The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
Not Applicable
Completed
- Conditions
- Environmental Enteropathy
- Registration Number
- NCT02472301
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
Inclusion Criteria
- children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
- aged 12-35 months
- youngest eligible child in each household
Exclusion Criteria
Unable to drink 20 mL of sugar water
- Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- Apparent need for acute medical treatment for an illness or injury
- Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Dual Sugar Absorption Test 12 months lactulose-mannitol ratio in urine
- Secondary Outcome Measures
Name Time Method Mannitol Excretion 12 months percentage of ingested mannitol excreted in urine
Lactulose Excretion 12 months percentage of ingested lactulose excreted in urine