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

Washington University School of Medicine337 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

337

Conditions

Environmental Enteropathy

Interventions

cowpeas complementary foodDIETARY_SUPPLEMENT

cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

corn-soy flourDIETARY_SUPPLEMENT

Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

common bean complementary foodDIETARY_SUPPLEMENT

common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Blantyre, Malawi

Outcomes

Primary Outcomes

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 3 months

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 6 months

Dual Sugar Absorption Test

lactulose-mannitol ratio in urine

Time frame: 12 months

Secondary Outcomes

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 3 months

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 6 months

Lactulose Excretion

percentage of ingested lactulose excreted in urine

Time frame: 12 months

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 3 months

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 6 months

Mannitol Excretion

percentage of ingested mannitol excreted in urine

Time frame: 12 months

Data from ClinicalTrials.gov

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