Actively Recruiting
The Maternal EED Study
Led by International Centre for Diarrhoeal Disease Research, Bangladesh · Updated on 2025-05-14
180
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
I
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Maternal EED Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 35 years
- Willing to sign the consent form and provide biological samples during the study
- For pregnant low-BMI women: BMI 20-24.9 kg/m2, middle-upper socioeconomic status (≥ $11/day), functional dyspepsia
- For non-pregnant low-BMI women: BMI <18.5 kg/m2, no antibiotics for 1 month, willing to undergo endoscopy and biopsy, willing to receive food supplementation for 3 months
- For normal-BMI non-pregnant women: BMI 20-24.9 kg/m2, middle-upper socioeconomic status (≥ $11/day), functional dyspepsia
- For normal-BMI pregnant women: BMI 20-24.9 kg/m2, middle-upper socioeconomic status (≥ $11/day), enrolled at end of first trimester (before 14 weeks gestation), willing to undergo endoscopy and biopsy, willing to allow anthropometry and biological sample collection from newborn for 6 months
You will not qualify if you...
- Recent antibiotic use within the last month (pregnant low-BMI and non-pregnant normal-BMI women)
- Presence of chronic diseases including diabetes mellitus, tuberculosis, congenital disorders, or deformities
- Ongoing or recent episodes of diarrhea within the past month or acute diarrhea within 7 days
- Severe anemia (hemoglobin <8 g/dl)
- Pregnancy or lactation (for non-pregnant low-BMI women)
- Drug abuse, psychiatric disorders, or known allergy to nutrition intervention components
- High suspicion or diagnosis of cancer or other acute/chronic diseases causing malnutrition
- Bacterial vaginosis as indicated by Nugent score or Amsel criteria
- Multiple pregnancy, threatened abortion, or history of multiple consecutive abortions (pregnant normal-BMI women)
- Use of medications such as insulin, thyroid hormones, glucocorticoids
- Chronic diseases including hypertension, heart, lung, kidney, liver, pancreatic, gastrointestinal, immunological diseases, malignancy
- Plans to move or deliver outside the study area
- Serious psychiatric or behavioral disorders such as schizophrenia or bipolar disorder
AI-Screening
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Trial Site Locations
Total: 1 location
1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, Bangladesh, 1212
Actively Recruiting
Research Team
M
M. A. Salam Khan
CONTACT
M
Md. Shabab Hossain, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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