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

Not Applicable

Completed

• Conditions: Enteropathy
• Interventions: Dietary Supplement: Corn soy flour; Dietary Supplement: Cow pea complementary food; Dietary Supplement: Common bean

• Registration Number: NCT02472262
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-15
• Study Start: 2015-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2019-10-22
• Results First Submitted QC: 2019-10-22
• Status Verified: 2019-11
• Results First Posted: 2019-11-13
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corn Soy Flour	Corn soy flour	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.
Cow pea complementary food	Cow pea complementary food	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.
Common bean	Common bean	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.

Primary Outcome Measures

Name	Time	Method
Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.	6 months	Change in length-for-age z score from enrollment to end of study 6 months
% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age	6 month	percent of lactulose found in urine during the dual sugar absorption test

Secondary Outcome Measures

Name	Time	Method
Weight-for-height z Score at 9 and 12 Months of Age	6 months	weight for height z-score at 9 and 12 months of age
16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups	6 months
Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population	6 months
Mid-upper Arm Circumference at 9 and 12 Months of Age	6 months	Mid-upper arm circumference in cm

Trial Locations

Locations (1)

University of Malawi; 🇲🇼 Blantyre, Malawi