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The Maternal EED Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Nov 30, 2025 to Dec 31, 2026
    • Start date: Apr 15, 2023 to Jan 2, 2023
    • Site details revised
    v4
  2. Notable Primary endpoints revised (21)v3 Show 4 more changesShow less
    • Primary and study completion dates: Sep 30, 2025 to Nov 30, 2025
    • Interventions: Counselling and follow-up (Behavioral), Esophagogastroduodenoscopy (EGD) (Procedure), Microbiota-directed complementary food (MDCF)-2… to Counselling and follow-up (Behavioral), Esophagogastroduodenoscopy (EGD) (Procedure), Microbiota-directed balanced energy protein (MD-BEP)…
    • Eligibility criteria expanded, about 326 words
    • Study description expanded, about 236 words
  3. Notable Primary endpoints revised (21)
    • Study description expanded, about 8 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05862363
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: Washington University School of Medicine, Bangladesh Specialized Hospital, Sheikh Russel National Gastroliver Institute & Hospital
Conditions
(from sponsor)
Environmental Enteric Dysfunction (EED), Malnutrition, Women of Reproductive Age, Gut Microbiota, Balanced Energy Protein (BEP)
Related terms Malnutrition
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov