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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Dysbiosis; Pediatric ALL
• Intervention / Treatment: Other: Pediasure; Other: Nourish

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 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pediasure; Patients assigned to this arm will receive Pediasure	Other: Pediasure; The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Active Comparator: Nourish; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes to the gastrointestinal microbiome	Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis	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	Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of short-chain fatty acids	Fecal samples will be analyzed by gas chromatography	Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Raj Aneja, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; microbiome; critical illness; gastrointestinal microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Critical Illness; Dysbiosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: STUDY19080289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No