The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months

The Washington University

Status: Completed

Conditions: Enteropathy

Treatments: Dietary Supplement: Cow pea complementary food; Dietary Supplement: Common bean; Dietary Supplement: Corn soy flour

Study type: Interventional

Funder types: Other

Identifiers

NCT02472262

LG1

Details and patient eligibility

About

To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months to see if these improvements are correlated with specific changes in the enteric microbiome.

Enrollment: 355 patients

Sex: All

Ages: 5 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

children residing in catchment area of Limela, Machinga District and Ntenda (Chikwawa District), Malawi aged 6-11 months youngest eligible child in each household

Exclusion criteria

Unable to drink 20 mL of sugar water Demonstrating evidence of severe acute malnutrition Apparent need for acute medical treatment for an illness or injury Caregiver refusal to participate and return for 3 and 6 month follow-ups -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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355 participants in 3 patient groups

Cow pea complementary food

Experimental group

Description:

A legume-based complementary food made from cowpeas will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

Treatment:

Dietary Supplement: Cow pea complementary food

Common bean

Experimental group

Description:

A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

Treatment:

Dietary Supplement: Common bean

Corn Soy Flour

Active Comparator group

Description:

Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.

Treatment:

Dietary Supplement: Corn soy flour