Environmental Enteric Dysfunction Clinical Trial
Official title:
Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Verified date | April 2019 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Status | Completed |
Enrollment | 200 |
Est. completion date | February 15, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 9 Months |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | International Centre for Diarrhoeal Disease Research, Bangladesh, Virginia Commonwealth University |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EED biomarker composite score | composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein | 4 months | |
Secondary | Weight gain | 4 months | ||
Secondary | Height gain | 4 months | ||
Secondary | Number of diarrheal episodes | 4 months | ||
Secondary | Glucose hydrogen breath test | 4 months |
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