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Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Study acronym: fORT
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Jul 2026 to Jun 2027
    v3
  2. Lead sponsor: Paul Breslin, PhD to Paul A Breslin
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2023 to Jun 1, 2024
    • Study sites: 0 to 1
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06137014
Lead Sponsor Paul A Breslin
Collaborators: The Gerber Foundation
Conditions
(from sponsor)		 Acute Gastroenteritis
Related terms Diarrhea, Infantile, Gastroenteritis, Intestinal Diseases
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov