Fortified Oral Rehydration Therapy for Pediatric Diarrhea

NCT06137014 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro2021002499
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Gastroenteritis

Keywords

Gastroenteritis; Intestinal Diseases; Pediatric Diseases; Diarrhea, Infantile

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Consumption of Study Intervention

  Up to 14 days

• Stool Consistency

  Up to 14 days

• Body Weight

  Up to 14 days

• Stool Human Beta-Defensin-2 Content

  Up to 14 days

Study Arms (2)

Amino acid-fortified oral rehydration therapy

EXPERIMENTAL

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)

Drug: Fortified Oral Rehydration Therapy

Standard of care oral rehydration therapy

PLACEBO COMPARATOR

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

Interventions

Fortified Oral Rehydration Therapy DRUG

Oral rehydration solution with reduced glucose and added amino acids.

Also known as: FORT

Amino acid-fortified oral rehydration therapy

Standard of Care Oral Rehydration Therapy DIETARY_SUPPLEMENT

Glucose-based oral rehydration therapy according to World Health Organization guidelines.

Standard of care oral rehydration therapy

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul A Breslin: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Gastroenteritis; Intestinal Diseases; Diarrhea, Infantile

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Breslin, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Breslin, PhD

CONTACT

(848) 932-6085; breslin@monell.org

Payton Harmon

CONTACT

978-944-8484; payton.harmon@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Nutritional Sciences

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (1)