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Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonisation (OPSiP trial): study
Kelly Hayes1,2, Patricia Janssen3, Beth A Payne4,5
1BCCHR, The University of British Columbia, Vancouver, British Columbia, Canada kelly.hayes@bcchr.ca.
Insights
This study investigates probiotics as an alternative to antibiotics for preventing Group B Streptococcus (GBS) in pregnant individuals. Researchers aim to reduce GBS colonization and associated neonatal risks without widespread antibiotic use.
Area of Science:
- Obstetrics and Gynecology
- Microbiology
- Clinical Trials
Background:
- Group B Streptococcus (GBS) is a major cause of neonatal illness and death.
- Current Canadian guidelines recommend universal maternal screening and selective antibiotic use, leading to significant antibiotic exposure for prevention.
- Concerns about antibiotic side effects necessitate exploring alternative strategies to reduce GBS colonization.
Purpose of the Study:
- To evaluate the efficacy of a specific probiotic formulation in reducing GBS colonization rates in pregnant individuals.
- To compare GBS colonization rates between a probiotic intervention group and a placebo group.
- To assess secondary outcomes including maternal antibiotic exposure and urogenital infections.
Main Methods:
- A double-blind, parallel-group, randomized controlled trial involving 450 pregnant participants in Vancouver, BC.
- Participants received either a daily oral dose of three probiotic strains or a placebo.
- GBS colonization status was determined via vaginal/rectal swabs between 35 weeks' gestation and delivery.
Main Results:
- Primary outcome: GBS colonization status.
- Secondary outcomes: Maternal antibiotic exposure and urogenital infections.
- Intention-to-treat analysis will be employed.
Conclusions:
- Preliminary evidence suggests probiotics may offer protection against GBS colonization.
- This trial will provide crucial data on the effectiveness of probiotics as an alternative prevention strategy.
- Findings will inform clinical practice and potentially reduce neonatal GBS disease incidence.
Introduction:
Group B streptococcus (GBS), or Streptococcus agalactiae, remains a leading cause of neonatal morbidity and mortality. Canadian guidelines advise universal maternal screening for GBS colonisation in pregnancy in conjunction with selective antibiotic therapy. This results in over 1000 pregnant individuals receiving antibiotic therapy to prevent one case of early-onset neonatal GBS disease, and over 20 000 pregnant individuals receiving antibiotic therapy to prevent one neonatal death. Given the growing concern regarding the risk of negative sequela from antibiotic exposure, it is vital that alternative approaches to reduce maternal GBS colonisation are explored.Preliminary studies suggest some probiotic strains could confer protection in pregnancy against GBS colonisation.
Methods And Analysis:
This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks' gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis.
Patient Or Public Involvement:
There was no patient or public involvement in the design of the study protocol.
Ethics And Dissemination:
This study protocol received ethics approval from the University of British Columbia's Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications.
Trial Registration Number:
NCT03407157.
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