A Phase 1/2 interventional study of Fortified Oral Rehydration Therapy and Standard of Care Oral Rehydration Therapy in Acute Gastroenteritis, sponsored by Paul A Breslin. Recruiting at 1 site in United States. Open to participants aged 6 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Paul A Breslin · Phase 1/2, Interventional, and Treatment
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:
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's planned enrollment of 72 is below the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →This is the only study on the registry with Paul A Breslin as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
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
Oral rehydration solution with reduced glucose and added amino acids.
Also known as: FORT
Glucose-based oral rehydration therapy according to World Health Organization guidelines.
Daily Stool Frequency
Number of bowel movements (BMs) per day (count)
Time frame: Up to 14 days
Daily Stool Mass
Total mass of stool per day from measured BMs in grams
Time frame: Up to 14 days
Duration of Diarrhea
Duration of diarrhea in hours from onset until 3 formed stools in a row
Time frame: Up to 14 days
Consumption of Study Intervention
Mls of ORT or FORT consumed per day
Time frame: Up to 14 days
Stool Consistency
Stool consistency rated on the Bristol Stool Scale
Time frame: Up to 14 days
Body Weight
Weight of child each day of study in kg
Time frame: Up to 14 days
Stool Human Beta-Defensin-2 Content
Beta-defensin-2 measured from stool sample in ng/ml
Time frame: Up to 14 days
Plan to share: Yes — We will share all de-identified data upon request by other researchers upon submission of manuscripts to journals.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
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