Effects of Probiotic Use During Pregnancy on Lactobacillus and Group B Streptococcus Vaginal Colonization: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Marquette University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Prenatal group B Streptococcus Colonization
Study Overview
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.
Detailed Description
Methods
A non-blinded, open-label, quasi-experimental design was approved by the Institutional Review Boards of three institutions (two universities and the clinical research site). The study setting was a large Certified Nurse-Midwife (subsequently referred to as midwife) clinical practice serving a culturally and economically diverse urban population in the Midwest region of the USA.
Participants Women self-selected to participate in screening and informed consent procedures done by the first two authors. The following inclusion criteria were used at study enrollment: low risk (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, and expressing willingness to participate in the study intervention (oral probiotic) and data collection (vaginal and rectal swabs, questionnaires).
A convenience sample of 20 healthy pregnant participants was sought. Following informed consent, the first 10 subjects were assigned to the experimental group. Nonrandom assignment was used to assure that the 10 experimental group participants were enrolled while remaining within funding, and time constraints. After enrolling the experimental group, the next ten women were assigned to the control group.
Intervention
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Probiotic dietary supplement (Dietary Supplement)
Placebo
Women in the comparison group did not take a placebo.
Outcomes
Primary Outcomes
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 Outcomes
- Recruitment and retention of a diverse sample.(28 to 36 weeks gestation)
Investigators
Lisa Hanson
Associate Professor
Marquette University