The Bangladesh Environmental Enteric Dysfunction Study

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.

Conditions

• Malnutrition
• Infection

Interventions

DIETARY_SUPPLEMENT

Egg

After enrollment, participants will receive one large egg 6 days a week for 3, 2 and 2 months for stunted children, children at risk of stunting, and malnourished adults, respectively.

DIETARY_SUPPLEMENT

Milk

After enrollment, participants will receive 150ml of milk 6 days a week for 3, 2 and 2 months for stunted children, children at risk of stunting, and malnourished adults, respectively.

DRUG

Albendazole/Pyrantel Pamoate

As per the national guidelines, treatment will be provided based with 200 mg of Albendazole or 10mg/kg Pyrantel Pamoate single dose if the participants have not been treated for helminths in the preceding three months.

BEHAVIORAL

Nutritional counselling

Parents/caregivers will be given nutritional counselling

DIETARY_SUPPLEMENT

Micronutrient sprinkles

For the child cohort, one sachet of multiple micro-nutrient sprinkles per day to be administered with the mid-day meal for two months

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Dhaka Medical College

  collaborator OTHER

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-16

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• Bangladesh

Study Locations