CompletedNot Applicable

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

United States32 participantsStarted 2018-02-02

Plain-language 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.

Who can participate

Age range

1 Year – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes to the gastrointestinal microbiome

Timeframe: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Changes to the gastrointestinal microbiome

Timeframe: Prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

Trial details

NCT IDNCT03414775

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More Critical Illness trials

Who can participate

Age range

1 Year – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.