Status:
RECRUITING
Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
Lead Sponsor:
University of Pittsburgh
Conditions:
Critical Illness
Dysbiosis
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief 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 Nour...
Detailed 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...
Eligibility Criteria
Inclusion
- Admitted to the pediatric intensive care unit
- Age 1-17 years old
- Previously placed enteric tube designed for enteric feeding
Exclusion
- 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)
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03414775
Start Date
February 2 2018
End Date
August 1 2027
Last Update
February 5 2025
Active Locations (1)
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1
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224