Actively Recruiting
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Led by Paul A Breslin · Updated on 2026-02-12
72
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
P
Paul A Breslin
Lead Sponsor
T
The Gerber Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
P
Paul Breslin, PhD
CONTACT
P
Payton Harmon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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