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Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization

NCT03407157 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-09-13

No results posted yet for this study

Summary

This is a double-blind randomized placebo controlled trial that will investigate whether the use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation will reduce the incidence of Group B Streptococcus (GBS) colonization. Participants will take 2 capsules and 1 lozenge per day of either probiotic or placebo from 25 weeks gestation. The primary outcome will be the study-specific vaginal/rectal swab collected after 35 weeks gestation and before delivery. A reduction in women testing positive for GBS would lead to a decrease risk to infants of GBS infection and a reduction in the use of antibiotics leading to less maternal and neonatal antibiotic exposure.

Conditions

  • Group B Streptococcus Carrier in Childbirth

Interventions

DIETARY_SUPPLEMENT

Probiotic supplementation

Participants will take two capsules daily of Urex Plus VCap-5 (each containing 2.5 billion CFUs of L. rhamnosus and L. reuteri) and one lozenge of Blis K12 (1 billion CFUs of streptococcus Salivarius)

OTHER

Placebo

Participants will be asked to take 2 placebo capsules and 1 placebo lozenge daily from 25 weeks pregnancy

Sponsors & Collaborators

  • Dublin City University

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Michelle M Butler, PhD, RM · Dublin City University

  • Patricia Janssen, PhD · UBC School of Population and Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407157 on ClinicalTrials.gov