Fortified Oral Rehydration Therapy for Pediatric Diarrhea

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Gastroenteritis

Intervention / Treatment
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* Drug: Fortified Oral Rehydration Therapy
* Dietary Supplement: Standard of Care Oral Rehydration Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amino acid-fortified oral rehydration therapy<br>Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the 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<br>* Oral rehydration solution with reduced glucose and added amino acids.<br>* Other names: FORT;|
| Placebo Comparator: Standard of care oral rehydration therapy<br>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<br>* Glucose-based oral rehydration therapy according to World Health Organization guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroenteritis, Intestinal Diseases, Pediatric Diseases, Diarrhea, Infantile