Clinical trial NCT03414775: Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
Official title: Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Dysbiosis
Pediatric ALL
Keywords: microbiome
gastrointestinal microbiome
pediatrics
critical illness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes to the gastrointestinal microbiome
timeFrame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
measure: Changes to the gastrointestinal microbiome
timeFrame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Secondary outcomes:
measure: Concentration of short-chain fatty acids
timeFrame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Raj Aneja, MD
role: PRINCIPAL_INVESTIGATOR
References: