Fortified Oral Rehydration Therapy for Pediatric Diarrhea
NCT ID: NCT06137014
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2024-06-01
2027-06-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Amino acid-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)
Fortified Oral Rehydration Therapy
Oral rehydration solution with reduced glucose and added amino acids.
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)
Standard of Care Oral Rehydration Therapy
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Interventions
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Fortified Oral Rehydration Therapy
Oral rehydration solution with reduced glucose and added amino acids.
Standard of Care Oral Rehydration Therapy
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
* Diarrhea presumed infectious
Exclusion Criteria
* 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
6 Months
5 Years
ALL
No
Sponsors
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The Gerber Foundation
OTHER
Paul A Breslin
OTHER
Responsible Party
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Paul A Breslin
Professor of Nutritional Sciences
Principal Investigators
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Paul Breslin, PhD
Role: PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey
Locations
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Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro2021002499
Identifier Type: -
Identifier Source: org_study_id
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