NCT06137014 · Paul A Breslin
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
(fORT)
What this study is about
The goal of this clinical trial is to compare amino acid-fortified taken by mouth rehydration therapy (ORT) to the the usual treatment ORT in pediatric patients with acute gastroenteritis (AGE).
View original scientific description
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
Number of bowel movements (BMs) per day (count)
Daily Stool Mass
Time frame: Up to 14 days
Total mass of stool per day from measured BMs in grams
Duration of Diarrhea
Time frame: Up to 14 days
Duration of diarrhea in hours from onset until 3 formed stools in a row
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Brunswick, New Jersey
Collaborators
The Gerber Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations