSIONS: Our findings found no difference in rectovaginal colonization rates at 35-37 weeks’ in pregnant women on probiotic supplementation vs. placebo during second and third trimesters at the specified dose and duration used in our study. Larger studies, examining perhaps different dosage and duration, are needed to further investigate the potential impact of probiotics on GBS rectovaginal colonization during pregnancy.