Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
- Conditions
- StuntingMalnutritionWastingImmune ResponseDiarrheaCognitive Development
- Registration Number
- NCT02441426
- Lead Sponsor
- Foundation for the National Institutes of Health
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1796
- Less than 17 days old.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diarrhea Each diarrheal episode willbe recorded for up to 24 months of age. All diarrheal samples are analyzed for the presence of bacterial, viral, and parasitic pathogens. Normal stool is collected monthly and analyzed for the same list of 57 different pathogens.
Anthropometry Anthropomentry will be recorded each month for up to 24 months of age. Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth.
Cognitive development Cognitive development will be recorded 24 months of age. A battery of tests include the Bayley Scales of Infant Development, MacArthur Words and Gestures, Infant Temperament Scale, HOME inventory, SRQ-20 and Raven's Combined Progressive Matrices.
Vaccine response Vaccine response will be recorded at 24 months of age. Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
- Secondary Outcome Measures
Name Time Method Gut integrity Gut integritywill be recorded at at 15 months of age. Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Gut inflammation Gut inflammation will be recorded each month for up to 24 months of age. Stool biomarkers will be evaluated to detect gut and systemic inflammation.
Trial Locations
- Locations (8)
Universidade Federal do Ceará
🇧🇷Fortaleza, Brazil
Christian Medical College
🇮🇳Vellore, India
Institute of Medicine
🇳🇵Kathmandu, Nepal
Aga Khan University
🇵🇰Karachi, Pakistan
International Centre for Diarrheal Disease Research, Bangladesh
🇧🇩Dhaka, Bangladesh
JHSPH Satellite Laboratory
🇵🇪Iquitos, Peru
University of Venda
🇿🇦Limpopo, South Africa
Haydom Lutheran Hospital
🇹🇿Haydom, Tanzania