Status:
UNKNOWN
Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Dublin City University
Conditions:
Group B Streptococcus Carrier in Childbirth
Eligibility:
FEMALE
18-55 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Background: Group B streptococcus (GBS) infection of the newborn is a leading cause of neonatal morbidity and mortality in North America. Up to 30% of pregnant women are colonized with GBS. Half of t...
Eligibility Criteria
Inclusion
- Pregnant with a singleton
- Gestational age between 23 and 25+0 weeks
- Over the age of 18
- Registered for delivery, at one of the participating centres
- Under the care of a regulated maternity care provider (midwife, obstetrician (OB), or family physician).
Exclusion
- Unable to provide consent
- Fetus has known major anomalies
- Significant immunosuppression
- Type I or Type II diabetes (non-gestational)
- Previous infant with GBS (these women will automatically be advised to be treated with IV antibiotic therapy)
- GBS bacteriuria diagnosed in present pregnancy (reasoning as per above)
- Plans to use oral or vaginal probiotic supplementation/therapy (capsules/tablets/lozenges/drinks) during their pregnancy (outside of natural food sources; yogurt, kimchi, kombucha etc)
- Enrolled in another study that involves the administration of a drug/product
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT03407157
Start Date
January 16 2020
End Date
December 31 2024
Last Update
September 13 2023
Active Locations (2)
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1
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6