NCT03263871CompletedNot Applicable
Pilot Study of PTM202 for the Treatment of Environmental Enteric Dysfunction (EED)
University of Virginia1 site in 1 country200 target enrollmentStarted: October 14, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Virginia
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- EED biomarker composite score
Study Overview
Brief Summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to 9 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention
Experimental
PTM202 and micro-nutrient sprinkles
Intervention: PTM202 (Dietary Supplement)
Intervention
Experimental
PTM202 and micro-nutrient sprinkles
Intervention: micro-nutrient sprinkles (Dietary Supplement)
Control
Other
micro-nutrient sprinkles
Intervention: micro-nutrient sprinkles (Dietary Supplement)
Outcomes
Primary Outcomes
EED biomarker composite score
Time Frame: 4 months
composite score of fecal Reg 1B, fecal myeloperoxidase, urinary lactulose: mannitol ratio, serum soluable-CD14, and serum C-reactive protein
Secondary Outcomes
- Glucose hydrogen breath test(4 months)
- Weight gain(4 months)
- Height gain(4 months)
- Number of diarrheal episodes(4 months)
Investigators
Study Sites (1)
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