Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development

NCT ID: NCT02441426

Last Updated: 2015-05-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

1796 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2017-04-30

Brief Summary

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Malnutrition is considered one of the most prevalent risk factors for morbidity and mortality in children under five. An estimated 20% of children in the developing world are malnourished \[1\] and poor nutrition is linked to more than half of all child deaths worldwide \[2\]. Malnutrition in early childhood may lead to cognitive and physical deficits and may cause similar deficits in future generations as malnourished mothers give birth to low birth weight children \[3\]. In addition, malnutrition increases susceptibility and incidence of infections and is associated with diminished response to vaccines.

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.

Detailed Description

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Conditions

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Diarrhea Malnutrition Stunting Wasting Immune Response Cognitive Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Less than 17 days old.

Exclusion Criteria

* Mother is less than 16 years of age.
* 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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

17 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role collaborator

Christian Medical College, Vellore, India

OTHER

Sponsor Role collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Foundation for the National Institutes of Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Universidade Federal do CearĂ¡

Fortaleza, , Brazil

Site Status

Christian Medical College

Vellore, , India

Site Status

Institute of Medicine

Kathmandu, , Nepal

Site Status

Aga Khan University

Karachi, , Pakistan

Site Status

JHSPH Satellite Laboratory

Iquitos, , Peru

Site Status

University of Venda

Limpopo, , South Africa

Site Status

Haydom Lutheran Hospital

Haydom, , Tanzania

Site Status

Countries

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Bangladesh Brazil India Nepal Pakistan Peru South Africa Tanzania

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.

Reference Type DERIVED
PMID: 40840991 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31093598 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29684739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28592604 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28381477 (View on PubMed)

Other Identifiers

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MAL-ED-47075

Identifier Type: -

Identifier Source: org_study_id

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