Fortified Oral Rehydration Therapy for Pediatric Diarrhea

• Status: Recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul A Breslin
• Collaborator: The Gerber Foundation

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