DiarrheaMAL-EDNCT02441426
Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
An observational study of Diarrhea and Malnutrition, run by Foundation for the National Institutes of Health at 8 sites in 8 countries.
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]. Read more about this study
- Who is it for?
- Ages 1 minute to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Malnutrition, Stunting
- How many people
- 1,796 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Nov 2008to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population for the MAL-ED Project is a birth cohort. Pregnant women were identified from their communities, consented and the child will be enrolled.
Who may be able to join
- Less than 17 days old.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Bangladesh1 site
International Centre for Diarrheal Disease Research, Bangladesh
Dhaka
About this study
Official title: Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
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.
Read more
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
- Keywords
- Cognitive development, Diarrheal disease, Enteric infections, Malnutrition, Vaccine Response, Enteropathy, Antibiotic use, Micronutrients, Breast feeding, Gut inflammation
- Medical subject headings
- Diarrhea, Malnutrition, Growth Disorders, Cachexia, Intestinal Diseases, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bangladesh | 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. | |
| Brazil | 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. | |
| India | Birth cohort study community in India is urban, and located in the southern state of Tamil Nadu, specifically in Vellore. | |
| Nepal | Birth cohort study community in Nepal is semi-urban, and located in Bhaktapur, approximately 25km from Kathmandu. | |
| Pakistan | Birth cohort study community in Pakistan is rural, and located in Naushero Feroze, Sindh. | |
| Peru | Birth cohort study community in Peru is rural, and located approximately 15km from Iquitos in Loreto. | |
| South Africa | Birth cohort study community in South Africa is rural/peri-urban, and comprised of nine settlements within Limpopo Province. | |
| Tanzania | Birth cohort study community in Tanzania is rural, and located within Haydom. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each diarrheal episode willbe recorded for up to 24 months of age.
Anthropometry
Head Circumference, length, and weight are measured monthly on the anniversary of the child's birth.
Measured: Anthropomentry will be recorded each month for up to 24 months of age.
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.
Measured: Cognitive development will be recorded at 6 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Measured: Vaccine response will be recorded at 7 months of age.
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.
Measured: Cognitive development will be recorded at 8 months of age.
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.
Measured: Cognitive development will be recorded at 15 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Measured: Vaccine response will be recorded at 15 months of age.
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.
Measured: Cognitive development will be recorded 24 months of age.
Vaccine response
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Measured: Vaccine response will be recorded at 24 months of age.
Secondary outcomes (5)
Gut inflammation
Stool biomarkers will be evaluated to detect gut and systemic inflammation.
Measured: Gut inflammation will be recorded each month for up to 24 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Measured: Gut integritywill be recorded at at 3 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Measured: Gut integritywill be recorded at at 6 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Measured: Gut integritywill be recorded at at 9 months of age.
Gut integrity
Intestinal absorptive capacity and barrier function will be assessed by dual sugar permeability test.
Measured: Gut integritywill be recorded at at 15 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2008
- Primary completionFeb 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,796 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for the National Institutes of Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, Johns Hopkins University, Aga Khan University, Christian Medical College, Vellore, India, Henry M. Jackson Foundation for the Advancement of Military Medicine, Fogarty International Center of the National Institute of Health, Penn State University
- Responsible party
- Sponsor
- Investigators
- Michael Gottlieb, Ph.D., Principal investigator, Fountation for the National Institutes of HealthRoger Glass, M.D., Principal investigator, Fogarty International Center of the National Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441426
- Sponsor's protocol ID
- MAL-ED-47075
- Acronym
- MAL-ED
- Status last verified
- May 2015
- First submitted
- 4 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.
PubMed 40840991Arndt MB, Richardson BA, Mahfuz M, Ahmed T, Haque R, Gazi MA, John-Stewart GC, Denno DM, Scarlett JM, Walson JL; coordination with The Interactions of Malnutrition & Enteric Infections: Consequences for Child Health and Development Project Network. Plasma Fibroblast Growth Factor 21 Is Associated with Subsequent Growth in a Cohort of Underweight Children in Bangladesh. Curr Dev Nutr. 2019 Mar 30;3(5):nzz024. doi: 10.1093/cdn/nzz024. eCollection 2019 May.
PubMed 31093598Colston JM, Ahmed T, Mahopo C, Kang G, Kosek M, de Sousa Junior F, Shrestha PS, Svensen E, Turab A, Zaitchik B; MAL-ED Network. Evaluating meteorological data from weather stations, and from satellites and global models for a multi-site epidemiological study. Environ Res. 2018 Aug;165:91-109. doi: 10.1016/j.envres.2018.02.027. Epub 2018 Apr 21.
PubMed 29684739Colston JM, Penataro Yori P, Colantuoni E, Moulton LH, Ambikapathi R, Lee G, Rengifo Trigoso D, Siguas Salas M, Kosek MN. A methodologic framework for modeling and assessing biomarkers of environmental enteropathy as predictors of growth in infants: an example from a Peruvian birth cohort. Am J Clin Nutr. 2017 Jul;106(1):245-255. doi: 10.3945/ajcn.116.151886. Epub 2017 Jun 7.
