Phase 3 N=68 Randomized Treatment

Group B Streptococcus Response After Probiotic Exposure

Group B Strep Infection

Bottom Line

View on ClinicalTrials.gov: NCT04721912 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: GBS Culture Result (Positive Versus Negative) — 3; 6; 18; 19 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Probiotic dietary supplement (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of New Mexico
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY GBS Culture Result (Positive Versus Negative)	3; 6; 18; 19	—
SECONDARY Probiotic Pill Count to Measure Intervention Adherence	14	—
SECONDARY Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score	15.6; 15.0; 14.5; 13.5	—
SECONDARY Number of Participants Who Report Adverse Events	0; 0	—
SECONDARY Number of Participants Who Report Adverse Events in Their Infant	0; 0	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04721912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.