NCT06137014

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Paul A Breslin · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-11-18
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study