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Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization

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ClinicalTrials.gov Identifier: NCT02249325
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : October 7, 2014
Sponsor:
Collaborators:
Aurora Health Care
University of Wisconsin, Madison
Information provided by (Responsible Party):
Lisa Hanson, Marquette University

Study Description
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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, 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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Probiotic dietary supplement Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Probiotic Use During Pregnancy on Lactobacillus and Group B Streptococcus Vaginal Colonization: A Pilot Study
Study Start Date : January 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotic dietary supplement
Florajen3 oral probiotic (>7.5 x10^9 L. acidophilus, >6.0 x10^9 .B. lactis, and >1.5 x10^9 B .longum) taken daily beginning at 28 weeks gestation.
 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.
Other Name: Florajen3 Probiotic
No Intervention: Placebo
Women in the comparison group did not take a placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Prenatal group B Streptococcus Colonization [ Time Frame: 36 weeks gestation ]

    Routine prenatal GBS cultures were collected on all study participants at 35-37 weeks gestation as per the 2010 CDC GBS prevention guidelines. Only this result was use to determined the need for intrapartum antibiotic prophylaxis.

    All study participants received separate vaginal and rectal GBS culture swabs that were analyzed quantitatively for GBS/swab in Colony Forming Units (CFUs). These results were blind to the prenatal care providers.



Secondary Outcome Measures :
  1. Recruitment and retention of a diverse sample. [ Time Frame: 28 to 36 weeks gestation ]
    The clinical setting was a large, urban Nurse-Midwifery practice that serves an ethnically and economically diverse group of women.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • Pregnant women with obstetric, fetal, medical, or genetic risk factors.
  • <18 years of age
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249325


Locations
United States, Wisconsin
Aurora Healthcare
Milwaukee, Wisconsin, United States, 53201-0342
Sponsors and Collaborators
Marquette University
Aurora Health Care
University of Wisconsin, Madison
Investigators
Principal Investigator: Lisa C Hanson, PhD, CNM Marquette University
More Information
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Publications of Results:

Responsible Party: Lisa Hanson, Associate Professor, Marquette University
ClinicalTrials.gov Identifier: NCT02249325     History of Changes
Other Study ID Numbers: HR-2090
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Lisa Hanson, Marquette University:
group B Streptococcus colonization
Probiotic
Pregnancy