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
• Interventions: Dietary Supplement: cowpeas complementary food; Dietary Supplement: common bean complementary food; Dietary Supplement: corn-soy flour

• 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

Study Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Study Start: 2015-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cowpeas	cowpeas complementary food	Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Common bean	common bean complementary food	Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Corn Soy Flour	corn-soy flour	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.

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