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NCT03696953 · ClinicalTrials.gov registry record · Phase 2
The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.
A Phase 2 study of Gastrointestinal Symptoms and Group B Streptococcus Carrier in Childbirth, sponsored by Marquette University.
- Active
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT03696953 is a Phase 2 study of Gastrointestinal Symptoms and Group B Streptococcus Carrier in Childbirth that is active but no longer recruiting, run by Marquette University. The registered enrollment target is 109 participants, above the 58-participant average among 4 other Gastrointestinal Symptoms trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03696953, a Phase 2 study of Gastrointestinal Symptoms and Group B Streptococcus Carrier in Childbirth, is active but no longer recruiting, sponsored by Marquette University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL Florajen3
Study Locations (1)
Wisconsin
- Aurora Sinai Medical Center - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03696953
The ClinicalTrials.gov registry entry for NCT03696953 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 58-participant average among 4 other Gastrointestinal Symptoms trials with a reported enrollment target (88% higher). The listed sponsor is Marquette University, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Gastrointestinal Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Florajen3 is the first listed.
NCT03696953 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03696953 about?
NCT03696953 is a clinical study titled "The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.". 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 colonizatio...
What is the current status of trial NCT03696953?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2019-02-01. Estimated completion is 2024-09-30.
What conditions does trial NCT03696953 study?
This clinical trial studies the following conditions: Gastrointestinal Symptoms, Group B Streptococcus Carrier in Childbirth.
What interventions are being tested in trial NCT03696953?
The interventions under investigation include: Florajen3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03696953?
This trial is sponsored by Marquette University, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03696953 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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