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

November 18, 2019 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Blantyre, Malawi
        • University of Malawi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 -

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: 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.
Experimental: 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.
Dietary supplement: 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.
Active Comparator: 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.
Dietary supplement: 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.

What is the study measuring?

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.
Time Frame: 6 months
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
Time Frame: 6 month
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
Time Frame: 6 months
6 months
Mid-upper Arm Circumference at 9 and 12 Months of Age
Time Frame: 6 months
Mid-upper arm circumference in cm
6 months
Weight-for-height z Score at 9 and 12 Months of Age
Time Frame: 6 months
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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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