Clinical trial NCT04721912: Group B Streptococcus Response After Probiotic Exposure
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Group B Strep Infection
Keywords: pregnancy
Group B Strep positive
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2021-01-25
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy pregnant participants will be randomly assigned to one of two groups (Probiotic vs No Probiotic (standard of care)). The Probiotic group will take one capsule daily and have the same study measures at the same times.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: GBS Culture Result (Positive Versus Negative)
timeFrame: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
Secondary outcomes:
measure: Probiotic Pill Count to Measure Intervention Adherence
timeFrame: T3 (Postpartum day 0-14, up to 8 weeks from Baseline)
measure: Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score
timeFrame: Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)
measure: Number of Participants Who Report Adverse Events
timeFrame: T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)
measure: Number of Participants Who Report Adverse Events in Their Infant
timeFrame: 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)
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Katrina Nardini
role: PRINCIPAL_INVESTIGATOR
References: