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

University of Pittsburgh

Status: Completed

Conditions: Dysbiosis; Critical Illness; Pediatric ALL

Treatments: Other: Nourish; Other: Pediasure

Study type: Interventional

Funder types: Other

Identifiers

NCT03414775

STUDY19080289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Pediasure

Active Comparator group

Description:

Patients assigned to this arm will receive Pediasure

Treatment:

Other: Pediasure

Nourish

Active Comparator group

Description:

Patients assigned to this arm will receive Nourish

Treatment:

Other: Nourish