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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Oral rehydration solution with reduced glucose and added amino acids.
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RECRUITINGDaily Stool Frequency
Number of bowel movements (BMs) per day (count)
Time frame: Up to 14 days
Daily Stool Mass
Total mass of stool per day from measured BMs in grams
Time frame: Up to 14 days
Duration of Diarrhea
Duration of diarrhea in hours from onset until 3 formed stools in a row
Time frame: Up to 14 days
Consumption of Study Intervention
Mls of ORT or FORT consumed per day
Time frame: Up to 14 days
Stool Consistency
Stool consistency rated on the Bristol Stool Scale
Time frame: Up to 14 days
Body Weight
Weight of child each day of study in kg
Time frame: Up to 14 days
Stool Human Beta-Defensin-2 Content
Beta-defensin-2 measured from stool sample in ng/ml
Time frame: Up to 14 days
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