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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

Author
item TREHAN, INDI - Washington University
item BENZONI, NICOLE - Washington University
item WANG, ALFRED - University Of Texas Southwestern Medical Center
item BOLLINGER, LUCY - Washington University
item NGOMA, THERESA - Lilongwe University Of Agriculture And Natural Resources
item CHIMIMBA, ULEMU - Lilongwe University Of Agriculture And Natural Resources
item STEPHENSON, KEVIN - Washington University
item AQAPOVA, SOPHIA - Columbia University - New York
item MALETA, KENNETH - University Of Malawi
item MANARY, MARK - Children'S Nutrition Research Center (CNRC)

Submitted to: Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 10/21/2015
Publication Date: 11/14/2015
Citation: Trehan, I., Benzoni, N.S., Wang, A.Z., Bollinger, L.B., Ngoma, T.N., Chimimba, U.K., Stephenson, K.B., Aqapova, S.E., Maleta, K.M., Manary, M.J. 2015. 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. 16:520.

Interpretive Summary: Improved interventions are needed to reduce irritation of the gut that places children at risk of stunting. A trial is being conducted to determine if common beans or cowpeas would improve gut health and linear growth. Common beans and cowpeas would be a feasible was to treat gut inflammation and stunting because they are culturally acceptable and easily grown in sub-Saharan Africa.

Technical Abstract: 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. 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. 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.