Group B Streptococcus Response After Probiotic Exposure

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified December 2024 by University of New Mexico
Sponsor
University of New Mexico
Information Provided by (Responsible Party)
Katrina A. Nardini
Clinicaltrials.gov Identifier
NCT04721912
Other Study ID Numbers:
20-396
First Submitted
December 6, 2020
First Posted
January 24, 2021
Results First Posted
September 4, 2024
Last Update Posted
January 13, 2025
Last Verified
December 2024

ClinicalTrials.gov processed this data on January 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Group B Strep Infection
Drug: Probiotic dietary supplement

Study Design

Study TypeInterventional
Actual Enrollment68 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleOpen-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.
Study Start DateDecember 23, 2020
Actual Primary Completion DateAugust 30, 2023
Actual Study Completion DateAugust 30, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Standard of Care
Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.
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.
Drug: Probiotic dietary supplement
GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.

Outcome Measures

Primary Outcome Measures
  1. GBS Culture Result (Positive Versus Negative)
    Qualitative GBS colonization (positive versus negative)
Secondary Outcome Measures
  1. Probiotic Pill Count to Measure Intervention Adherence
    Intervention adherence by pill count for probiotic participants
  2. Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
    Maternal gastrointestinal (GI) symptoms based on AP-GI-SA score: lowest score 10, highest score 50 (high score means more symptoms = worse outcome)
  3. Number of Participants Who Report Adverse Events
    Maternal adverse events by organ system and severity.
  4. Number of Participants Who Report Adverse Events in Their Infant
    Infant adverse events by organ system and severity

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsUniversity of New Mexico
Locations
University of New Mexico Hospital | Albuquerque New Mexico, United States, 87112
Investigators
Principal Investigator: Katrina Nardini, University of New Mexico
Study Documents (Full Text)
Documents provided by University of New Mexico: Study Protocol and Statistical Analysis Plan  December 1, 2021