Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
NCT ID: NCT02441426
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1796 participants
OBSERVATIONAL
2008-11-30
2017-04-30
Brief Summary
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The MAL-ED Project is designed to determine the impact of enteric infections/diarrhea that alter gut function and impair children's nutrition, growth and development to help develop new intervention strategies that can break the vicious enteric infection-malnutrition cycle and reduce its global burden.
The overall objective of the MAL-ED Project is to quantify the associations of specific enteric pathogens, measures of physical and mental development, micronutrient malnutrition, gut function biomarkers, the gut microbiome, and immune responses in very young children in resource-limited settings across eight sites that vary by culture, economics, geography, and climate.
The central hypothesis of the MAL-ED Project is that infection (and co-infection) with specific enteropathogens leads to impaired growth and development and to diminished immune response to orally administered vaccines by causing intestinal inflammation and/or by altering intestinal barrier and absorptive function. Data analyses will test for associations between enteropathogen infections and growth/development to help illuminate:
* which micro-organisms or mixed infections are most frequently associated with growth faltering and poor development; and
* at what age specific infections cause the most disruption to growth and development and impair immune response.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bangladesh
Birth cohort study community in Bangladesh is urban, and located in the Mirpur neighborhood of Dhaka.
Case control study is being conducted in the same catchment area. Cases defined as children 6-24 months of age with \<-2WAZ (weight for age) score, controls are age and community matched with \>-1WAZ.
No interventions assigned to this group
Brazil
Birth cohort study community in Brazil is urban, and located within the Papoco area of Fortaleza.
Case control study is being conducted in the same area as the cohort study. Cases are children 6 - 24 months of age, with \<-2 WAZ (weight for age) score, controls are age and community matched children with \>-1 WAZ.
No interventions assigned to this group
India
Birth cohort study community in India is urban, and located in the southern state of Tamil Nadu, specifically in Vellore.
No interventions assigned to this group
Nepal
Birth cohort study community in Nepal is semi-urban, and located in Bhaktapur, approximately 25km from Kathmandu.
No interventions assigned to this group
Pakistan
Birth cohort study community in Pakistan is rural, and located in Naushero Feroze, Sindh.
No interventions assigned to this group
Peru
Birth cohort study community in Peru is rural, and located approximately 15km from Iquitos in Loreto.
No interventions assigned to this group
South Africa
Birth cohort study community in South Africa is rural/peri-urban, and comprised of nine settlements within Limpopo Province.
No interventions assigned to this group
Tanzania
Birth cohort study community in Tanzania is rural, and located within Haydom.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Mother has another child inthe MAL-ED study.
* Pregnancy resulted in multiple birth (e.g., twins).
* Child has a severe disease requiring hospitalization for something other than for a typical healthy birth.
* Child has a severe or chronic condition diagnosed by a medical doctor (e.g., neonatal disease, renal disease, chronic heart failure, liver disease, cystic fibrosis, congenital conditions).
* Child has enteropathies diagnosed by medical doctor.
* Mother is living and unable to provide informed consent.
1 Minute
17 Days
ALL
Yes
Sponsors
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University of Virginia
OTHER
Johns Hopkins University
OTHER
Aga Khan University
OTHER
Christian Medical College, Vellore, India
OTHER
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Fogarty International Center of the National Institute of Health
NIH
Penn State University
OTHER
Foundation for the National Institutes of Health
OTHER
Responsible Party
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Principal Investigators
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Michael Gottlieb, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Fountation for the National Institutes of Health
Roger Glass, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fogarty International Center of the National Institute of Health
Locations
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International Centre for Diarrheal Disease Research, Bangladesh
Dhaka, , Bangladesh
Universidade Federal do CearĂ¡
Fortaleza, , Brazil
Christian Medical College
Vellore, , India
Institute of Medicine
Kathmandu, , Nepal
Aga Khan University
Karachi, , Pakistan
JHSPH Satellite Laboratory
Iquitos, , Peru
University of Venda
Limpopo, , South Africa
Haydom Lutheran Hospital
Haydom, , Tanzania
Countries
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References
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Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.
Arndt MB, Richardson BA, Mahfuz M, Ahmed T, Haque R, Gazi MA, John-Stewart GC, Denno DM, Scarlett JM, Walson JL; coordination with The Interactions of Malnutrition & Enteric Infections: Consequences for Child Health and Development Project Network. Plasma Fibroblast Growth Factor 21 Is Associated with Subsequent Growth in a Cohort of Underweight Children in Bangladesh. Curr Dev Nutr. 2019 Mar 30;3(5):nzz024. doi: 10.1093/cdn/nzz024. eCollection 2019 May.
Colston JM, Ahmed T, Mahopo C, Kang G, Kosek M, de Sousa Junior F, Shrestha PS, Svensen E, Turab A, Zaitchik B; MAL-ED Network. Evaluating meteorological data from weather stations, and from satellites and global models for a multi-site epidemiological study. Environ Res. 2018 Aug;165:91-109. doi: 10.1016/j.envres.2018.02.027. Epub 2018 Apr 21.
Colston JM, Penataro Yori P, Colantuoni E, Moulton LH, Ambikapathi R, Lee G, Rengifo Trigoso D, Siguas Salas M, Kosek MN. A methodologic framework for modeling and assessing biomarkers of environmental enteropathy as predictors of growth in infants: an example from a Peruvian birth cohort. Am J Clin Nutr. 2017 Jul;106(1):245-255. doi: 10.3945/ajcn.116.151886. Epub 2017 Jun 7.
Platts-Mills JA, Taniuchi M, Uddin MJ, Sobuz SU, Mahfuz M, Gaffar SA, Mondal D, Hossain MI, Islam MM, Ahmed AS, Petri WA, Haque R, Houpt ER, Ahmed T. Association between enteropathogens and malnutrition in children aged 6-23 mo in Bangladesh: a case-control study. Am J Clin Nutr. 2017 May;105(5):1132-1138. doi: 10.3945/ajcn.116.138800. Epub 2017 Apr 5.
Other Identifiers
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MAL-ED-47075
Identifier Type: -
Identifier Source: org_study_id
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