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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414775
• Other study ID #: STUDY19080289
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Justin Azar, MD
• Phone: 412-692-5833
• Email: justin.azar[@]chp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Dysbiosis
• Pediatric ALL

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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