Status:
COMPLETED
PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University
Conditions:
Environmental Enteric Dysfunction
Eligibility:
All Genders
6-9 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Eligibility Criteria
Inclusion
- Aged 6 - 9 months old
- -1\> Weight-for-age Z score \> -3
- Parental consent to participate and receive daily supplementation with either PTM202 and/or micro-nutrient sprinkles, participate in specimen collection
Exclusion
- Presence of known kidney, liver, heart, developmental, or neurologic disease
- Allergy to milk and/or egg (assessed by history)
- Milk intolerance (assessed by history)
- Abnormal liver or kidney function tests
- Family is planning to move from the study area or children is enrolled to the other clinical trial within 3 months of follow up
- Child being exclusively breast fed at the time of enrollment
Key Trial Info
Start Date :
October 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03263871
Start Date
October 14 2017
End Date
February 15 2019
Last Update
April 22 2019
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh