Status:
COMPLETED
Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization
Lead Sponsor:
Marquette University
Collaborating Sponsors:
Wake Forest University Health Sciences
University of Wisconsin, Madison
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This pilot quasi experiment was designed to determine the feasibility of a randomized controlled trial of the oral probiotic combination of Florajen3 (\>7.5 x109 L. acidophilus, \>6.0 x109. B. lactis,...
Detailed Description
Methods A non-blinded, open-label, quasi-experimental design was approved by the Institutional Review Boards of three institutions (two universities and the clinical research site). The study setting...
Eligibility Criteria
Inclusion
- Low risk pregnancy (no obstetric, fetal, medical or genetic risk factors)
- Adult (≥18 years of age)
- Pregnant at 28 ± 2 weeks gestation
- Able to speak and write English
- Willingness to participate in the study intervention (oral probiotic) and data collection (including vaginal and rectal swabs and questionnaires)
Exclusion
- Pregnant women with obstetric, fetal, medical, or genetic risk factors.
- \<18 years of age
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02249325
Start Date
January 1 2011
End Date
June 1 2013
Last Update
October 7 2014
Active Locations (1)
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1
Aurora Healthcare
Milwaukee, Wisconsin, United States, 53201-0342