BACKGROUND:
Antepartum Group B (GBS) colonization poses significant risks to pregnant people and newborns world-wide. Midwives suggested oral probiotics as a primary prevention strategy.

OBJECTIVES:
The objectives, settings, samples, methods and findings of 3 midwifery-led clinical trials of oral antenatal probiotic interventions to reduce antenatal GBS colonization in healthy pregnant adults with be presented including challenges, limitations, and plans for future research. The 3 studies included; (I) An open-label quasi-experiment, (II) A double-blind, randomized placebo controlled trial, (III) An open-label randomized trial.

METHODS:
Study methods included; (I) In an open-label quasi-experiment, 10 participants took a daily capsule of Florajen 3, and 10 served as controls. (II) In an NIH funded, phase two randomized controlled trial (RCT), 83 participants were randomized to Florajen 3 or placebo capsule beginning at 28-weeks gestation, with GBS colonization determined at 36 weeks in both groups. (III) In an open-label randomized trial, Florajen Digestion once-daily was administered to 68 GBS positive participants at 37-38 weeks gestation. The primary outcome was intrapartum GBS colonization.

RESULTS:
No adverse events occurred. Major findings included; (I) In the open-label quasi-experiment the probiotic and study measures were well-tolerated, signaling that a larger trial was feasible. (II) In the RCT, 83 participants completed the study to 36 weeks gestation. GBS colonization in the control group was 20.4% compared to 15.4% in probiotic group participants (-5%; p=0.73). (III) In the open-label randomized trial, 46 intrapartum cultures collected and processed. After an average of 14 days of the intervention, 7 of 25 (28%) in the probiotic group were GBS negative at the time of birth compared to 3 of 21 (14.3%) to controls (OR, 2.33; 95% CI, 0.52-10.48).

CONCLUSIONS:
Probiotic interventions reduced antenatal GBS colonization 5-14% in 2 of 3 clinical trials.

KEY MESSAGE:
More research is needed to shift the paradigm to recommend oral antepartum probiotics to prevent GBS colonization. Mental health (Including three-minute presentation competition)