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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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04721912
Study type Interventional
Source University of New Mexico
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 24, 2020
Completion date April 16, 2024

See also
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Active, not recruiting NCT04653948 - Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Completed NCT03807245 - Group B Streptococcus Vaccine in Healthy Females Phase 1
Active, not recruiting NCT04549220 - Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Recruiting NCT04732026 - Serocorrelate of Protection Against GBS (PREPARE WP3)