Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
Primary Purpose
Critical Illness, Dysbiosis, Pediatric ALL
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nourish
Pediasure
Sponsored by
About this trial
This is an interventional other trial for Critical Illness focused on measuring microbiome, gastrointestinal microbiome, pediatrics, critical illness
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)
Sites / Locations
- Children's Hospital of Pittsburgh of UPMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pediasure
Nourish
Arm Description
Patients assigned to this arm will receive Pediasure
Patients assigned to this arm will receive Nourish
Outcomes
Primary Outcome Measures
Changes to the gastrointestinal microbiome
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Changes to the gastrointestinal microbiome
Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Secondary Outcome Measures
Concentration of short-chain fatty acids
Fecal samples will be analyzed by gas chromatography
Full Information
NCT ID
NCT03414775
First Posted
January 22, 2018
Last Updated
April 7, 2023
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03414775
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Dysbiosis, Pediatric ALL
Keywords
microbiome, gastrointestinal microbiome, pediatrics, critical illness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediasure
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will receive Pediasure
Arm Title
Nourish
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will receive Nourish
Intervention Type
Other
Intervention Name(s)
Nourish
Intervention Description
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Intervention Type
Other
Intervention Name(s)
Pediasure
Intervention Description
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
Primary Outcome Measure Information:
Title
Changes to the gastrointestinal microbiome
Description
Fecal samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time Frame
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Title
Changes to the gastrointestinal microbiome
Description
Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis
Time Frame
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Secondary Outcome Measure Information:
Title
Concentration of short-chain fatty acids
Description
Fecal samples will be analyzed by gas chromatography
Time Frame
Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Azar, MD
Phone
412-692-5833
Email
justin.azar@chp.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Morowitz, MD
Email
michael.morowitz@chp.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raj Aneja, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh Aneja, MD
Email
anejar@upmc.edu
First Name & Middle Initial & Last Name & Degree
Justin Azar, MD
Email
justin.azar@chp.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
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