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

NCT02441426 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1796

Last updated 2015-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Diarrhea
  • Malnutrition
  • Stunting
  • Wasting
  • Immune Response
  • Cognitive Development

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Aga Khan University

    collaborator OTHER
  • Christian Medical College, Vellore, India

    collaborator OTHER
  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    collaborator OTHER
  • Fogarty International Center of the National Institute of Health

    collaborator NIH
  • Penn State University

    collaborator OTHER
  • Foundation for the National Institutes of Health

    lead OTHER

Principal Investigators

  • Michael Gottlieb, Ph.D. · Fountation for the National Institutes of Health

  • Roger Glass, M.D. · Fogarty International Center of the National Institute of Health

Eligibility

Min Age
1 Minute
Max Age
17 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2017-02-28
Completion
2017-04-30

Countries

  • Bangladesh
  • Brazil
  • India
  • Nepal
  • Pakistan
  • Peru
  • South Africa
  • Tanzania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441426 on ClinicalTrials.gov