Bangladesh Environmental Enteric Dysfunction (BEED) study: protocol for a community-based intervention study to validate non-invasive biomarkers of environmental enteric dysfunction

Abstract

IntroductionEnvironmental enteric dysfunction (EED) is a subacute inflammatory condition of the small intestinal mucosa with unclear aetiology that may account for more than 40% of all cases of stunting. Currently, there are no universally accepted protocols for the diagnosis, treatment and ultimately prevention of EED. The Bangladesh Environmental Enteric Dysfunction (BEED) study is designed to validate non-invasive biomarkers of EED with small intestinal biopsy, better understand disease pathogenesis and identify potential therapeutic targets for interventions designed to control EED and stunting.Methods and analysisThe BEED study is a community-based intervention where participants are recruited from three cohorts: stunted children aged 12–18 months (length for age Z-score (LAZ) <−2), at risk of stunting children aged 12–18 months (LAZ <−1 to −2) and malnourished adults aged 18–45 years (body mass index <18.5 kg/m2). After screening, participants eligible for study provide faecal, urine and plasma specimens to quantify the levels of candidate EED biomarkers before and after receiving a nutritional intervention. Participants who fail to respond to nutritional therapy are considered as the candidates for upper gastrointestinal endoscopy with biopsy. Histopathological scoring for EED will be performed on biopsies obtained from several locations within the proximal small intestine. Candidate EED biomarkers will be correlated with nutritional status, the results of histochemical and immunohistochemical analyses of epithelial and lamina propria cell populations, plus assessments of microbial community structure.Ethics and disseminationEthics approval was obtained in all participating institutes. Results of this study will be submitted for publication in peer-reviewed journals.Trial registration numberClinicalTrials.gov ID: NCT02812615. Registered on 21 June 2016.

Association of Plasma Low-Density Lipoprotein Receptor-Related Protein-1 (LRP1) with Undernutrition: A Case-Control Study in Bangladeshi Adults

“…Among the participants nearly one-third was male. The median (IQR) ages of the healthy and undernourished participants were 24 (19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) 5% undernourished participants were smokers and smoking status signi cantly (p < 0.05) differ between these two study groups. Almost similar numbers of healthy and undernourished participants were addicted with different types of substances such as betel leaf, areca nut, slaked lime.…”

“…A group of Bangladeshi adults were recruited in a case-control manner from our ongoing "Bangladesh Environmental Enteric Dysfunction (BEED)" study. The detailed study protocol has been published elsewhere [22]. The case group was comprised of 135 undernourished participants (BMI < 18.5 kg/m 2 ).…”

Helicobacter pylori infection is associated with fecal biomarkers of environmental enteric dysfunction but not with the nutritional status of children living in Bangladesh

“…Exclusion criteria for enrollment in BEED study are: severe acute malnutrition, severe anemia, tuberculosis, presence of any congenital anomaly or deformity, suffering from diarrhoea or history of persistent diarrhoea in the preceding month, another family member already enrolled in the BEED study, and presence of any severe or chronic disease. The methodology of BEED study has been published previously [38].…”

Proof-of-concept study of the efficacy of a microbiota-directed complementary food formulation (MDCF) for treating moderate acute malnutrition

“…Procedures for data management at icddr,b have been previously described [9]. An Excel-based program will be used for scheduling data and sample collection from each participant.…”