UnknownNot Applicable

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 range12 Months – 45 Years

SexALL

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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…

What they're measuring

Change in Length for Age Z score

Timeframe: baseline and 3 months

Change in Body Mass Index

Timeframe: baseline and 2 months

Trial details

NCT IDNCT02812615

SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Contact for this trial

Tahmeed Ahmed, PhD

tahmeed@icddrb.org