PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
Not Applicable
Completed
- Conditions
- Environmental Enteric Dysfunction
- Interventions
- Dietary Supplement: PTM202Dietary Supplement: micro-nutrient sprinkles
- Registration Number
- NCT03263871
- Lead Sponsor
- University of Virginia
- Brief Summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention PTM202 PTM202 and micro-nutrient sprinkles Intervention micro-nutrient sprinkles PTM202 and micro-nutrient sprinkles Control micro-nutrient sprinkles micro-nutrient sprinkles
- Primary Outcome Measures
Name Time Method EED biomarker composite score 4 months composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
- Secondary Outcome Measures
Name Time Method Glucose hydrogen breath test 4 months Weight gain 4 months Height gain 4 months Number of diarrheal episodes 4 months
Trial Locations
- Locations (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
🇧🇩Dhaka, Bangladesh