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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 5
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
Contact Information
Primary
Paul Breslin, PhD
breslin@monell.org
(848) 932-6085
Backup
Payton Harmon
payton.harmon@rutgers.edu
978-944-8484
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 72
Treatments
Experimental: Amino acid-fortified oral rehydration therapy
Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the World Health Organization (WHO) Treatment Plan A for ORT administration:~* Child under 24 months: 50 to 100 ml ORT after each loose stool (approximately 500 ml daily)~* Child from 2 to 10 years: 100 to 200 ml ORT after each loose stool (approximately 1000 ml daily)
Placebo_comparator: Standard of care oral rehydration therapy
Participants will consume the standard of care oral rehydration therapy according to the WHO Treatment Plan A for ORT administration:~* Child under 24 months: 50 to 100 ml after each loose stool (approximately 500 ml daily)~* Child from 2 to 10 years: 100 to 200 ml after each loose stool (approximately 1000 ml daily)
Related Therapeutic Areas
Sponsors
Leads: Paul A Breslin
Collaborators: The Gerber Foundation

This content was sourced from clinicaltrials.gov