Status:
COMPLETED
VS002A in the Treatment of Acute Watery Diarrhea in Infants and Young Children
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Entrinsic Bioscience Inc.
Conditions:
Acute Watery Diarrhoea
Eligibility:
MALE
6-36 years
Phase:
NA
Brief Summary
Background (brief): 1. Burden: Diarrhea is the second deadliest disease for under-five children globally and the situation is more serious in developing countries. It was responsible for 688 million ...
Detailed Description
Hypothesis to be tested: The amino acid-based ORS "VS002A" will reduce the duration of non-cholera, watery diarrhea in infants and young children when compared to treatment with standard WHO-ORS. Sp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06179589
Start Date
December 1 2020
End Date
April 30 2023
Last Update
December 22 2023
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh