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Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization

NCT02249325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-07

No results posted yet for this study

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, and \>1.5 x109 B. longum) taken orally once daily beginning at 28 weeks gestation, against placebo, to reduce the colonization of group B Streptococcus at 36 weeks.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

Probiotic dietary supplement

Florajen3 is a commercially available probiotic supplement containing three bacteria of human origin (\>7.5 x10\^9 L. acidophilus, \>6.0 x10\^9 .B. lactis, and \>1.5 x10\^9 B .longum). Once capsule was administered daily by mouth from 28 through 36 weeks gestation.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Marquette University

    lead OTHER

Principal Investigators

  • Lisa C Hanson, PhD, CNM · Marquette University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-10-31
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02249325 on ClinicalTrials.gov