Environmental Enteric Dysfunction
Conditions
Keywords
nutrition
Brief summary
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
Interventions
DIETARY_SUPPLEMENTPTM202
PTM202 given twice daily for 30 days.
DIETARY_SUPPLEMENTmicro-nutrient sprinkles
Micro-nutrient sprinkles will be given twice daily for 30 days.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Virginia Commonwealth University
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 9 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Weight gain | 4 months |
| Height gain | 4 months |
| Number of diarrheal episodes | 4 months |
| Glucose hydrogen breath test | 4 months |
Countries
Bangladesh
Outcome results
None listed