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

Critical Illness Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03414775
Study type Interventional
Source University of Pittsburgh
Contact Justin Azar, MD
Phone 412-692-5833
Email justin.azar@chp.edu
Status Recruiting
Phase N/A
Start date February 2, 2018
Completion date August 2025
View Details
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