Skip to main content
OpenTrials
Completed

NCT Number: NCT03414775

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nourish

Other

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Pediasure

Other

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Primary outcomes

  1. Changes to the gastrointestinal microbiome

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

    Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis

  2. Changes to the gastrointestinal microbiome

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

    Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis

Secondary outcomes

  1. Concentration of short-chain fatty acids

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

    Fecal samples will be analyzed by gas chromatography

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2018
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.