drugset / Trial / NCT06137014
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
RandomizedParallel-groupTriple-blindTreatment
Summary
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.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2026-12
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fortified Oral Rehydration Therapy | Unknown | 50 ml | Oral |
| Subject | Fortified Oral Rehydration Therapy | Unknown | 100 ml | Oral |
| Subject | Fortified Oral Rehydration Therapy | Unknown | 200 ml | Oral |