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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Single-blinded, Prospective Clinical Trials Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 6-11 Months

Conditions
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Enteropathy

Intervention / Treatment
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* Dietary Supplement: Cow pea complementary food
* Dietary Supplement: Corn soy flour
* Dietary Supplement: Common bean


Participation Criteria
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Eligibility Criteria
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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 - -

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 12 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cow pea complementary food<br>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. | Dietary Supplement: Cow pea complementary food<br>* 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.<br>|
| Experimental: Common bean<br>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. | Dietary Supplement: Common bean<br>* 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.<br>|
| Active Comparator: Corn Soy Flour<br>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. | Dietary Supplement: Corn soy flour<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups |  | 6 months | 
| Mid-upper Arm Circumference at 9 and 12 Months of Age | Mid-upper arm circumference in cm | 6 months | 
| Weight-for-height z Score at 9 and 12 Months of Age | weight for height z-score at 9 and 12 months of age | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Environmental, Enteric