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NCT Number: NCT06810154

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

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?

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Key information

Conditions

Necrotizing Enterocolitis (NEC) Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-strain probiotics

Biological

Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Survival

    Time frame: From date of randomization until the date of 34 weeks corrected gestational age

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Belal N Alshaikh, MD, MSc

CONTACT

[email protected]

+1 403 956 1588

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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