Study the Safety and Efficacy of Probiotics Use in Premature Infants

Overview

Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
  • Study Primary Completion Date: December 2016

Interventions

  • Dietary Supplement: breast milk with Bifidobacterium Longum subp. Infantis R0033
  • Dietary Supplement: breast milk

Clinical Trial Outcome Measures

Primary Measures

  • Calprotectin will be used to determine the effect for probiotics
    • Time Frame: day1 and day30 of the observation

Participating in This Clinical Trial

Inclusion Criteria

  • born with weight<1500 g – hospitalized within 48 hours after birth Exclusion Criteria:

  • present with evidence or suspicion of congenital intestinal obstruction – perforation – gastroschisis – large omphalocele – congenital diaphragmatic hernia – major congenital heart defects

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Collaborator
    • Lallemand Health Solutions
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. James Friel, Professor – University of Manitoba

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