Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
1 other identifier
interventional
2,170
1 country
4
Brief Summary
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:
- Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants?
- Are there any adverse effects associated with the administration of this probiotic combination?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2025
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 5, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
February 5, 2025
January 1, 2025
2 years
January 20, 2025
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of necrotizing enterocolitis (NEC
NEC defined in CNN according to modified Bell's criteria.
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Secondary Outcomes (4)
Survival
From date of randomization until the date of 34 weeks corrected gestational age
Late-onset sepsis
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Growth anthropometrics at 36 weeks corrected gestation
at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Other Outcomes (1)
Probiotic sepsis
birth to discharge from level III NICU or 34 weeks corrected age whichever comes first
Study Arms (2)
Control
NO INTERVENTIONInfants will not receive any probiotics.
Multi-strain probiotics
EXPERIMENTALInfants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.
Interventions
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
Eligibility Criteria
You may qualify if:
- Infants born between \<32 0/7 weeks gestation.
You may not qualify if:
- Major congenital or chromosomal abnormalities
- Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Foothills Medical Center
Calgary, Alberta, T2Z 2G9, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Children's and Women's health of Britch Columbia
Vancouver, British Columbia, Canada
IWK
Halifax, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 20, 2025
First Posted
February 5, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
May 30, 2028
Last Updated
February 5, 2025
Record last verified: 2025-01