What this study is
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.
What's being tested
- Fortified Oral Rehydration Therapy
Intervention · DRUG
Oral rehydration solution with reduced glucose and added amino acids.
- Standard of Care Oral Rehydration Therapy
Intervention · DIETARY SUPPLEMENT
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Study details
- Official title
- Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
- Sponsor
- Paul A Breslin
- Conditions
- Acute Gastroenteritis
- Enrolling
- 72 people
- Starts
- 2024-06-01
- Est. completion
- 2026-07
- Design
- Triple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Months – 5 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRobert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
- Paul AS Breslin, PhD · Contact848-932-6080pasb@sebs.rutgers.edu
- Payton Harmon, BS · Contact978-944-8484payton.harmon@rutgers.edu
Recruiting
Study team
Sponsor
Paul A Breslin
Study ID Pro2021002499
Principal investigator
Paul Breslin, PhD
Rutgers, The State University of New Jersey
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.