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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414775
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Rajesh Aneja, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Critical Illness Dysbiosis Pediatric ALL Other: Nourish Other: Pediasure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Influences of High-fiber, Organic Whole-food Formula on the Gut Microbiome in Critically Ill Children
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pediasure
Patients assigned to this arm will receive Pediasure
Other: Pediasure
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome

Active Comparator: Nourish
Patients assigned to this arm will receive Nourish
Other: Nourish
The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome




Primary Outcome Measures :
  1. Changes to the gastrointestinal microbiome [ Time Frame: 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

  2. Changes to the gastrointestinal microbiome [ Time Frame: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings ]
    Salivary samples will be collected for bacterial 16s rRNA gene sequencing and analysis


Secondary Outcome Measures :
  1. Concentration of short-chain fatty acids [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414775


Contacts
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Contact: Justin Azar, MD 412-692-5833 justin.azar@chp.edu
Contact: Michael Morowitz, MD michael.morowitz@chp.edu

Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Rajesh Aneja, MD       anejar@upmc.edu   
Contact: Justin Azar, MD       justin.azar@chp.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Raj Aneja, MD University of Pittsburgh Medical Center
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Responsible Party: Rajesh Aneja, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03414775    
Other Study ID Numbers: PRO17080103
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajesh Aneja, University of Pittsburgh:
microbiome
gastrointestinal microbiome
pediatrics
critical illness
Additional relevant MeSH terms:
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Critical Illness
Dysbiosis
Disease Attributes
Pathologic Processes