Fortified Oral Rehydration Therapy for Pediatric Diarrhea

NCT06137014 — Phase 1 / Phase 2, Recruiting, 72 participants, Paul A Breslin

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

Registry	NCT06137014, acronym fORT
Status	Recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	72 (Estimated)
Sponsor	Paul A Breslin (Other); collaborators: The Gerber Foundation
Conditions	Acute Gastroenteritis
Interventions	Fortified Oral Rehydration Therapy, Standard of Care Oral Rehydration Therapy (Drug, dietary supplement)
Dates	start 2024-06-01, primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2023-11-18, last updated 2026-02-12
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Amino acid-fortified oral rehydration therapy	Experimental	Drug: 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)
Standard of care oral rehydration therapy	Placebo comparator	Dietary Supplement: 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)

Fortified Oral Rehydration Therapy (Drug), also known as FORT: Oral rehydration solution with reduced glucose and added amino acids.
Standard of Care Oral Rehydration Therapy (Dietary supplement): Glucose-based oral rehydration therapy according to World Health Organization guidelines.

+Outcome measures

Primary outcomes

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 outcomes

Consumption of Study Intervention [Up to 14 days]: Mls of ORT or FORT consumed per day
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
Stool Human Beta-Defensin-2 Content [Up to 14 days]: Beta-defensin-2 measured from stool sample in ng/ml

+Eligibility

Sex: All, ages: 6 Months to 5 Years

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

+Locations (1)

Facility	City	Country	Status
Robert Wood Johnson University Hospital	New Brunswick, New Jersey	United States	Recruiting

+Investigators

Paul Breslin, PhD, Principal investigator, Rutgers, The State University of New Jersey