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

Malnutrition Clinical Trial

— MAL-ED  

Official title:

Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02441426
• Other study ID #: MAL-ED-47075
• Status: Active, not recruiting
• Phase: N/A
• First received: May 4, 2015
• Last updated: May 7, 2015
• Start date: November 2008
• Est. completion date: April 2017

Study information

• Verified date: May 2015
• Source: Foundation for the National Institutes of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Health Ministry, Council of National Health, National Ethical Research CommitteeIndia: Indian Council of Medical Research, Health Ministry Screening CommitteeNepal: Nepal Health Research Council, Ethical Review BoardPeru: Health Ministry, LoretoSouth Africa: Limpopo Provincial Government, Dept. of Health and Social DevelopmentTanzania: National Institute for Medical Research, Medical Research Coordinating CommitteeUnited States: Federal Policy for the Protection of Human Subjects 45 CFR Part 46 - Department of Health and Human Services
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1796
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrheal Disease Research, Bangladesh	Dhaka
Brazil	Universidade Federal do Ceará	Fortaleza
India	Christian Medical College	Vellore
Nepal	Institute of Medicine	Kathmandu
Pakistan	Aga Khan University	Karachi
Peru	JHSPH Satellite Laboratory	Iquitos
South Africa	University of Venda	Limpopo
Tanzania	Haydom Lutheran Hospital	Haydom

Sponsors (8)

Lead Sponsor	Collaborator
Foundation for the National Institutes of Health	Aga Khan University, Christian Medical College, Vellore, India, Henry M. Jackson Foundation for the Advancement of Military Medicine, Johns Hopkins University, National Institutes of Health, Fogarty International Center, Penn State University, University of Virginia

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diarrhea	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.	Each diarrheal episode willbe recorded for up to 24 months of age.	No
Primary	Anthropometry	Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth.	Anthropomentry will be recorded each month for up to 24 months of age.	No
Primary	Cognitive development	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.	Cognitive development will be recorded at 6 months of age.	No
Primary	Vaccine response	Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.	Vaccine response will be recorded at 7 months of age.	No
Primary	Cognitive development	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.	Cognitive development will be recorded at 8 months of age.	No
Primary	Cognitive development	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.	Cognitive development will be recorded at 15 months of age.	No
Primary	Vaccine response	Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.	Vaccine response will be recorded at 15 months of age.	No
Primary	Cognitive development	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.	Cognitive development will be recorded 24 months of age.	No
Primary	Vaccine response	Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.	Vaccine response will be recorded at 24 months of age.	No
Secondary	Gut inflammation	Stool biomarkers will be evaluated to detect gut and systemic inflammation.	Gut inflammation will be recorded each month for up to 24 months of age.	No
Secondary	Gut integrity	Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.	Gut integritywill be recorded at at 3 months of age.	No
Secondary	Gut integrity	Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.	Gut integritywill be recorded at at 6 months of age.	No
Secondary	Gut integrity	Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.	Gut integritywill be recorded at at 9 months of age.	No
Secondary	Gut integrity	Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.	Gut integritywill be recorded at at 15 months of age.	No

External Links

•   "The Malnutrition and Enteric Disease Study (MAL-ED): Understanding the Consequences for Child Health and Development: CID supplement V59 suppl4; 2014
•   MAL-ED Project website