The Bangladesh Environmental Enteric Dysfunction Study (NCT02812615) | Clinical Trial Compass
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The Bangladesh Environmental Enteric Dysfunction Study
Bangladesh1,575 participantsStarted 2016-07-16
Plain-language 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.
Who can participate
Age range
12 Months – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for stunted children: All of the following criteria must be met for a subject to be eligible to participate in the study-
* Parent(s) willing to sign consent form
* Child age 12-18 months
* LAZ \< -2
* Parent(s) willing to bring child to the study site every day for 3 months for nutritional therapy
* Parents willing to have child undergo laboratory investigations and upper GI endoscopy and biopsy if the child fails to respond to nutritional therapy
Inclusion criteria for children who are at risk of stunting: All of the following criteria must be met for a subject to be eligible to participate in the study -
* Parent(s) willing to sign consent form
* Child age 12-18 months
* LAZ between \<-1 to -2
* Parent(s) willing to bring child to the study site every day for 2 months for nutritional therapy
* Parents willing to have child undergo endoscopy and biopsy if the child fails to respond to nutritional therapy
Inclusion criteria for malnourished adults: All of the following criteria must be met for a subject to be eligible to participate in the study -
* Willing to sign consent form
* Age 18-45 years
* BMI \< 18.5
* Willing to visit the study site every day for 2 months for nutritional therapy
* Willing to undergo endoscopy and biopsy if he/she fails to respond to nutritional therapy
Selection criteria for adult controls:
An equal number of age and sex matched adult controls will be enrolled form the subjects with functional dyspepsi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Length for Age Z score
Timeframe: baseline and 3 months
2
Change in Body Mass Index
Timeframe: baseline and 2 months
Trial details
NCT IDNCT02812615
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh