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

Recruiting
1 - 17 years of age
Both
Phase N/A

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Overview

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.

Description

The gastrointestinal microbiome has been shown to be altered in critically-ill children such that there is a larger shift toward pathogenic bacteria. Previous studies have shown that probiotics, fecal transplants, antibiotic decontamination, and dietary interventions can shift the gastrointestinal microbiome toward a metabolically favorable microbiome profile and be associated with improvements in disease burden.

This study will randomize critically-ill children who are stable enough for enteral tube feedings to receive either Pediasure or Nourish. Pediasure is a commercially-made formula that is used commonly in pediatric patients. Nourish is an organic, whole-food formula with a high fiber content. High-fiber diets have been correlated with metabolically favorable microbiome profiles. This study will look at the microbiome before and after initiation of enteral tube feedings to determine if either formula is associated with a shift in the microbiome toward a favorable profile.

Eligibility

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)

Study details

Critical Illness, Dysbiosis, Pediatric ALL

NCT03414775

University of Pittsburgh

31 March 2025

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