NCT03696953

The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.

Status unknown Phase 2 Results posted Last updated 21 March 2024

What this trial tests

Phase 2 trial testing Florajen3 in Group B Streptococcus Carrier in Childbirth in 109 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
30 September 2022

30 September 2024

Quick facts

Lead sponsor	Marquette University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	109
Start date	1 February 2019
Primary completion	30 September 2022
Estimated completion	30 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Florajen3 — full drug profile →

Conditions studied

• Group B Streptococcus Carrier in Childbirth — all drugs for Group B Streptococcus Carrier in Childbirth →
• Gastrointestinal Symptoms — all drugs for Gastrointestinal Symptoms →

Sponsor

Marquette University

Who can join

18 and older, female only, with Group B Streptococcus Carrier in Childbirth or Gastrointestinal Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Qualitative GBS Culture Result Primary · 36 weeks gestation

Qualitative GBS culture results

Group	Value	95% CI
Probiotic	6
Placebo	9
Probiotic	33
Placebo	35

GBS Quantitative Colony Counts in Colony Forming Units (CFU) Secondary · 36 weeks gestation

Amount of GBS on each vaginal and rectal swab. Each swab was vortexed in 1 mL of PBS and plated onto Granada agar. Quantitative GBS colonization measured as the number of GBS colonies on Granada agar plate multiplied by the inverse of the dilution factor. The results were reported in CFU. No GBS present indicates negative. Positive results are reports numerically.

Vaginal

Group	Value	95% CI
Probiotic	11.32	± 6.65
Placebo	317.1	± 1957.1

Rectal

Group	Value	95% CI
Probiotic	604.2	± 2684.2
Placebo	2046.6	± 12805.4

Antepartum Gastrointestinal Symptom Assessment Secondary · 36 weeks gestation

Antepartum Gastrointestinal Symptom Assessment Scores The Antepartum Gastrointestinal Symptom Assessment is a composite of 10 GI symptoms (Nausea, Vomiting, Diarrhea, Sour Taste, Bad Breath, Burping/Belching, Bloating, Heartburn, Diarrhea, Constipation) each scored from 1 (no problem) to 5 (very severe problem), leading to a composite score between 10-50. Lower scores indicate fewer and/or less severe GI symptoms. Higher scores indicate more frequent and/or more severe GI symptoms.

Baseline (28 week) AP-GI-SA Score

Group	Value	95% CI
Probiotic	14.7	± 3.2
Placebo	16.2	± 4.8

36 week AP-GI-SA Score

Group	Value	95% CI
Probiotic	13.58	± 2.77
Placebo	15.64	± 3.96

Intrapartum GBS Culture Result Secondary · At the time of admission to the hospital for labor and birth (intrapartum) (Time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)

Number of women with positive GBS vaginal to rectal colonization at the time of admission to the hospital for labor and birth. This measure was only collected on participants in the substudy.

Intrapartum Culture Positive

Group	Value	95% CI
Probiotic	3
Placebo	3

Intrapartum Culture Negative

Group	Value	95% CI
Probiotic	11
Placebo	12

GBS culture changed to Positive (36 weeks to negative Intrapartum

Group	Value	95% CI
Probiotic	1
Placebo	2

GBS culture changed to Negative (36 weeks to positive Intrapartum

Group	Value	95% CI
Probiotic	1
Placebo	0

Neonatal GBS Oral/Nasopharynx Colonization Secondary · 1-2 hours of life

Number of Neonates with Positive GBS ) oral/nasopharynx colonization within 1-2 hours of life

Group	Value	95% CI
Probiotic	0
Placebo	0

Sponsor's own description

This study is a randomized double blind, placebo controlled trial to determine the efficacy of an oral probiotic in reducing antenatal Group B Streptococcus colonization. The goal of this study is to demonstrate that women in the probiotics group will experience; (1) reduced GBS prenatal colonization at 36± 2 weeks gestation and lower levels of GBS colonization, (2) less need for intrapartum antibiotic prophylaxis and (3) fewer prenatal gastrointestinal symptoms compared to women in the placebo group.

Intrapartum measures were added and IRB approved in Feb 2020 as a pilot and feasibility substudy. The goals of this study are as follows: (1) Explore the effect of antepartum exposure to Florajen3 on maternal and neonatal residual GBS and the maternal microbiome. We anticipate that (1)At the time of labor, more women in the probiotics group will test negative for GBS on vaginal to rectal swabs compared to those in the placebo group and (2) Fewer neonates born to women in the probiotic group will have GBS on nasal-oral pharynx cultures within several hours of birth compared to those born to neonates in the control group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Participant Personal Characteristics and Adherence to Oral Capsules: A Secondary Analysis of a Randomized Placebo-Controlled Trial of Antenatal Probiotics.
   Hanson L, Albert K, Malloy E, Singh M, et al · · 2025 · PMID 39351987 · DOI 10.1111/jmwh.13686
2. Vaginal and Rectal microbiome changes following administration of a multi-species antenatal probiotic: A randomized control trial.
   Malloy E, Kates AE, Dixon J, Riley C, et al · · 2024 · PMID 38708373 · DOI 10.1080/29933935.2024.2334311