CompletedNot Applicable

Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children

United States32 participantsStarted 2018-02-02

Plain-language summary

This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.

Who can participate

Age range1 Year – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to the pediatric intensive care unit * Age 1-17 years old * Previously placed enteric tube designed for enteric feeding Exclusion Criteria: * Vasoactive medication use * History of allergies or intolerances to either Pediasure or Nourish * Whey allergy or intolerance * Gluten sensitivity or intolerance * Medical condition that necessitate the use of specific formulas and/or nutritional needs (e.g. epilepsy requiring ketogenic diet, genetic metabolic dysfunction with specific formula requirements)

What they're measuring

Changes to the gastrointestinal microbiome

Timeframe: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Changes to the gastrointestinal microbiome

Timeframe: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Trial details

NCT IDNCT03414775

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01

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