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Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Recruiting
6 - 5 years of age
Both
Phase 1/2

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Overview

The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are:

  • can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?
  • can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT?

Participants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.

Eligibility

Inclusion Criteria:

  • Between the ages of 6 months and 5 years.
  • Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
  • Diarrhea presumed infectious

Exclusion Criteria:

  • Severe gastroenteritis with moderate to severe dehydration
  • Requiring inpatient care
  • Requiring antibiotics
  • Requiring IV rehydration
  • History of chronic diarrhea
  • Presenting with diarrhea for greater than 2 days prior to admission
  • Allergy to any of the ingredients in the study products
  • Inborn metabolic disorder of amino acids
  • Receives post-pyloric feedings

Study details

Acute Gastroenteritis

NCT06137014

Paul A Breslin

15 June 2024

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