CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 109 enrolled
Drug / intervention
Florajen3biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03696953
NCT03696953Phase 2Unknown

The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization

Marquette University·interventional·Posted Oct 5, 2018·Updated Mar 21, 2024

In Brief

A Phase 2 clinical trial evaluating Florajen3 for Group B Streptococcus Carrier in Childbirth and Gastrointestinal Symptoms. Targeting 109 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2UnknownOverdue
20192020202120222023202420252026
First PostedOct 5, 2018
Enrollment StartFeb 1, 2019
Primary CompletionSep 30, 2022
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.7 years ago

Interventions

Florajen3biological

Probiotic combination product One capsule daily by mouth.