Undernutrition among women of reproductive age is more common in South Asia than in any other region. In South Asia, the prevalence of maternal undernutrition varies between 10 and 40%. There is a scarcity of data on the contribution of small intestinal (SI) microbiota to pathogenesis of Environmental Enteric Dysfunction (EED) of malnutrition, as it is difficult to obtain gut biopsy specimens from malnourished individuals, especially children. The Bangladesh Environmental Enteric Dysfunction (BEED) study, involving participants who live in an urban slum (Mirpur) in Dhaka, provided an opportunity to examine the role of the duodenal microbiota in the pathogenesis of EED in children and also performed esophagogastroduodenoscopy (EGD) on thirty-eight 18-45-year-old malnourished (BMI\<18.5 kg/m2) women residing in the same resource-poor setting of Mirpur, Dhaka who failed to respond to an egg/milk/micronutrients- based nutritional intervention comparable to that given to children. In this intervention component, beginning at the end of the first trimester, low-BMI (\<18.5 kg/m2) pregnant women (aged 18-35 years) will be randomly assigned to receive either Microbiota-directed Balanced Energy Protein (MD-BEP) or Ready-to-Use-Supplementary Food Balanced Energy Protein (RUSF-BEP) for the duration of their pregnancy and during the first 3 postnatal months, in addition to standard antenatal care. A parallel cohort of age-matched normal-BMI pregnant women who will not receive any nutritional intervention will serve as a reference control group.
Bangladeshi female, age 18-35 years
BMI 20-24.9 kg/m2
Middle-upper socioeconomic class (≥ $11/day family income)
Functional dyspepsia
Received antibiotics during the last one month
Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity
Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days
Severe anemia (<8 g/dl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity
Parallel
Microbiota-directed balanced energy protein (MD-BEP)
Dietary supplementPrototypes for nutritional interventions that are composed of locally available, affordable, culturally acceptable complementary foods commonly consumed in Bangladesh have recently been developed.
Ready-to-use supplementary food-balanced energy protein (RUSF-BEP)
Dietary supplementRUSF-BEP is composed of rice, lentil, sugar, soybean oil, and skimmed milk powder mixed with vitamin-mineral premix. MD-BEP is composed of chickpea flour, peanut flour, soy flour, green banana pulp, sugar, soybean oil, and vitamin-mineral premix. The results from previous studies support the notion that repair of impaired gut microbial community development could represent a new therapeutic concept for restoring healthy growth. RUSF-BEP will be given to one arm of low-BMI women of reproductive age and low-BMI pregnant women.
Esophagogastroduodenoscopy (EGD)
Procedure/SurgeryAim 1A consists of performing EGD to women with low-BMI and normal BMI women with function dyspepsia. In order to enroll 30 participants with normal duodenal mucosal histology, we are planning to perform EGD on 100 healthy women (BMI 20-24.9 kg/m2) of childbearing age who have been referred for evaluation of functional dyspepsia. Undernourished low-BMI (\<18.5kg/m2; 18-35 years) women of childbearing age will be enrolled from Bauniabadh and adjacent slum area of Mirpur, Dhaka and EGD will be performed among 60 women. A total of 6-8 biopsy samples from SI and a dry duodenal aspirate will be collected for biopsy, histochemical and immunocytochemical analysis.
Counselling and follow-up
BehavioralNormal BMI pregnant women will be counseled and followed up as per standard guidelines and will be provided routine antenatal care.
Change of weight in women of reproductive age before and after nutritional intervention
In this study, nutritional status will be assessed through anthropometry. Body weight will be collected in kg using a standard weighing machine, and determined at the time of enrolment for all groups, days 30, 60, 90, 120, 180, 210, 270, and 360 for non-pregnant cohort; and days 30, 60, 90, 120, 164, 178, 180, 210, 280, 360, 390, 450, and 540 for pregnant cohort.
Height of women of reproductive age before and after nutritional intervention
In this study, nutritional status will be assessed through anthropometry. Height will be collected in centimeters using stadiometer. Anthropometry will be collected at the time of enrolment for all groups, days 30, 60, 90, 120, 180, 210, 270, and 360 for non-pregnant cohort; and days 30, 60, 90, 120, 164, 178, 180, 210, 280, 360, 390, 450, and 540 for pregnant cohort.
Change in BMI of women of reproductive age before and after nutritional intervention
In this study, nutritional status will be assessed through anthropometry. Body weight in kilogram and height in cm will be determined at the time of enrolment for all groups, days 30, 60, 90, 120, 180, 210, 270, and 360 for non-pregnant cohort; and days 30, 60, 90, 120, 164, 178, 180, 210, 280, 360, 390, 450, and 540 for pregnant cohort.
Change in body composition of total fat and fat-free mass of women of reproductive age before and after nutritional intervention before and after nutritional intervention
Bioelectric Impedance Analysis (BIA) will be used to measure total fat and fat-free mass before, during and after the intervention. BIA is a method of assessing the body composition by measuring the body fat in relation to lean body mass. It is an integral part of a health and nutrition assessment. BIA will be used to measure total fat and fat-free mass before and after intervention with each of the three arms. 60 low-BMI women (18-35 years) provided with MD-BEP/RUSF-BEP intervention, with an age-matched cohort of 30 healthy (normal-BMI) women and subsequent serial fecal and plasma sampling (without nutritional intervention) serving as a control group will be selected for this analysis. Data will be collected on days 1, 180, and 360 days for non-pregnant women and days 0, 180, 360, and 540 days for pregnant women, and the unit of measurement will be the percentage of fat.
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Washington University School of Medicine
Collaborator
Bangladesh Specialized Hospital
Collaborator
Sheikh Russel National Gastroliver Institute & Hospital
Collaborator
