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

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 |

Arm | Intervention/treatment |
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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.
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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.
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- 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.

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

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 | |
Aurora Healthcare | |
Milwaukee, Wisconsin, United States, 53201-0342 |
Principal Investigator: | Lisa C Hanson, PhD, CNM | Marquette University |
Responsible Party: | Lisa Hanson, Associate Professor, Marquette University |
ClinicalTrials.gov Identifier: | NCT02249325 |
Other Study ID Numbers: |
HR-2090 |
First Posted: | September 25, 2014 Key Record Dates |
Last Update Posted: | October 7, 2014 |
Last Verified: | October 2014 |
group B Streptococcus colonization Probiotic Pregnancy |