Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Phase 1

Recruiting

• Conditions: Acute Gastroenteritis
• Interventions: Dietary Supplement: Standard of Care Oral Rehydration Therapy; Drug: Fortified Oral Rehydration Therapy

• Registration Number: NCT06137014
• Lead Sponsor: Paul A Breslin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-18
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care oral rehydration therapy	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)
Amino acid-fortified oral rehydration therapy	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)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States