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The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.

NCT03696953 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-03-21

Study results available
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Summary

This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group.

Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.

Conditions

  • Group B Streptococcus Carrier in Childbirth
  • Gastrointestinal Symptoms

Interventions

BIOLOGICAL

Florajen3

Probiotic combination product One capsule daily by mouth.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Marquette University

    lead OTHER

Principal Investigators

  • Lisa C Hanson, PhD · Marquette University, College of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696953 on ClinicalTrials.gov