NCT04721912

Group B Streptococcus Response After Probiotic Exposure

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Group B Strep Infection

Interventions

Type	Name	Description
DRUG	Probiotic dietary supplement	GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.

Timeline

• Start date: 2020-12-24
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2021-01-25
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study