Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
Paul A Breslin
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.
Eligibility
- Age range
- 0–5 years
- Sex
- All
- Healthy volunteers
- No
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 * Receive…
Interventions
- DrugFortified Oral Rehydration Therapy
Oral rehydration solution with reduced glucose and added amino acids.
- Dietary SupplementStandard of Care Oral Rehydration Therapy
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Location
- Robert Wood Johnson University HospitalNew Brunswick, New Jersey