Open-label randomized controlled trial and feasibility study of an oral probiotic intervention to reduce group B streptococcus colonization in pregnant people by the time of birth

Authors

Katrina Nardini, Midwifery Division, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Lisa Hanson, College of Nursing, Marquette University, Milwaukee, Wisconsin.
Noelle Borders, Midwifery Division, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Maharaj Singh, College of Nursing, Marquette University, Milwaukee, Wisconsin.
Anna Shields, Midwifery Division, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Victoria Y. Trujillo, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Robyn Lawton, Midwifery Division, Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico.
Emily Malloy, Advocate Health - MidwestFollow

Recommended Citation

Nardini K, Hanson L, Borders N, et al. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025;70(3):460-467. doi:10.1111/jmwh.13765

Affiliations

Aurora Sinai Midwifery and Wellness Center

Abstract

Introduction:The purpose of this midwife-led study was to determine the feasibility of a randomized controlled trial (RCT) of probiotics to reduce group B Streptococcus (GBS) colonization by the time of birth in healthy, GBS-positive, pregnant adults.

Methods:An open-label randomized clinical trial comparing Florajen Digestion, a commercially available combination oral probiotic, with usual care (ClinicalTrials.gov NCT04721912 ) was conducted in a midwifery practice serving a racially and ethnically diverse population. Eligible patients who tested positive for GBS at routine third-trimester screening were offered informed consent and participation. The primary outcome was feasibility for a larger RCT, including feasibility of probiotic use among participants. Secondary outcomes were intrapartum GBS colonization and Antepartum Gastrointestinal Symptoms of Pregnancy (AP-GI-SA) scores.

Results:A total of 68 participants were enrolled and randomized; 65 participants completed the study, but only 46 had intrapartum cultures collected and processed. Among the 23 pregnant individuals who were eligible but chose not to participate, 3 indicated that they did not want to take a probiotic. After an average of 14 days of the intervention, 7 of 25 (28%) participants in the probiotic group had a negative intrapartum GBS result compared with 3 of 21 (14.3%) in the control group (odds ratio, 2.33; 95% CI, 0.52-10.48). There was no difference in perinatal outcomes or AP-GI-SA scores between groups. No adverse events occurred.

Discussion:The feasibility of a larger RCT was demonstrated. Challenges identified included intrapartum GBS collection and laboratory processing during the COVID-19 pandemic. The study was not powered to detect a significant difference in intrapartum GBS colonization, although a larger decrease in GBS colonization was noted among probiotic-using participants. Florajen Digestion may show efficacy in a RCT with a longer intervention period. It is possible that the probiotic intervention duration was too brief to show a reduction in gastrointestinal pregnancy symptoms.

Type

Article

PubMed ID

40442923