Your session is about to expire
← Back to Search
Probiotic
Florajen3 for Group B Strep Carrier
Phase 2
Waitlist Available
Led By Lisa C Hanson, PhD
Research Sponsored by Marquette University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of admission to the hospital for labor and birth (intrapartum) (time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)
Awards & highlights
Study Summary
This trial is to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization.
Who is the study for?
This trial is for healthy adult pregnant women at 28±2 weeks gestation, who speak and read English, attend regular prenatal care, and have no fetal or medical complications like birth defects or diabetes. It's not for those taking over-the-counter probiotics (except yogurt), with a history of severe reactions to β-lactam antibiotics, or any obstetric complications.Check my eligibility
What is being tested?
The study tests if the oral probiotic Florajen3 can reduce Group B Streptococcus colonization in pregnant women. Participants are randomly assigned to receive either Florajen3 or a placebo without knowing which one they get. The study measures GBS levels at around 36 weeks of pregnancy and effects on maternal and neonatal GBS during labor.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, common side effects from probiotics may include digestive discomfort such as gas or bloating. However, these tend to be mild.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of admission to the hospital for labor and birth (intrapartum) (time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of admission to the hospital for labor and birth (intrapartum) (time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Qualitative GBS Culture Result
Secondary outcome measures
Antepartum Gastrointestinal Symptom Assessment
GBS Quantitative Colony Counts in Colony Forming Units (CFU)
Other outcome measures
Intrapartum GBS Culture Result
Neonatal GBS Oral/Nasopharynx Colonization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ProbioticExperimental Treatment1 Intervention
Florajen3 Combination Probiotic Product 15 billion CFU per capsule
1 capsule daily from 28 weeks until the time of birth.
Group II: PlaceboActive Control1 Intervention
Microcrystalline Cellulose
Find a Location
Who is running the clinical trial?
Aurora Health CareOTHER
42 Previous Clinical Trials
15,923 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,278 Total Patients Enrolled
Marquette UniversityLead Sponsor
62 Previous Clinical Trials
200,214 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger