Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization

NCT02249325 | Completed

• 1 other identifier: HR-2090
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

group B Streptococcus colonization; Probiotic; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Prenatal group B Streptococcus Colonization

  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.

  36 weeks gestation

Secondary Outcomes (1)

• Recruitment and retention of a diverse sample.

  28 to 36 weeks gestation

Study Arms (2)

Probiotic dietary supplement

EXPERIMENTAL

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

Placebo

NO INTERVENTION

Women in the comparison group did not take a placebo.

Interventions

Probiotic dietary supplement 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.

Also known as: Florajen3 Probiotic

Probiotic dietary supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant women with obstetric, fetal, medical, or genetic risk factors.
• \<18 years of age

Sponsors & Collaborators

• Marquette University: lead
• Wake Forest University Health Sciences: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Aurora Healthcare

Milwaukee, Wisconsin, 53201-0342, United States

Location

Related Publications (1)

• Hanson L, Vandevusse L, Duster M, Warrack S, Safdar N. Feasibility of oral prenatal probiotics against maternal group B Streptococcus vaginal and rectal colonization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):294-304. doi: 10.1111/1552-6909.12308. Epub 2014 Apr 22.

  PMID: 24754328 RESULT

Study Officials

• Lisa C Hanson, PhD, CNM

  Marquette University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: September 25, 2014
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: June 1, 2013
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

US (1)