Group B Streptococcus Response After Probiotic Exposure

NCT04721912 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20-396
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Group B Strep Infection

Keywords

pregnancy; Group B Strep positive

Outcome Measures

Primary Outcomes (1)

• GBS Culture Result (Positive Versus Negative)

  Qualitative GBS colonization (positive versus negative)

  T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)

Secondary Outcomes (4)

• Probiotic Pill Count to Measure Intervention Adherence

  T3 (Postpartum day 0-14, up to 8 weeks from Baseline)

• Antepartum Gastrointestinal Symptom Assessment (AP-GI-SA) Score

  Baseline T1 (36-37.6 weeks gestational age) and T3 (postpartum day 0-14; up to 8 weeks from baseline)

• Number of Participants Who Report Adverse Events

  T1 (baseline; 36.0-37.6 weeks gestational age) through T5 (6 weeks postpartum visit; up to 12 weeks and 6 days from baseline)

• Number of Participants Who Report Adverse Events in Their Infant

  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)

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects in the control group will not receive any Probiotic capsules and will be advised to continue their routine prenatal self-care.

Probiotic Dietary Supplement

EXPERIMENTAL

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

Interventions

Probiotic dietary supplement DRUG

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.

Also known as: Florajen Digestion™

Probiotic Dietary Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of New Mexico: lead
• Marquette University: collaborator

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87112, United States

Location

Related Publications (1)

• Nardini K, Hanson L, Borders N, Singh M, Shields A, Trujillo VY, Lawton R, Malloy E. Open-Label Randomized Controlled Trial and Feasibility Study of an Oral Probiotic Intervention to Reduce Group B Streptococcus Colonization in Pregnant People by the Time of Birth. J Midwifery Womens Health. 2025 May-Jun;70(3):460-467. doi: 10.1111/jmwh.13765. Epub 2025 May 29.

  PMID: 40442923 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

Participants and researchers were not masked to group assignment which may have led to unintended biases in responses and interpretation of questionnaires. Several IP samples were missed. The COVID-19 pandemic limited recruitment and may have prevented recruitment of those who would otherwise have participated. There were significant problems with laboratory processing of IP GBS swabs, resulting in 23 laboratory samples not being analyzed.

Results Point of Contact

• Title: Katrina Nardini, CNM, WHNP-BC, MPH
• Organization: University of New Mexico

hsc-familyplanningresearch@salud.unm.edu

505-205-4118

Study Officials

• Katrina Nardini

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, CNM, WHNP-BC, MPH

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: January 25, 2021
• Study Start: December 24, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

US (1)