The Bangladesh Environmental Enteric Dysfunction Study

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

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 dyspepsia (FD) with apparently normal health (normal BMI) and absence of organic diseases. FD subjects will be identified from the Gastroenterology outpatient department of Dhaka Medical College Hospital and international centre for diarrhoeal disease research, Bangladesh staff clinic who will undergo upper GI endoscopy for evaluation of dyspepsia and have normal endoscopic findings. Dyspepsia will be defined by pre-defined criteria (Rome III criteria) by a structured questionnaire which has been translated and validated in Bengali.

Exclusion Criteria:

Exclusion criteria for stunted children: Meeting any of the following criteria will exclude a subject from study participation -

• Severe acute malnutrition (SAM), severe anemia (<8 g/dl), tuberculosis, other chronic diseases or any congenital disorder or deformity

• Diarrhoea: Ongoing episode of diarrhoea, history of persistent diarrhoea in the past month or history of acute diarrhoea in the past 7 days

• Known allergy to eggs or milk or milk intolerance

Exclusion criteria for children who are at risk of stunting: Meeting any of the following criteria will exclude a subject from study participation -

• Severe acute malnutrition (SAM), severe anemia (<8 g/dl), tuberculosis, other chronic diseases or any congenital disorder or deformity

• Diarrhoea: Ongoing episode of diarrhoea, history of persistent diarrhoea in the past month or history of acute diarrhoea in the past 7 days

• Known allergy to eggs or milk or milk intolerance

Exclusion criteria for malnourished adults: Meeting any of the following criterions will exclude a subject from study participation-

• Severe anemia (<8 g/dl), tuberculosis and other chronic diseases including diabetes mellitus or any congenital disorder or deformity

• Pregnant women, lactating women, drug abusers, known psychiatric disorders

• High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition. Adult participants who fulfilled the inclusion criteria and not excluded through history and clinical examination based exclusion criteria will undergo screening tests for confirmation.