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

Study Overview
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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.

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.

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

Conditions
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Critical Illness, Dysbiosis, Pediatric ALL

Intervention / Treatment
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* Other: Nourish
* Other: Pediasure


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pediasure<br>Patients assigned to this arm will receive Pediasure | Other: Pediasure<br>* The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome<br>|
| Active Comparator: Nourish<br>Patients assigned to this arm will receive Nourish | Other: Nourish<br>* The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, gastrointestinal microbiome, pediatrics, critical illness