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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: Probiotic dietary supplement||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
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
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53201-0342|
|Principal Investigator:||Lisa C Hanson, PhD, CNM||Marquette University|