The Bangladesh Environmental Enteric Dysfunction (BEED) Study

Environmental enteric dysfunction (EED), a sub-acute inflammatory condition of the small intestinal mucosa of unclear etiology, has been associated with a variety of environmental exposures and host factors and is implicated in growth faltering. Linear growth faltering usually occurs within the first two years of life and in most of the cases is irreversible demanding early diagnosis for treatment to be successful. The objectives of 'The Bangladesh Environmental Enteric Dysfunction Study (BEED)' are to investigate role of EED in malnutrition, examine the biology of EED to identify common biological pathways for potential interventions, to validate a system for histological scoring for EED and test the effectiveness of nutritional interventions in improving the growth parameters in children with stunting and or EED. In Bangladesh, participants are recruited from two age groups; a child cohort and a malnourished an adult cohort. In addition, two control groups are recruited for comparison consisting of a) children that are undergoing endoscopy as a part of their clinical care at the University of Virginia Health system (UVAHS) and b) an adult well-nourished control group recruited from the Gastroenterology Outpatient Department of Dhaka Medical College and Hospital in Bangladesh. The description of the study design and procedures of the study can be obtained from Mahfuz M, Das S, Mazumder RN, et al., 2017, PMID: 28801442.]]>
Participants enrolled in Bangladesh 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 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), TB, 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 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 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), TB, 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), TB, 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 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 Exclusion criteria for malnourished adults:Meeting any of the following criterions will exclude a subject from study participation Severe anemia (<8 g/dl), TB 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 following screening tests: Chest x-ray, Ultrasonography of whole abdomen, Fasting blood glucose, Stool for OBT (occult blood test), Cancer markers: Carcino-embryonic antigen (CEA), Ca-19.9, Ca-125 (female) Known allergy to any components of nutrition intervention Participants enrolled at UVA Health System, Virginia Inclusion Age 12 months to 18 years Male or female Scheduled for endoscopy for clinical care Approved by pediatric clinician as study candidate Exclusion Parent or guardian unwilling to consent ]]>
Enrollment of participants began in May 2017 in Bangladesh, following which undernourished children and adults received nutrition and health interventions. Biological samples are collected before and after intervention. Participant that do not respond to interventions undergo endoscopy after screening and consent. Recruitment of children undergoing endoscopy as part of clinical care at UVAHS began in June of 2017 to obtain additional endoscopic biopsy samples to determine if changes in small bowel histopathology or in plasma metabolome are involved in the pathogenesis and consequences of (EED).]]>