RECRUITING

Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-01
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06137014

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.

Ages Eligible for Study:6 Months to 5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 6 months and 5 years.
  2. * Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
  3. * Diarrhea presumed infectious
  1. * Severe gastroenteritis with moderate to severe dehydration
  2. * Requiring inpatient care
  3. * Requiring antibiotics
  4. * Requiring IV rehydration
  5. * History of chronic diarrhea
  6. * Presenting with diarrhea for greater than 2 days prior to admission
  7. * Allergy to any of the ingredients in the study products
  8. * Inborn metabolic disorder of amino acids
  9. * Receives post-pyloric feedings

Contacts and Locations

Study Contact

Paul Breslin, PhD
CONTACT
(848) 932-6085
breslin@monell.org
Payton Harmon
CONTACT
978-944-8484
payton.harmon@rutgers.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Paul A Breslin

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-06-01
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Gastroenteritis
  • Intestinal Diseases
  • Pediatric Diseases
  • Diarrhea, Infantile

Additional Relevant MeSH Terms

  • Acute Gastroenteritis