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

Primary Purpose

Enteropathy

Status

Completed

Phase

Not Applicable

Locations

Malawi

Study Type

Interventional

Intervention

Cow pea complementary food

Corn soy flour

Common bean

About this trial

This is an interventional treatment trial for Enteropathy focused on measuring Environmental, Enteric

Eligibility Criteria

5 Months - 12 Months (Child)All SexesAccepts 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 -

Sites / Locations

University of Malawi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Cow pea complementary food

Common bean

Corn Soy Flour

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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

% 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

Secondary Outcome Measures

16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups

Mid-upper Arm Circumference at 9 and 12 Months of Age

Mid-upper arm circumference in cm

Weight-for-height z Score at 9 and 12 Months of Age

weight for height z-score at 9 and 12 months of age

Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population

Full Information

NCT ID

NCT02472262

First Posted

June 8, 2015

Last Updated

November 18, 2019

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02472262

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enteropathy

Keywords

Environmental, Enteric

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

355 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cow pea complementary food

Arm Type

Experimental

Arm 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.

Arm Title

Common bean

Arm Type

Experimental

Arm 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.

Arm Title

Corn Soy Flour

Arm Type

Active Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Cow pea complementary food

Intervention 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Corn soy flour

Intervention 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Common bean

Intervention 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.

Primary Outcome Measure Information:

Title

Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.

Description

Change in length-for-age z score from enrollment to end of study 6 months

Time Frame

6 months

Title

% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age

Description

percent of lactulose found in urine during the dual sugar absorption test

Time Frame

6 month

Secondary Outcome Measure Information:

Title

16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups

Time Frame

6 months

Title

Mid-upper Arm Circumference at 9 and 12 Months of Age

Description

Mid-upper arm circumference in cm

Time Frame

6 months

Title

Weight-for-height z Score at 9 and 12 Months of Age

Description

weight for height z-score at 9 and 12 months of age

Time Frame

6 months

Title

Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Months

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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 - -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Manary, MD

Organizational Affiliation

Washington University School of Medince

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Malawi

City

Blantyre

Country

Malawi

12. IPD Sharing Statement

Citations:

PubMed Identifier

32047925

Citation

Ordiz MI, Janssen S, Humphrey G, Ackermann G, Stephenson K, Agapova S, Divala O, Kaimila Y, Maleta K, Zhong C, Knight R, Trehan I, Tarr PI, Rusconi B, Manary MJ. The effect of legume supplementation on the gut microbiota in rural Malawian infants aged 6 to 12 months. Am J Clin Nutr. 2020 Apr 1;111(4):884-892. doi: 10.1093/ajcn/nqaa011.

Results Reference

derived

PubMed Identifier

31620672

Citation

Ordiz MI, Semba RD, Moaddel R, Rolle-Kampczyk U, von Bergen M, Herberth G, Khadeer M, Roder S, Manary MJ. Serum Amino Acid Concentrations in Infants from Malawi are Associated with Linear Growth. Curr Dev Nutr. 2019 Aug 29;3(10):nzz100. doi: 10.1093/cdn/nzz100. eCollection 2019 Oct.

Results Reference

derived

PubMed Identifier

31022095

Citation

Kaimila Y, Pitman RT, Divala O, Hendrixson DT, Stephenson KB, Agapova S, Trehan I, Maleta K, Manary MJ. Development of Acute Malnutrition Despite Nutritional Supplementation in Malawi. J Pediatr Gastroenterol Nutr. 2019 May;68(5):734-737. doi: 10.1097/MPG.0000000000002241.

Results Reference

derived

PubMed Identifier

29955682

Citation

Borresen EC, Zhang L, Trehan I, Nealon NJ, Maleta KM, Manary MJ, Ryan EP. The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. Curr Dev Nutr. 2017 Sep 21;1(10):e001610. doi: 10.3945/cdn.117.001610. eCollection 2017 Oct.

Results Reference

derived

PubMed Identifier

29092882

Citation

Stephenson KB, Agapova SE, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial. Am J Clin Nutr. 2017 Dec;106(6):1500-1507. doi: 10.3945/ajcn.117.160986. Epub 2017 Nov 1.

Results Reference

derived

PubMed Identifier

26578308

Citation

Trehan I, Benzoni NS, Wang AZ, Bollinger LB, Ngoma TN, Chimimba UK, Stephenson KB, Agapova SE, Maleta KM, Manary MJ. Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials. Trials. 2015 Nov 14;16:520. doi: 10.1186/s13063-015-1027-0.

Results Reference

derived

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

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