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

January 30, 2025 updated by: Belal Alshaikh, University of Calgary

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

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2Z 2G9
        • Foothills Medical Center
        • Contact:
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital
        • Contact:
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Children's and Women's health of Britch Columbia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Infants will not receive any probiotics.
Experimental: Multi-strain 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of necrotizing enterocolitis (NEC
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: From date of randomization until the date of 34 weeks corrected gestational age
From date of randomization until the date of 34 weeks corrected gestational age
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
Culture proven 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
Time Frame: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Z scores of weight and head circumference
at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
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
Defined by reaching 140 mL/kg/day sustained for three consecutive days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probiotic sepsis
Time Frame: birth to discharge from level III NICU or 34 weeks corrected age whichever comes first
Culture proven sepsis by one of the probiotics products
birth to discharge from level III NICU or 34 weeks corrected age whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U of Calgary REB24-1960

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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