Group B Streptococcus Response After Probiotic Exposure

Completed · Phase 3

Conditions studied: Group B Strep Infection

In brief

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).

Key facts

Study ID

NCT04721912

Run by

University of New Mexico

People needed

68

Starts

2020-12-24

Expected to finish

2023-08-31

Last updated by the study team

2025-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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