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Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
Who can join
6 Months – 5 Years · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Fortified Oral Rehydration Therapy (drug)
- Standard of Care Oral Rehydration Therapy (dietary supplement)
Sponsor: Paul A Breslin · Participants: 72 · Started: Jun 1, 2024
Contact the study team
- Paul Breslin, PhD · Phone: (848) 932-6085
- Payton Harmon · Phone: 978-944-8484
Official record on ClinicalTrials.gov — NCT06137014
Locations in the U.S.
| New Jersey | Robert Wood Johnson University Hospital, New Brunswick |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.