Group B Streptococcus Response After Probiotic Exposure

NCT ID: NCT04721912

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-24
• Study Completion Date: 2023-08-31

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.

Conditions

Group B Strep Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Probiotic dietary supplement

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Florajen Digestion™

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Katrina A. Nardini

Principle Investigator, CNM, WHNP-BC, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katrina Nardini

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Hospital

Albuquerque, New Mexico, United States

Countries

United States

References

Nardini K, Hanson L, Borders N, Singh M, Shields A, Trujillo VY, Lawton R, Malloy E. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025 May-Jun;70(3):460-467. doi: 10.1111/jmwh.13765. Epub 2025 May 29.

Reference Type: DERIVED

PMID: 40442923 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-396

Identifier Type: -

Identifier Source: org_study_id