Amino acid-fortified oral rehydration for kids with diarrhea
Official title: Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
Run by Rutgers, The State University of New Jersey · NCT06137014 · Data updated 2026-11-12
This study tests if a special rehydration drink with added amino acids can help young children with diarrhea feel better faster than the usual rehydration drink.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months to 5 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06137014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 months to 5 years with mild to moderate acute gastroenteritis lasting less than two days.
✕Probably not a fit
Patients with severe gastroenteritis requiring hospitalization or those with chronic diarrhea will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness of amino acid-fortified oral rehydration therapy (ORT) to standard ORT in children aged 6 months to 5 years suffering from acute gastroenteritis. The study aims to determine if the fortified ORT can reduce the duration and severity of diarrhea and enhance the secretion of antimicrobial peptides in the gastrointestinal tract. Participants will be randomly assigned to receive either the experimental treatment or the standard care, and their health outcomes will be closely monitored.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced severity of diarrhea in pediatric patients.
How similar studies have gone: While similar studies have explored oral rehydration therapies, the specific use of amino acid-fortified ORT in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States Recruiting
Study contacts
- Principal investigator: Paul Breslin, PhD — Rutgers, The State University of New Jersey
- Study coordinator: Paul Breslin, PhD
- Email: breslin@monell.org
- Phone: (848) 932-6085
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.