Group B Streptococcus Response After Probiotic Exposure

Phase 3

Completed

Conditions: Group B Strep Infection

Interventions: Drug: Probiotic dietary supplement

Registration Number: NCT04721912

Lead Sponsor: University of New Mexico

Brief Summary: This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. Investigators hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L\&D).

Detailed Description: This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term. We hope to address the question of whether prenatal oral probiotic use, taken by healthy low risk GBS positive women from approximately 37 weeks gestation until the time of birth, will reduce the number of women who test positive for GBS at the time of admission to Labor and Delivery (L\&D). In this study we aim to determine whether such a study is acceptable in our population, whether any adverse events are identified, and what barriers or confounding variables might exist to probiotic use at term. We will also look at whether probiotic use had any reported effect on maternal gastrointestinal (GI) symptoms.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 68

Inclusion Criteria

• Healthy adult (≥ 18 years of age) pregnant women who are 36 - 37 6/7 weeks gestation at enrollment [calculated from the first day of Last Normal Menstrual Period (LNMP) and/or ultrasound (US)]

Group B Streptococcus Positive at 36 weeks gestation with:

No obstetric complication requiring delivery prior to 39 weeks (hypertensive disorder diagnosed prior to enrollment, gestational diabetes, multiple gestation)
No fetal complication (e.g., birth defect, intrauterine growth restriction)
No medical complication (e.g., chronic hypertension, preexisting diabetes mellitus)
Who do not currently ingest an over the counter probiotic supplement (not including yogurt)
Who can both speak and read English or Spanish
Pregnant women who regularly attend UNM prenatal clinics for their prenatal care ("regularly attend" will be defined as starting prenatal care prior to 20 weeks gestation and missing no more than one prenatal appointment during this pregnancy)
No hypersensitivity reaction to β-lactam antibiotics

Exclusion Criteria

Those less than 18 years of age
Non-pregnant women
Later in pregnancy than 38 weeks gestation at enrollment [per LNMP and/or US]
Those with an obstetric, fetal or medical complication of pregnancy
Group B Streptococcus negative at 36 weeks gestation. Those ineligible for testing at 36 weeks gestation (history of GBS bacteriuria during the current pregnancy or have previously given birth to a GBS affected child.) We will not exclude those with bacteriuria other than GBS, and we will not exclude women who have taken an antibiotic during pregnancy, but we will track this as it is addressed in the Questionnaire for Women.
Women who are currently ingesting an over the counter probiotic supplement (except for yogurt)
Women who do not have electricity in the home.
Women who are planning an elective repeat cesarean birth
Women who do not speak and read English or Spanish
Women with a history of missing one or more scheduled prenatal visit during this pregnancy
Hypersensitivity reaction to β-lactam antibiotics

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Dietary Supplement	Probiotic dietary supplement	Participants in the intervention group will begin taking oral study Probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth. The research staff member will sequentially distribute the pre-labeled bottles of study capsules to the intervention group, one bottle of 30 Florajen Digestion probiotic capsules to women in the intervention group at the time of randomization.

Primary Outcome Measures

Name	Time	Method
GBS Culture Result (Positive Versus Negative)	T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)	Qualitative GBS colonization (positive versus negative)

Secondary Outcome Measures

Name	Time	Method
Probiotic Pill Count to Measure Intervention Adherence	T3 (Postpartum day 0-14, up to 8 weeks from Baseline)	Intervention adherence by pill count for probiotic participants
Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score	Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)	Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)
Number of Participants Who Report Adverse Events	T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)	Maternal adverse events by organ system and severity.
Number of Participants Who Report Adverse Events in Their Infant	T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)	Infant adverse events by organ system and severity