Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Recruiting now · Phase 1/Phase 2

Conditions studied: Acute Gastroenteritis

In brief

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.

Key facts

Study ID

NCT06137014

Run by

Paul A Breslin

People needed

72

Starts

2024-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-02-12

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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