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.
Age range
18 Years – 35 Years
Sex
FEMALE
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Change of weight in women of reproductive age before and after nutritional intervention
Timeframe: Enrolment to 360 days for non-pregnant cohort, and up to 540 days for pregnant cohort
Height of women of reproductive age before and after nutritional intervention
Timeframe: Enrolment to 360 days for non-pregnant cohort, and up to 540 days for pregnant cohort
Change in BMI of women of reproductive age before and after nutritional intervention
Timeframe: Enrolment to 360 days for non-pregnant cohort, and up to 540 days 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
Timeframe: Enrolment to 360 days for non-pregnant, up to 540 days for pregnant cohort
Validated plasma biomarker (sCD14)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated plasma biomarker (CRP)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated plasma biomarker (AGP)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Hormonal regulators of appetite and satiety (Leptin)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Hormonal regulators of appetite and satiety (Ghrelin)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Hormonal regulators of appetite and satiety (IGF-1)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Hormonal regulators of appetite and satiety (Glucagon-like peptide-2 (GLP-2))
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Micronutrients level in plasma (Ferritin)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Micronutrients level in plasma (Zinc)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden, stool pH
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
15. Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/ enteropathogenic burden) (Myeloperoxidase)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden (neopterin)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden (calprotectin)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden (Dual oxidase 2 (DUOX2)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden (Oxidation-Reduction Potential (Redox potential))
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Validated fecal biomarkers of health status including mediators of growth, systemic inflammation, gut inflammation/enteropathogenic burden Lipocalin 2 (Lcn2)
Timeframe: Enrolment to 360 days for non-pregnant and children, up to 540 days for pregnant cohort
Pregnancy-related change in weight
Timeframe: Enrolment to pregnancy termination and three months post-birth