NCT06137014PHASE1, PHASE2Recruiting

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Paul A Breslin

Start Date

6/1/2024

Completion Date

6/1/2027

Summary

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 Criteria

Age Range: No minimum to 5 years

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

Interventions

DRUG

Fortified Oral Rehydration Therapy

DIETARY_SUPPLEMENT

Standard of Care Oral Rehydration Therapy

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Conditions

Acute Gastroenteritis

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey 08901

United States