Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Acute Gastroenteritis Clinical Trial

— fORT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06137014
• Other study ID #: Pro2021002499
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2023
• Est. completion date: July 2026

Study information

• Verified date: November 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Paul Breslin, PhD
• Phone: (848) 932-6085
• Email: breslin[@]monell.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: July 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion 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

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

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

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Paul Breslin, PhD	The Gerber Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Stool Frequency	Number of bowel movements (BMs) per day (count)	Up to 14 days
Primary	Daily Stool Mass	Total mass of stool per day from measured BMs in grams	Up to 14 days
Primary	Duration of Diarrhea	Duration of diarrhea in hours from onset until 3 formed stools in a row	Up to 14 days
Secondary	Consumption of Study Intervention	Mls of ORT or FORT consumed per day	Up to 14 days
Secondary	Stool Consistency	Stool consistency rated on the Bristol Stool Scale	Up to 14 days
Secondary	Body Weight	Weight of child each day of study in kg	Up to 14 days
Secondary	Stool Human Beta-Defensin-2 Content	Beta-defensin-2 measured from stool sample in ng/ml	Up to 14 days