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Fortified Oral Rehydration Therapy for Pediatric Diarrhea

RecruitingPhase 1, Phase 2Ages 6 Months - 5 YearsAllPaul A Breslin
NCT06137014 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Fortified Oral Rehydration Therapy
  • Standard of Care Oral Rehydration Therapy
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Where

1 site
Robert Wood Johnson University Hospital
New Brunswick, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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