The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds

Conditions
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Environmental Enteropathy

Intervention / Treatment
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* Dietary Supplement: cowpeas complementary food
* Dietary Supplement: corn-soy flour
* Dietary Supplement: common bean complementary food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cowpeas<br>Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary Supplement: cowpeas complementary food<br>* cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.<br>|
| Experimental: Common bean<br>Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary Supplement: common bean complementary food<br>* common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.<br>|
| Active Comparator: Corn Soy Flour<br>Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months. | Dietary Supplement: corn-soy flour<br>* Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 3 months | 
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 6 months | 
| Dual Sugar Absorption Test | lactulose-mannitol ratio in urine | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 3 months | 
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 6 months | 
| Lactulose Excretion | percentage of ingested lactulose excreted in urine | 12 months | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 3 months | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 6 months | 
| Mannitol Excretion | percentage of ingested mannitol excreted in urine | 12 months |