Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Description

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

Study Overview

Study Details

Study overview

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.

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

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Condition
Acute Gastroenteritis
Intervention / Treatment

-

Contacts and Locations

New Brunswick

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08901

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Between the ages of 6 months and 5 years.
  • * Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
  • * Diarrhea presumed infectious
  • * Severe gastroenteritis with moderate to severe dehydration
  • * Requiring inpatient care
  • * Requiring antibiotics
  • * Requiring IV rehydration
  • * History of chronic diarrhea
  • * Presenting with diarrhea for greater than 2 days prior to admission
  • * Allergy to any of the ingredients in the study products
  • * Inborn metabolic disorder of amino acids
  • * Receives post-pyloric feedings

Ages Eligible for Study

6 Months to 5 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Paul A Breslin,

Paul Breslin, PhD, PRINCIPAL_INVESTIGATOR, Rutgers, The State University of New Jersey

Study Record Dates

2026-07