NCT06810154

Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants

Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants: a Stepped-Wedge Cluster Randomized Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,170 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 0 Hours – 72 Hours
• Healthy volunteers: Not accepted

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?

Detailed description

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: * Preterm infants born at \<32 weeks' gestation and \<1500 g birth weight. 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.

Conditions

• Necrotizing Enterocolitis (NEC)

Interventions

Type	Name	Description
BIOLOGICAL	Multi-strain probiotics	Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-05-30
• Completion: 2028-05-30
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

4 sites across 1 country: Canada