Amino acid-fortified oral rehydration for kids with diarrhea
Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
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 |
| Enrollment | 72 (estimated) |
| Ages | 6 Months to 5 Years |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT06137014 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 5 years with mild to moderate acute gastroenteritis lasting less than two days.
Not a fit: Patients with severe gastroenteritis requiring hospitalization or those with chronic diarrhea will not benefit from this study.
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 performed: While similar studies have explored oral rehydration therapies, the specific use of amino acid-fortified ORT in this context is relatively novel.
Eligibility criteria
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 this trial is running
New Brunswick, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.