An interventional study of Nourish and Pediasure in Critical Illness, Dysbiosis and Pediatric ALL, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
Patients assigned to this arm will receive Pediasure
Other: Pediasure
Patients assigned to this arm will receive Nourish
Other: Nourish
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Changes to the gastrointestinal microbiome
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Changes to the gastrointestinal microbiome
Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Concentration of short-chain fatty acids
Fecal samples will be analyzed by gas chromatography
Time frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Plan to share: No
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh