Overview

This trial is active, not recruiting.

Conditions diarrhea, malnutrition, stunting, wasting, immune response, cognitive development
Sponsor Foundation for the National Institutes of Health
Collaborator University of Virginia
Start date November 2008
End date February 2017
Trial size 1796 participants
Trial identifier NCT02441426, MAL-ED-47075

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.
Birth cohort study community in India is urban, and located in the southern state of Tamil Nadu, specifically in Vellore.
Birth cohort study community in Nepal is semi-urban, and located in Bhaktapur, approximately 25km from Kathmandu.
Birth cohort study community in Pakistan is rural, and located in Naushero Feroze, Sindh.
Birth cohort study community in Peru is rural, and located approximately 15km from Iquitos in Loreto.
Birth cohort study community in South Africa is rural/peri-urban, and comprised of nine settlements within Limpopo Province.
Birth cohort study community in Tanzania is rural, and located within Haydom.

Primary Outcomes

Measure
Diarrhea
time frame: Each diarrheal episode willbe recorded for up to 24 months of age.
Anthropometry
time frame: Anthropomentry will be recorded each month for up to 24 months of age.
Cognitive development
time frame: Cognitive development will be recorded at 6 months of age.
Vaccine response
time frame: Vaccine response will be recorded at 7 months of age.
Cognitive development
time frame: Cognitive development will be recorded at 8 months of age.
Cognitive development
time frame: Cognitive development will be recorded at 15 months of age.
Vaccine response
time frame: Vaccine response will be recorded at 15 months of age.
Cognitive development
time frame: Cognitive development will be recorded 24 months of age.
Vaccine response
time frame: Vaccine response will be recorded at 24 months of age.

Secondary Outcomes

Measure
Gut inflammation
time frame: Gut inflammation will be recorded each month for up to 24 months of age.
Gut integrity
time frame: Gut integritywill be recorded at at 3 months of age.
Gut integrity
time frame: Gut integritywill be recorded at at 6 months of age.
Gut integrity
time frame: Gut integritywill be recorded at at 9 months of age.
Gut integrity
time frame: Gut integritywill be recorded at at 15 months of age.

Eligibility Criteria

Male or female participants up to 17 days old.

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.

Additional Information

Official title Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
Principal investigator Michael Gottlieb, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Foundation for the National Institutes of Health.