Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution

Study Overview
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Brief Summary
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This is a randomised, controlled, open-label study to determine the clinical effectiveness and safety of a novel ORS compared with a commercial ORS in children 1 to 5 years of age attending emergency departments with gastroenteritis.

Official Title
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Clinical Effectiveness and Safety of a Novel Oral Rehydration Solution in Children Ages 1-5 Years Presenting to Hospital With Mild or Moderate Dehydration Gastroenteritis: Randomized, Open-label, Controlled Trial

Conditions
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Gastroenteritis Acute

Intervention / Treatment
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* Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)
* Dietary Supplement: Sugar free - amino acid and electrolyte ORS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 to 5 years of age, inclusive at randomization Hospitalized with mild to moderate dehydration due to ongoing diarrhea Signed informed consent obtained for child's participation in the study Exclusion Criteria: Severe dehydration and/or use of IV fluids for current hospitalization Experiencing bloody diarrhea or diarrhea due to Cholera, Dysentery, persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated with recent antibiotic use In the opinion of the Investigator, not suitable for treatment with ORS Have any underlying disease or disorder that may, in the opinion of the Investigator, affect the results of the study if they were enrolled (includes, but is not limited to, gastrointestinal disorders such as Crohn's disease or other inflammatory bowel disease or congenital malabsorption disorders) Cause of the dehydration is something other than diarrhea Known to be allergic to any of the components of the Investigational ORS

Ages Eligible for Study
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Minimum Age: 1 Year
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Commercial reduced-osmolarity oral rehydration solution (ORS<br> | Dietary Supplement: Glucose containing Oral Rehydration Solution (ORS)<br>* Oral rehydration solution<br>|
| Experimental: VS011, new children's ORS, a sugar-free blend of amino acids and electrolytes<br> | Dietary Supplement: Sugar free - amino acid and electrolyte ORS<br>* Glucose free oral rehydration solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically assessed adequate rehydration based on clinical judgement of change in or absence of presenting symptoms from baseline (i.e. heart rate, urine output, etc.) | Assess change in clinical hydration status from presenting baseline status | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Assessment of patient's hydration status based on presenting symptoms (i.e. heart rate, urine output, etc.) | 5 point scale, 1(no discomfort) minimum, 5 (severe discomfort) maximum | Baseline | 
| Study ORS intake (units) |  | Every 4 hours up to 24 hours or hospital discharge, whichever occurs first | 
| Use of IV fluids |  | up to 24 hours or hospital discharge, whichever occurs first | 
| Weight | kg | Every 4 hours up to 24 h or at hospital discharge, whichever occurs first | 
| Participant comfort questionaire |  | baseline and 24 hours or hospital discharge, whichever occurs first | 
| Parent satisfaction questionnaire |  | baseline and 24 hours or hospital discharge, whichever occurs first | 
| Frequency of vomiting |  | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | 
| Frequency episodes of urination |  | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | 
| Frequency of liquid/watery stool |  | every 4 hours up to 24 hours or hospital discharge, whichever occurs first | 
| Time to resolution of liquid/water stool |  | up to 24 hours or hospital discharge, whichever comes first | 
| Stool for bacterial pathogen culture and viral antigens |  | up to 24 hours or hospital discharge, whichever comes first | 
| Time ready for discharge |  | At discharge or 48 hours whichever occurs first | 
| Medically confirmed adverse events collected throughout the study period |  | 0 hours through 7 days post discharge | 
| Record patient use of antibiotics during hospitalization |  | up to 24 hours or hospital discharge, whichever comes first |