PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
NCT ID: NCT03263871
Last Updated: 2019-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-10-14
2019-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
PTM202 and micro-nutrient sprinkles
PTM202
PTM202 given twice daily for 30 days.
micro-nutrient sprinkles
Micro-nutrient sprinkles will be given twice daily for 30 days.
Control
micro-nutrient sprinkles
micro-nutrient sprinkles
Micro-nutrient sprinkles will be given twice daily for 30 days.
Interventions
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PTM202
PTM202 given twice daily for 30 days.
micro-nutrient sprinkles
Micro-nutrient sprinkles will be given twice daily for 30 days.
Eligibility Criteria
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Inclusion Criteria
* -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 Criteria
* 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
6 Months
9 Months
ALL
Yes
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Virginia Commonwealth University
OTHER
University of Virginia
OTHER
Responsible Party
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Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, , Bangladesh
Countries
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Other Identifiers
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19993
Identifier Type: -
Identifier Source: org_study_id
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