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RECRUITING
NCT06137014
PHASE1/PHASE2

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Sponsor: Paul A Breslin

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Months - 5 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-06-01

Completion Date

2027-06

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

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.

Locations (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States