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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid-fortified oral rehydration therapy | Experimental | Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the World Health Organization (WHO) Treatment Plan A for ORT administration:
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| Standard of care oral rehydration therapy | Placebo Comparator | Participants will consume the standard of care oral rehydration therapy according to the WHO Treatment Plan A for ORT administration:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified Oral Rehydration Therapy | Drug | Oral rehydration solution with reduced glucose and added amino acids. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Breslin, PhD | Contact | (848) 932-6085 | breslin@monell.org | |
| Payton Harmon | Contact | 978-944-8484 | payton.harmon@rutgers.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Breslin, PhD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | Recruiting | New Brunswick | New Jersey | 08901 | United States |
We will share all de-identified data upon request by other researchers upon submission of manuscripts to journals.
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.
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.
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D007410 | Intestinal Diseases |
| D003968 | Diarrhea, Infantile |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003967 | Diarrhea |
| D012817 | Signs and Symptoms, Digestive |
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| Standard of Care Oral Rehydration Therapy | Dietary Supplement | Glucose-based oral rehydration therapy according to World Health Organization guidelines. |
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |