Acute Gastroenteritis Clinical Trial
— fORTOfficial title:
Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | July 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 5 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Paul A Breslin | The Gerber Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily Stool Frequency | Number of bowel movements (BMs) per day (count) | Up to 14 days | |
Primary | Daily Stool Mass | Total mass of stool per day from measured BMs in grams | Up to 14 days | |
Primary | Duration of Diarrhea | Duration of diarrhea in hours from onset until 3 formed stools in a row | Up to 14 days | |
Secondary | Consumption of Study Intervention | Mls of ORT or FORT consumed per day | Up to 14 days | |
Secondary | Stool Consistency | Stool consistency rated on the Bristol Stool Scale | Up to 14 days | |
Secondary | Body Weight | Weight of child each day of study in kg | Up to 14 days | |
Secondary | Stool Human Beta-Defensin-2 Content | Beta-defensin-2 measured from stool sample in ng/ml | Up to 14 days |
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