Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Gastrointestinal Symptoms and Group B Streptococcus Carrier in Childbirth, sponsored by Marquette University.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT03696953 still lists
NCT03696953 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 4 other Gastrointestinal Symptoms trials with a reported enrollment target (88% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Gastrointestinal Symptoms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
RECRUITING · Phase 1
-
An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System
RECRUITING · NA
-
Mechanisms of Gulf War Illness
RECRUITING · NA
-
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI