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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Dysbiosis Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pediasure

Patients assigned to this arm will receive Pediasure

Group Type ACTIVE_COMPARATOR

Pediasure

Intervention Type OTHER

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

Nourish

Patients assigned to this arm will receive Nourish

Group Type ACTIVE_COMPARATOR

Nourish

Intervention Type OTHER

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

Interventions

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Nourish

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

Intervention Type OTHER

Pediasure

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No