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High-Fiber Formula for Gut Health in Critically Ill Children

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
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

Study 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
I am between 1 and 17 years old.
My child is currently in the pediatric intensive care unit.


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
1,731 Previous Clinical Trials
16,307,396 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently accepting individuals for participation?

"The clinical trial is currently accepting participants, according to details available on clinicialtrials.gov. Originally posted on February 2nd 2018, the study was last updated September 19th 2022."

Answered by AI

How many individuals are being admitted to the trial's cohort?

"Affirmative. According to the information hosted on clinicaltrials.gov, this clinical trial is currently recruiting participants and was initially posted on February 2nd 2018. Up until September 19th 2022, 40 individuals from 1 location have been accepted into the study."

Answered by AI

What criteria must be met to qualify as a participant in this research study?

"To be eligible for inclusion in this clinical study, potential participants must have a severe illness and fall between 1 year old and 17 years old. The aim of the trial is to recruit 40 patients."

Answered by AI

Does the research allow for geriatric populations to join?

"This clinical trial requires participants to be aged 1 year up to 17 years. Out of the 221 different trials, 49 are specific for those below 18 and 172 target patients over 65."

Answered by AI
~4 spots leftby Feb 2025