The Maternal EED Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

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.

Eligibility criteria

Qualifiers

Bangladeshi female, age 18-35 years

BMI 20-24.9 kg/m2

Middle-upper socioeconomic class (≥ $11/day family income)

Functional dyspepsia

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Microbiota-directed balanced energy protein (MD-BEP)
  • Ready-to-use supplementary food-balanced energy protein (RUSF-BEP)
  • Esophagogastroduodenoscopy (EGD)
  • Counselling and follow-up

Treatment groups

180 Participants
are divided into 4 treatment groups

Sponsors and collaborators

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