drugset / Trial / NCT06137014

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

NCT06137014 ↗

Phase 1/2 Recruiting 72 enrolled Paul A Breslin The Gerber Foundation · collab
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

EvaluationDrugModalityDoseRoute
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

Indications