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

University of Calgary

Status and phase: Not yet enrolling; Phase 3

Conditions: Necrotizing Enterocolitis (NEC)

Treatments: Biological: Multi-strain probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06810154

U of Calgary REB24-1960

Details and patient eligibility

About

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?

Full 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.

Enrollment: 2,170 estimated patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,170 participants in 2 patient groups

Control

No Intervention group

Description:

Infants will not receive any probiotics.

Multi-strain probiotics

Experimental group

Description:

Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.

Treatment:

Biological: Multi-strain probiotics