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Clinical trialNCT02441426UnknownObservational

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

SponsorFoundation for the National Institutes of HealthEnrollment1,796Cognitive DevelopmentDiarrheaImmune ResponseMalnutritionStuntingWasting
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Michael Gottlieb, Ph.D.

    Fountation for the National Institutes of Health

    Principal Investigator
  • Roger Glass, M.D.

    Fogarty International Center of the National Institute of Health

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Bangladesh
  • International Centre for Diarrheal Disease Research, Bangladesh

    Dhaka, Bangladesh

Brazil
  • Universidade Federal Do Ceará

    Fortaleza, Brazil

India
  • Christian Medical College

    Vellore, India

Nepal
  • Institute of Medicine

    Kathmandu, Nepal

Pakistan
  • Aga Khan University

    Karachi, Pakistan

Peru
  • Jhsph Satellite Laboratory

    Iquitos, Peru

South Africa
  • University of Venda

    Limpopo, South Africa

Tanzania
  • Haydom Lutheran Hospital

    Haydom, Tanzania

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2008
Primary completion
28 Feb 2017
Completion
30 Apr 2017
Last update posted
12 May 2015
Registered enrollment
1,796
Registry id
NCT02441426

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.