Status:
RECRUITING
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Lead Sponsor:
Paul A Breslin
Collaborating Sponsors:
The Gerber Foundation
Conditions:
Acute Gastroenteritis
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06137014
Start Date
June 1 2024
End Date
July 1 2026
Last Update
June 10 2024
Active Locations (1)
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1
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901