Efficacy and Safety of VS002A With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children

Study Overview
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Brief Summary
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Randomized double blinded clinical trial comparing amino acid based oral rehydration solution/medical food and glucose-based oral rehydration solution is infectious diarrhea in pediatric population

Official Title
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Clinical Trial to Compare the Efficacy and Safety of a Multiple Amino-acid Based ORS VS002A With the Standard WHO-ORS in the Management of Non-cholera Acute Watery Diarrhea in Infants and Young Children

Conditions
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Diarrhea, Infantile

Intervention / Treatment
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* Other: VS002A
* Other: WHO-ORS


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age: 6 months - 36 months, Duration of diarrhea ≤48 hours, Some dehydration (judged clinically according to the Dhaka method), Written informed consent by either parent/guardian. Exclusion criteria: Severe malnutrition (Weight-for-length WLZ/WHZ/WAZ <-3 or presence of nutritional edema) Patients with diarrhea due to cholera. Systemic illness (e.g. Pneumonia, tuberculosis, enteric fever, meningitis etc.) Bloody diarrhea Any congenital anomaly or disorder (e.g. diagnosed inborn error of metabolism, congenital cardiac disease, seizure disorders, hypothyroidism, Down's syndrome etc.) Requirement of additional intravenous fluids after being provided with an IV for 4 hours on admission if severely dehydrated Has documentation of taking antibiotic and/or antidiarrheal within the last 48 hours prior to hospitalization.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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Male

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
Interventional Model Description: Randomized double blinded
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VS002A<br>Amino acid based ORS/medical food (VS002A). Initial treatment dosing with VS002A will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. | Other: VS002A<br>* Amino acid based ORS/Medical food<br>|
| Active Comparator: Standard WHO-ORS<br>Standard WHO-ORS. Initial treatment dosing with WHO-ORS will be estimated using body weight in accordance with 5-10 ml/kg after each loose stool as per icddr,b guidelines, to maintain ongoing loss. | Other: WHO-ORS<br>* WHO Oral rehydration solution, which is glucose based<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea in hospital (hours) | number of hours of diarrhea after randomization | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool output | Stool output in the 1st 24 hours of hospitalization (g/kg body wt.), divided into two 12-hour periods | 1 day | 
| Total stool output | Total amount of stool output during the study | 5 days | 
| ORS intake in the 1st 24 hours of hospitalization | Amount of intervention drink consumed in the first 24 hours after randomization | 1 day | 
| Total ORS intake | Amount of intervention drink consumed throughout the duration of the study | 5 days | 
| Unscheduled IV (frequency/ORS group) | Frequency of IV fluids between he 2 groups | 5 days | 
| Treatment failure (frequency/ORS group) | Frequency of treatment failures between the two groups | 5 days | 
| Output and frequency of vomiting | Amount and frequency of vomiting between the two groups | 5 days | 
| Change in body weight (between pre-randomization and post-treatment) | Body weight at randomization and post treatment | 5 days | 
| Urine output in the 1st 24 hours of hospitalization (g/kg body wt.) | Amount of urine in the first 24 hours after randomization | 1 day | 
| Total urine output during hospitalization | Total urine output (g/kg body wt.) | 5 days | 
| Documented infectious agent | Stool culture and recording of infectious agent causing the diarrhea | 5 days |