Group B Streptococcus Response After Probiotic Exposure

Group B Strep Infection Clinical Trial

— GRAPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04721912
• Other study ID #: 20-396
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 24, 2020
• Est. completion date: April 16, 2024

Study information

• Verified date: April 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ß-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 ß-lactam antibiotics

Related Conditions & MeSH terms

• Group B Strep Infection
• Streptococcal Infections

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probiotic pill count to measure intervention adherence	Intervention adherence by pill count for probiotic participants	Postpartum (day 0-14)
Secondary	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)
Secondary	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)
Secondary	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