A Phase 3 interventional study of Multi-strain probiotics in Necrotizing Enterocolitis (NEC), sponsored by University of Calgary. Not yet recruiting at 4 sites in Canada. Open to participants aged 0 Hours to 72 Hours. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by University of Calgary · Phase 3, Interventional, and Prevention
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:
Researchers will compare outcomes between two phases:
Control Phase: No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates.
Intervention Phase: Participants will receive a daily multi-strain probiotic combination (0.5 g sachet) starting within 24 hours of enteral feeding initiation.
Participants will be:
The study uses a stepped-wedge cluster randomized trial (SW-CRT) design, where neonatal intensive care units (NICUs) transition from the control phase to the intervention phase at pre-specified intervals. Individual consent will be obtained for probiotic administration and data collection during the intervention phase, and data collection-only consent will be sought during the control phase.
This trial is designed to provide high-quality evidence on the efficacy and safety of probiotics in preventing NEC in preterm infants.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 2,170 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Infants will not receive any probiotics.
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.
Biological: Multi-strain probiotics
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
Incidence of necrotizing enterocolitis (NEC
NEC defined in CNN according to modified Bell's criteria.
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Survival
Time frame: From date of randomization until the date of 34 weeks corrected gestational age
Late-onset sepsis
Culture proven late onset sepsis
Time frame: 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
Z scores of weight and head circumference
Time frame: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
Defined by reaching 140 mL/kg/day sustained for three consecutive days
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Probiotic sepsis
Culture proven sepsis by one of the probiotics products
Time frame: birth to discharge from level III NICU or 34 weeks corrected age whichever comes first
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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