Group B Streptococcus Response After Probiotic Exposure — GRAPE  

Group B Strep Infection Clinical Trial

Official title: Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.

Status Completed

Clinical Trial Summary

This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L&D).

Clinical Trial Description

This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. We hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L&D). In this study we aim to determine whether such a study is acceptable in our population, whether any adverse events are identified, and what barriers or confounding variables might exist to probiotic use at term. We will also look at whether probiotic use had any reported effect on maternal gastrointestinal (GI) symptoms. ;

Related Conditions & MeSH terms

• Group B Strep Infection
• Streptococcal Infections

• NCT number: NCT04721912
• Study type: Interventional
• Source: University of New Mexico
• Status: Completed
• Phase: Phase 3
• Start date: December 24, 2020
• Completion date: August 31, 2023