PubMed 28592604Platts-Mills JA, Taniuchi M, Uddin MJ, Sobuz SU, Mahfuz M, Gaffar SA, Mondal D, Hossain MI, Islam MM, Ahmed AS, Petri WA, Haque R, Houpt ER, Ahmed T. Association between enteropathogens and malnutrition in children aged 6-23 mo in Bangladesh: a case-control study. Am J Clin Nutr. 2017 May;105(5):1132-1138. doi: 10.3945/ajcn.116.138800. Epub 2017 Apr 5.
PubMed 28381477
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development
- ClinicalTrials.gov ID
- NCT02441426
- Acronym / sponsor ID
- MAL-ED / MAL-ED-47075
- Conditions
- Diarrhea, Malnutrition, Stunting, Wasting, Immune Response, Cognitive Development
- Keywords
- Cognitive development, Diarrheal disease, Enteric infections, Malnutrition, Vaccine Response, Enteropathy, Antibiotic use, Micronutrients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,796 participants (estimated)
- Lead sponsor
- Foundation for the National Institutes of HealthUniversity, hospital or other
- Collaborators
- University of Virginia, Johns Hopkins University, Aga Khan University, Christian Medical College, Vellore, India, Henry M. Jackson Foundation for the Advancement of Military Medicine, Fogarty International Center of the National Institute of Health, Penn State University
- Study start
- Nov 2008
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Bangladesh | – | –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. |
| Brazil | – | –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. |
| India | – | –Birth cohort study community in India is urban, and located in the southern state of Tamil Nadu, specifically in Vellore. |
| Nepal | – | –Birth cohort study community in Nepal is semi-urban, and located in Bhaktapur, approximately 25km from Kathmandu. |
| Pakistan | – | –Birth cohort study community in Pakistan is rural, and located in Naushero Feroze, Sindh. |
| Peru | – | –Birth cohort study community in Peru is rural, and located approximately 15km from Iquitos in Loreto. |
| South Africa | – | –Birth cohort study community in South Africa is rural/peri-urban, and comprised of nine settlements within Limpopo Province. |
| Tanzania | – | –Birth cohort study community in Tanzania is rural, and located within Haydom. |
Who may qualify
- Ages
- 1 minute to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population for the MAL-ED Project is a birth cohort. Pregnant women were identified from their communities, consented and the child will be enrolled.
Key inclusion criteria (1 listed)
- Less than 17 days old.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diarrhea
Time frame: 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
Time frame: 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
Time frame: Cognitive development will be recorded at 6 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
Time frame: Vaccine response will be recorded at 7 months of age.
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Cognitive development
Time frame: Cognitive development will be recorded at 8 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.
Cognitive development
Time frame: Cognitive development will be recorded at 15 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
Time frame: Vaccine response will be recorded at 15 months of age.
Antibody titers will be determined following immunization against rotavirus, polio virus, tetanus toxoid, pertussis toxin and measles vaccines.
Cognitive development
Time frame: 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
Time frame: 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.
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Derived from this study: PubMed 40840991Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.
- Derived from this study: PubMed 31093598Arndt MB, Richardson BA, Mahfuz M, Ahmed T, Haque R, Gazi MA, John-Stewart GC, Denno DM, Scarlett JM, Walson JL; coordination with The Interactions of Malnutrition & Enteric Infections: Consequences for Child Health and Development Project Network. Plasma Fibroblast Growth Factor 21 Is Associated with Subsequent Growth in a Cohort of Underweight Children in Bangladesh. Curr Dev Nutr. 2019 Mar 30;3(5):nzz024. doi: 10.1093/cdn/nzz024. eCollection 2019 May.
- Derived from this study: PubMed 29684739Colston JM, Ahmed T, Mahopo C, Kang G, Kosek M, de Sousa Junior F, Shrestha PS, Svensen E, Turab A, Zaitchik B; MAL-ED Network. Evaluating meteorological data from weather stations, and from satellites and global models for a multi-site epidemiological study. Environ Res. 2018 Aug;165:91-109. doi: 10.1016/j.envres.2018.02.027. Epub 2018 Apr 21.
- Derived from this study: PubMed 28592604Colston JM, Penataro Yori P, Colantuoni E, Moulton LH, Ambikapathi R, Lee G, Rengifo Trigoso D, Siguas Salas M, Kosek MN. A methodologic framework for modeling and assessing biomarkers of environmental enteropathy as predictors of growth in infants: an example from a Peruvian birth cohort. Am J Clin Nutr. 2017 Jul;106(1):245-255. doi: 10.3945/ajcn.116.151886. Epub 2017 Jun 7.
- Derived from this study: PubMed 28381477Platts-Mills JA, Taniuchi M, Uddin MJ, Sobuz SU, Mahfuz M, Gaffar SA, Mondal D, Hossain MI, Islam MM, Ahmed AS, Petri WA, Haque R, Houpt ER, Ahmed T. Association between enteropathogens and malnutrition in children aged 6-23 mo in Bangladesh: a case-control study. Am J Clin Nutr. 2017 May;105(5):1132-1138. doi: 10.3945/ajcn.116.138800. Epub 2017 Apr 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gottlieb, Ph.D. principal investigator
Fountation for the National Institutes of Health
Roger Glass, M.D. principal investigator
Fogarty International Center of the National Institute of Health
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Malnutrition, run by Foundation for the National Institutes of Health at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bangladesh, Brazil, India, Nepal, Pakistan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea (time frame: Each diarrheal episode willbe recorded for up to 24 months of age.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441426, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.