Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Last updated: June 6, 2024
Sponsor: Paul A Breslin
Overall Status: Active - Recruiting

Phase

1/2

Condition

Gastroenteritis

Treatment

Fortified Oral Rehydration Therapy

Standard of Care Oral Rehydration Therapy

Clinical Study ID

NCT06137014
Pro2021002499
  • Ages 6-5
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between the ages of 6 months and 5 years.

  • Experiencing mild to moderate acute gastroenteritis for less than two (2) daysbefore admission to Pediatric Emergency Department.

  • Diarrhea presumed infectious

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Fortified Oral Rehydration Therapy
Phase: 1/2
Study Start date:
June 01, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

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