The Bangladesh Environmental Enteric Dysfunction Study

NCT02812615 | Unknown

• 1 other identifier: PR-16007
• Study Type: interventional
• Target: 1,575
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Environmental Enteric Dysfunction

Outcome Measures

Primary Outcomes (2)

• Change in Length for Age Z score

  For stunted child participants, length and age data will be collected before and after the intervention period (3 months) and changes in length for age Z score will be measured.For at risk of stunting child participants, length and age data will be collected before and after the intervention period (2 months) and changes in length for age Z score will be measured.

  baseline and 3 months

• Change in Body Mass Index

  For malnourished adult participants, height and and weight data will be collected before and after the intervention period (2 months) and changes in Body Mass Index will be measured.

  baseline and 2 months

Secondary Outcomes (19)

• Change in stool Regeneration gene 1 Beta (Reg 1B) biomarker level

  baseline and 3 months

• Change in stool neopterin level

  baseline and 3 months

• Change in stool myeloperoxidase level

  baseline and 3 months

• Change in stool Alpha-1-antitrypsin level

  baseline and 3 months

• Change in stool Calprotectin level

  baseline and 3 months

Study Arms (1)

Malnourished participants

EXPERIMENTAL

After screening the participants for any organic diseases and application of inclusion/exclusion criteria, stunted children, children who are at risk of stunting and malnourished adult cases will receive one egg, 150 ml of milk 6 days a week for 3, 2 and 2 months respectively. Along with that participants will also get Anti-helminthic treatment (Albendazole/Pyrantel Pamoate) and nutritional counselling. Children will get one sachet of multiple micro-nutrient sprinkles per day to be administered at home with the mid-day meal for two months.

Dietary Supplement: Egg; Dietary Supplement: Milk; Drug: Albendazole/Pyrantel Pamoate; Behavioral: Nutritional counselling; Dietary Supplement: Micronutrient sprinkles

Interventions

Egg DIETARY_SUPPLEMENT

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.

Malnourished participants

Milk DIETARY_SUPPLEMENT

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.

Malnourished participants

Albendazole/Pyrantel Pamoate DRUG

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.

Malnourished participants

Nutritional counselling BEHAVIORAL

Parents/caregivers will be given nutritional counselling

Malnourished participants

Micronutrient sprinkles DIETARY_SUPPLEMENT

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

Malnourished participants

Eligibility Criteria

• Age: 12 Months - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Virginia: collaborator
• University of Washington: collaborator
• Dhaka Medical College: collaborator
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator

Study Sites (1)

Mirpur

Dhaka, 1216, Bangladesh

RECRUITING

Related Publications (6)

• Pierce R, Jan NJ, Kumar P, Middleton J, Petri WA, Marie C. Persistent dysbiosis of duodenal microbiota in patients with controlled pediatric Crohn's disease after resolution of inflammation. Sci Rep. 2024 Jun 3;14(1):12668. doi: 10.1038/s41598-024-63299-y.

  PMID: 38830904 DERIVED

• Hossain MS, Begum SMKN, Rahman MM, Parvez M, Mazumder RN, Sarker SA, Hasan MM, Fahim SM, Gazi MA, Das S, Mahfuz M, Ahmed T. Environmental enteric dysfunction and small intestinal histomorphology of stunted children in Bangladesh. PLoS Negl Trop Dis. 2023 Jan 19;17(1):e0010472. doi: 10.1371/journal.pntd.0010472. eCollection 2023 Jan.

  PMID: 36656867 DERIVED

• Chen RY, Kung VL, Das S, Hossain MS, Hibberd MC, Guruge J, Mahfuz M, Begum SMKN, Rahman MM, Fahim SM, Gazi MA, Haque R, Sarker SA, Mazumder RN, Di Luccia B, Ahsan K, Kennedy E, Santiago-Borges J, Rodionov DA, Leyn SA, Osterman AL, Barratt MJ, Ahmed T, Gordon JI. Duodenal Microbiota in Stunted Undernourished Children with Enteropathy. N Engl J Med. 2020 Jul 23;383(4):321-333. doi: 10.1056/NEJMoa1916004.

  PMID: 32706533 DERIVED

• Mahfuz M, Alam MA, Das S, Fahim SM, Hossain MS, Petri WA Jr, Ashorn P, Ashorn U, Ahmed T. Daily Supplementation With Egg, Cow Milk, and Multiple Micronutrients Increases Linear Growth of Young Children with Short Stature. J Nutr. 2020 Feb 1;150(2):394-403. doi: 10.1093/jn/nxz253.

  PMID: 31665385 DERIVED

• Hossain MS, Das S, Gazi MA, Alam MA, Haque NMS, Mahfuz M, Ahmed T, Damman CJ. Association of faecal pH with childhood stunting: Results from a cross-sectional study. BMJ Paediatr Open. 2019 Sep 13;3(1):e000549. doi: 10.1136/bmjpo-2019-000549. eCollection 2019.

  PMID: 31646200 DERIVED

• Mahfuz M, Das S, Mazumder RN, Masudur Rahman M, Haque R, Bhuiyan MMR, Akhter H, Sarker MSA, Mondal D, Muaz SSA, Karim ASMB, Borowitz SM, Moskaluk CA, Barratt MJ, Petri WA, Gordon JI, Ahmed T. Bangladesh Environmental Enteric Dysfunction (BEED) study: protocol for a community-based intervention study to validate non-invasive biomarkers of environmental enteric dysfunction. BMJ Open. 2017 Aug 11;7(8):e017768. doi: 10.1136/bmjopen-2017-017768.

  PMID: 28801442 DERIVED

MeSH Terms

Conditions

Malnutrition; Infections

Interventions

Eggs; Milk; Albendazole; Pyrantel Pamoate

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Dairy Products; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrantel; Thiophenes; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Tahmeed Ahmed, PhD

CONTACT

tahmeed@icddrb.org

Mustafa Mahfuz, MPH

CONTACT

mustafa@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 24, 2016
• Study Start: July 16, 2016
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: February 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)