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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials

Authors: Indi Trehan, Nicole S. Benzoni, Alfred Z. Wang, Lucy B. Bollinger, Theresa N. Ngoma, Ulemu K. Chimimba, Kevin B. Stephenson, Sophia E. Agapova, Kenneth M. Maleta, Mark J. Manary

Published in: Trials | Issue 1/2015

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Abstract

Background

Interventions to decrease the burden of childhood malnutrition are urgently needed, as millions of children die annually owing to undernutrition and hundreds of millions more are left cognitively and physically stunted. Environmental enteric dysfunction (EED), a pervasive chronic subclinical inflammatory condition among children that develops when complementary foods are introduced, places them at high risk of stunting, malabsorption, and poor oral vaccine efficacy. Improved interventions to reduce the burden of EED and stunting are expected to markedly improve the nutritional status and survival of children throughout resource-limited settings.

Methods/Design

We will conduct, in parallel, two prospective randomized controlled clinical trials to determine whether common beans or cowpeas improve growth, ameliorate EED, and alter the intestinal microbiome during a high-risk period in the lives of rural Malawian children. Study 1 will enroll children at 6 months of age and randomize them to receive common beans, cowpeas, or a standard complementary food for 6 months. Anthropometry will be compared among the three groups; EED will be assessed using a dual-sugar absorption test and by quantifying human intestinal mRNA for inflammatory messages; and the intestinal microbiota will be characterized by deep sequencing of fecal DNA, to enumerate host microbial populations and their metabolic capacity. Study 2 will enroll children 12–23 months old and follow them for 12 months, with similar interventions and assessments as Study 1.

Discussion

By amalgamating the power of rigorous clinical trials and advanced biological analysis, we aim to elucidate the potential of two grain legumes to reduce stunting and EED in a high-risk population. Legumes have potential as an affordable and effective complementary food intervention, given their cultural acceptability, nutritional content, and agricultural feasibility in sub-Saharan Africa.

Trial registration

Clinicaltrials.gov NCT02472262 and NCT02472301.
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Metadata
Title
Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials
Authors
Indi Trehan
Nicole S. Benzoni
Alfred Z. Wang
Lucy B. Bollinger
Theresa N. Ngoma
Ulemu K. Chimimba
Kevin B. Stephenson
Sophia E. Agapova
Kenneth M. Maleta
Mark J. Manary
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1027-0

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