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

Not Applicable

Recruiting

• Conditions: Dysbiosis; Critical Illness; Pediatric ALL
• Interventions: Other: Nourish; Other: Pediasure

• Registration Number: NCT03414775
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-30
• Study Start: 2018-02-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2027-02-01
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nourish	Nourish	Patients assigned to this arm will receive Nourish
Pediasure	Pediasure	Patients assigned to this arm will receive Pediasure

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Fecal samples will be analyzed by gas chromatography

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States