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Search / Trial NCT03414775

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

Launched by UNIVERSITY OF PITTSBURGH · Jan 22, 2018

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Microbiome Gastrointestinal Microbiome Pediatrics Critical Illness

ClinConnect Summary

This clinical trial is looking at how two different types of nutritional formulas, Pediasure and Nourish, affect the gut health of critically ill children. The study aims to see which formula is better at helping the gut microbiome, which is the group of bacteria that live in our digestive system and play an important role in our overall health. Children between the ages of 1 and 17 who are admitted to the pediatric intensive care unit and have a special feeding tube in place may be eligible to participate.

Participants will be randomly assigned to receive either Pediasure or Nourish during the trial. It's important to note that children who are currently using certain medications, have specific allergies or intolerances to the formulas, or have medical conditions requiring special diets cannot participate. If enrolled, families can expect to contribute to valuable research that could help improve nutrition for critically ill children in the future.

Gender

ALL

Eligibility criteria

  • 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)

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Raj Aneja, MD

Principal Investigator

University of Pittsburgh Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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