Fortified Oral Rehydration Therapy for Pediatric Diarrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fortified Oral Rehydration Therapy, Standard of Care Oral Rehydration Therapy.
- Who it may be relevant to
- Registry conditions: Acute Gastroenteritis. Basic parameters: 6 months — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
Overview
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
- Drug Fortified Oral Rehydration Therapy
Oral rehydration solution with reduced glucose and added amino acids. - Dietary supplement Standard of Care Oral Rehydration Therapy
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Primary outcome measures
- Daily Stool Frequency [Time frame: Up to 14 days]
- Daily Stool Mass [Time frame: Up to 14 days]
- Duration of Diarrhea [Time frame: Up to 14 days]
Secondary outcome measures (4)
- Consumption of Study Intervention [Time frame: Up to 14 days]
- Stool Consistency [Time frame: Up to 14 days]
- Body Weight [Time frame: Up to 14 days]
- Stool Human Beta-Defensin-2 Content [Time frame: Up to 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Robert Wood Johnson University Hospital — New Brunswick
Identifiers
NCT: NCT06137014 · Pro2021002499