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

NCT03414775 | Completed

• 1 other identifier: STUDY19080289
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 Nourish.

Conditions

Critical Illness; Dysbiosis; Pediatric ALL

Keywords

microbiome; gastrointestinal microbiome; pediatrics; critical illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Concentration of short-chain fatty acids

  Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Study Arms (2)

Pediasure

ACTIVE COMPARATOR

Patients assigned to this arm will receive Pediasure

Other: Pediasure

Nourish

ACTIVE COMPARATOR

Patients assigned to this arm will receive Nourish

Other: Nourish

Interventions

Nourish OTHER

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Nourish

Pediasure OTHER

The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Pediasure

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Admitted to the pediatric intensive care unit
• Age 1-17 years old
• Previously placed enteric tube designed for enteric feeding

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Critical Illness; Dysbiosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Raj Aneja, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Critically-ill children who are medically stable and ready for enteral tube feeds will be randomized to receive either Pediasure or Nourish. Nutritional needs will be calculated per previously established standards at our institution and performed in conjunction with trained dieticians and nutritionists.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 30, 2018
• Study Start: February 2, 2018
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)