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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:1 - 17
Updated:3/10/2019
Start Date:February 2, 2018
End Date:December 2019
Contact:Justin Azar, MD
Email:justin.azar@chp.edu
Phone:412-692-5833

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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.

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.

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)
We found this trial at
1
site
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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