Status:
COMPLETED
Efficacy and Safety of "VS002A" With the Standard WHO-ORS in Non-cholera Acute Watery Diarrhea in Infants and Young Children
Lead Sponsor:
Entrinsic Bioscience Inc.
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Diarrhea, Infantile
Eligibility:
MALE
6-36 years
Phase:
NA
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2022
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT04677296
Start Date
June 16 2021
End Date
September 5 2022
Last Update
March 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ICDDR,B
Dhaka, Bangladesh