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

Phase 3

Not yet recruiting

• Conditions: Necrotizing Enterocolitis (NEC)
• Interventions: Biological: Multi-strain probiotics

• Registration Number: NCT06810154
• Lead Sponsor: University of Calgary

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?

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Study Start: 2025-06-01
• Primary Completion: 2027-05-30
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2170

Inclusion Criteria

• Infants born between <32 0/7 weeks gestation.

Exclusion Criteria

• Major congenital or chromosomal abnormalities
• Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multi-strain probiotics	Multi-strain probiotics	Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.

Primary Outcome Measures

Name	Time	Method
Incidence of necrotizing enterocolitis (NEC	From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first	NEC defined in CNN according to modified Bell's criteria.

Secondary Outcome Measures

Name	Time	Method
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	Culture proven late onset sepsis
Growth anthropometrics at 36 weeks corrected gestation	at 36 weeks corrected age or discharge from level III NICU whichever occure first.	Z scores of weight and head circumference
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	Defined by reaching 140 mL/kg/day sustained for three consecutive days

Trial Locations

Locations (4)

IWK; 🇨🇦 Halifax, Canada

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Children's and Women's health of Britch Columbia; 🇨🇦 Vancouver, British Columbia, Canada