COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-02-02
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03414775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Admitted to the pediatric intensive care unit
  2. * Age 1-17 years old
  3. * Previously placed enteric tube designed for enteric feeding
  1. * Vasoactive medication use
  2. * History of allergies or intolerances to either Pediasure or Nourish
  3. * Whey allergy or intolerance
  4. * Gluten sensitivity or intolerance
  5. * 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)

Contacts and Locations

Principal Investigator

Raj Aneja, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center

Study Locations (Sites)

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Raj Aneja, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-02
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2018-02-02
Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

  • microbiome
  • gastrointestinal microbiome
  • pediatrics
  • critical illness

Additional Relevant MeSH Terms

  • Critical Illness
  • Dysbiosis
  • Pediatric ALL