Group B Streptococcus Response After Probiotic Exposure (GRAPE)

Open-label Randomized Control Trial and Feasibility Study of Florjajen Digestion Probiotics to Reduce GBS Colonization in Pregnant Women by the Time of Birth.

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).

Study Overview

• Status: Completed
• Conditions: Group B Strep Infection
• Intervention / Treatment: Drug: Probiotic dietary supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87112
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.; Other Names: Florajen Digestion™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GBS culture result (positive versus negative)	Qualitative GBS colonization (positive versus negative), at the time of admission to Labor and Delivery.	36 - 42 weeks gestational age (admission to Labor and Delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probiotic pill count to measure intervention adherence	Intervention adherence by pill count for probiotic participants	Postpartum (day 0-14)
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)	Baseline (36-37.6 weeks gestational age) and postpartum (day 0-14)
Number of participants who report adverse events	Maternal adverse events by organ system and severity	Weekly prenatal visits starting at time of enrollment until time of delivery (37-42 weeks gestational age and 2 weeks and 6 weeks postpartum visits)
Number of participants who report adverse events in their infant	Infant adverse events by organ system and severity	2 weeks and 6 weeks postpartum visits

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Marquette University
• Investigators: Principal Investigator: Katrina Nardini, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Estimated): May 15, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: pregnancy; Group B Strep positive
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections
• Other Study ID Numbers: 20-396

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes