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

No Placebo-Only Group

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.

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.

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

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I am between 1 and 17 years old.

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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:

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I am taking medication to control my blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to initiation of enteral tube feeds then on day 1, day 5-7, and day 14 of feedings

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.