Critical Illness, Dysbiosis, Pediatric ALL
Conditions
Keywords
microbiome, gastrointestinal microbiome, pediatrics, critical illness
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.
Interventions
OTHERNourish
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
OTHERPediasure
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes to the gastrointestinal microbiome | Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings | Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of short-chain fatty acids | Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings | Fecal samples will be analyzed by gas chromatography |
Countries
United States
Outcome results
None listed