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Human-derived Human Milk Fortifiers (H2MF), Gut Microbiota and Oxidative Stress in Premature Infants

NCT03214822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-09-30

No results posted yet for this study

Summary

This is a randomized controlled trial of a human-derived human milk fortifier (H2MF) vs standard bovine-derived human milk fortifier (HMF) evaluating fecal microbiota and fecal and urinary biomarkers of oxidative stress in premature infants.

Conditions

  • Very Low Birth Weight Baby
  • Premature Birth
  • Microbial Colonization
  • Oxidative Stress

Interventions

DIETARY_SUPPLEMENT

H2MF

As described in the Experimental Arm description.

Sponsors & Collaborators

  • Manitoba Developmental Origins of Chronic Diseases in Children Network (DEVOTION)

    collaborator UNKNOWN

  • Prolacta Bioscience

    collaborator INDUSTRY

  • Children's Hospital Foundation

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Meghan Azad, PhD · University of Manitoba

  • Geert T'Jong · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-07-30
Completion
2019-07-30

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 NCT03214822 on ClinicalTrials.gov