Acute Gastroenteritis
Conditions
Keywords
Gastroenteritis, Intestinal Diseases, Pediatric Diseases, Diarrhea, Infantile
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 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.
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.
Sponsors
Paul A Breslin
The Gerber Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
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 * Receives post-pyloric feedings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Stool Frequency | Up to 14 days | Number of bowel movements (BMs) per day (count) |
| Daily Stool Mass | Up to 14 days | Total mass of stool per day from measured BMs in grams |
| Duration of Diarrhea | Up to 14 days | Duration of diarrhea in hours from onset until 3 formed stools in a row |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of Study Intervention | Up to 14 days | Mls of ORT or FORT consumed per day |
| Stool Consistency | Up to 14 days | Stool consistency rated on the Bristol Stool Scale |
| Body Weight | Up to 14 days | Weight of child each day of study in kg |
| Stool Human Beta-Defensin-2 Content | Up to 14 days | Beta-defensin-2 measured from stool sample in ng/ml |
Countries
United States
Contacts
CONTACTPaul Breslin, PhD
CONTACTPayton Harmon
PRINCIPAL_INVESTIGATORPaul Breslin, PhD
Rutgers, The State University of New Jersey
Outcome results
None listed