Fortified Oral Rehydration Therapy for Pediatric Diarrhea (fORT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Drug: Fortified Oral Rehydration Therapy; Dietary supplement: Standard of Care Oral Rehydration Therapy

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Paul Breslin, PhD; Phone Number: (848) 932-6085; Email: breslin@monell.org
• Study Contact Backup: Name: Payton Harmon; Phone Number: 978-944-8484; Email: payton.harmon@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amino acid-fortified oral rehydration therapy; Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the 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)	Drug: Fortified Oral Rehydration Therapy; Oral rehydration solution with reduced glucose and added amino acids.; Other Names: FORT
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)	Dietary supplement: Standard of Care Oral Rehydration Therapy; Glucose-based oral rehydration therapy according to World Health Organization guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Stool Frequency	Number of bowel movements (BMs) per day (count)	Up to 14 days
Daily Stool Mass	Total mass of stool per day from measured BMs in grams	Up to 14 days
Duration of Diarrhea	Duration of diarrhea in hours from onset until 3 formed stools in a row	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of Study Intervention	Mls of ORT or FORT consumed per day	Up to 14 days
Stool Consistency	Stool consistency rated on the Bristol Stool Scale	Up to 14 days
Body Weight	Weight of child each day of study in kg	Up to 14 days
Stool Human Beta-Defensin-2 Content	Beta-defensin-2 measured from stool sample in ng/ml	Up to 14 days

Collaborators and Investigators

• Sponsor: Paul Breslin, PhD
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Paul Breslin, PhD, Rutgers, the State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gastroenteritis; Intestinal Diseases; Pediatric Diseases; Diarrhea, Infantile
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: Pro2021002499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share all de-identified data upon request by other researchers upon submission of manuscripts to journals.
• IPD Sharing Time Frame: These will be made available to researchers and editors upon submission of manuscripts to journals for a period of up to 7 years post publication.
• IPD Sharing Access Criteria: Qualified independent researchers with an academic interest in pediatric GI disease. These data will be provided following review and approval of a research proposal, statistical analysis plan, and execution of a data sharing plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No