The Bangladesh Environmental Enteric Dysfunction Study
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This is a community-based intervention study which will be undertaken at Mirpur, Dhaka,
Bangladesh. Participants will be recruited from two age groups: a child cohort (age 12 to 18
months) and an adult cohort (age 18 to 45 years). The child cohort will consist of stunted
children (length for age Z score, LAZ < -2), children who are at risk of stunting (length for
age Z score <-1 to -2) and child controls. The adult cohort will consist of malnourished
adult cases (Body Mass Index <18.5) and adult controls. After screening the participants for
any organic diseases and application of inclusion/exclusion criteria, they will receive
nutrition interventions. Participants eligible for study will be tested for potential bio
markers of environmental enteropathy (stool, urine and serum) once before and once after the
nutritional intervention. Participants who will fail to respond to nutritional therapy
(measured by anthropometric assessment) will become candidates for upper gastrointestinal
endoscopy with biopsy. The study will include duodenal biopsies from a control group of
children from University of Virginia Hospital in Charlottesville, Virginia who will undergo
upper GI endoscopy as part of their clinical care as per the standard clinical protocol
followed at the hospital. Adult controls (BMI > 18.5) for endoscopy will be collected from
international centre for diarrhoeal disease research,Bangladesh staff clinic, Dhaka Medical
College and Hospital (DMCH), Dhaka and Bangabandhu Sheikh Mujib Medical University (BSMMU),
Dhaka.
Phase:
N/A
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Bill and Melinda Gates Foundation Dhaka Medical College University of Virginia University of Washington
Treatments:
Albendazole Micronutrients Pyrantel Pyrantel Pamoate Trace Elements