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High-Fiber Formula for Gut Health in Critically Ill Children

N/A
Recruiting
Led By Raj Aneja, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 1-17 years old
Admitted to the pediatric intensive care unit
Must not have
Vasoactive medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
Awards & highlights

Summary

This trial will study whether two different types of formula have different effects on the gut microbiome of critically ill children.

Who is the study for?
This trial is for critically ill children aged 1-17 who are in the pediatric intensive care unit and have a tube placed for feeding. It's not suitable for those on heart medications, with allergies to Pediasure or Nourish, whey/gluten sensitivities, or special dietary needs due to conditions like epilepsy.Check my eligibility
What is being tested?
The study compares the effects of two different formulas—Pediasure and Nourish—on the gut bacteria of sick kids. Children will be randomly assigned to receive one of these formulas through their feeding tubes.See study design
What are the potential side effects?
Potential side effects may include digestive issues such as upset stomach, diarrhea, or constipation related to formula intolerance. Allergic reactions could occur if there's an unknown allergy to ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 1 and 17 years old.
Select...
My child is currently in the pediatric intensive care unit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking medication to control my blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes to the gastrointestinal microbiome
Secondary outcome measures
Concentration of short-chain fatty acids

Trial Design

2Treatment groups
Active Control
Group I: PediasureActive Control1 Intervention
Patients assigned to this arm will receive Pediasure
Group II: NourishActive Control1 Intervention
Patients assigned to this arm will receive Nourish

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,737 Previous Clinical Trials
16,339,217 Total Patients Enrolled
13 Trials studying Critical Illness
7,830 Patients Enrolled for Critical Illness
Raj Aneja, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center

Media Library

Nourish (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03414775 — N/A
Critical Illness Research Study Groups: Pediasure, Nourish
Critical Illness Clinical Trial 2023: Nourish Highlights & Side Effects. Trial Name: NCT03414775 — N/A
Nourish (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03414775 — N/A
~3 spots leftby Feb 2025
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