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

NCT06810154 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2170

Last updated 2025-02-05

No results posted yet for this study

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?

Conditions

  • Necrotizing Enterocolitis (NEC)

Interventions

BIOLOGICAL

Multi-strain probiotics

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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
0 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-05-30
Completion
2028-05-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06810154 on ClinicalTrials.gov