Status:
COMPLETED
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Environmental Enteric Dysfunction
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on e...
Detailed Description
Primary Objectives 1. To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age 2. To assess the efficacy of Enterade (VS001) in treatment of environm...
Eligibility Criteria
Inclusion
- Length-for-age Z score (LAZ) between -1 and -3 standard deviations
- Lactulose mannitol ratio \>0.09
Exclusion
- Presence of known congenital or chronic diseases other than malnutrition
- Diarrhea (\> 3 unformed stools in a 24-hour window) in the 7 days prior to screening
- Anticipated unavailability for study visits
- A sibling previously enrolled in this study
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05291559
Start Date
July 18 2022
End Date
September 7 2022
Last Update
September 10 2022
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh