NCT05862363 The Maternal EED Study

Eligibility & Interventions

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This trial targets 180 participants in total. It began in 2023-01-02 with a primary completion date of 2026-12-31.

Brief Summary

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

Inclusion Criteria: Inclusion criteria for pregnant low-BMI women 1. Bangladeshi female, age 18-35 years 2. BMI 20-24.9 kg/m2 3. Middle-upper socioeconomic class (≥ $11/day family income) 4. Functional dyspepsia 5. Willing to sign the consent form 6. Willing to provide biological samples during the study period of 6 months Inclusion criteria for non-pregnant low-BMI women 1. Bangladeshi female, age 18-35 years 1. BMI \<18.5 kg/m2 2. No antibiotics for 1 month 3. Willing to sign the consent form 4. Willing to undergo endoscopy and biopsy 5. Willing to provide biological samples during the study period of 6 months 6. Willing to receive food supplementation for 3 months Inclusion criteria for normal-BMI non-pregnant women 1. Bangladeshi female, age 18-35 years 2. BMI 20-24.9 kg/m2 3. Middle-upper socioeconomic class (≥ $11/day family income) 4. Functional dyspepsia 5. Willing to sign the consent form 6. Willing to provide biological samples during the study period of 6 months Inclusion criteria for normal-BMI pregnant women 1. Bangladeshi female, age 18-35 years 2. BMI 20-24.9 kg/m2 3. Middle-upper socio-economic class (≥ $11/day family income) 4. Enrolled at the end of first-trimester of pregnancy (before 14 weeks of gestation) 5. Willing to sign the consent form 6. Willing to undergo endoscopy and biopsy 7. Willing to provide biological samples during the study period 8. Willing to let anthropometry and biological sample collection from her newborn for the first 6 months of life Exclusion Criteria: Exclusion criteria for pregnant low-BMI women 1. Received antibiotics during the last one month 2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity 3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for non-pregnant low-BMI women 1. Severe anemia (\<8 g/dl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity 2. Pregnancy, lactation, drug abuse, known psychiatric disorders 3. High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition. Adult participants who fulfill the inclusion criteria and are not excluded through history and clinical examination will undergo following screening tests based on clinical judgement: 1. Chest x-ray 2. Urine for R/E 3. Ultrasonography of whole abdomen 4. Fasting blood glucose/ HbA1c 5. Stool for OBT (occult blood test) 6. Cancer markers (ie. CEA, CA 15.3, CA 19.9) 4. Known allergy to any components of nutrition intervention 5. Nugent Score/Amsel Criteria to exclude bacterial vaginosis: A Nugent score 3-4 is consistent with Bacterial vaginosis (BV). The modified Amsel criteria with a cut-off value of 2 (pH+VD; sensitivity 71%, specificity 90%, accuracy 88% or KOH+VD; sensitivity 75%, specificity 91%, accuracy 89%) might be considered for this purpose20. 6. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for non-pregnant normal-BMI women 1. Received antibiotics during the last one month 2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity 3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days Exclusion criteria for pregnant normal-BMI women 1. Multiple pregnancy (carrying two or more fetuses) 2. Threatened abortion, persistent pervaginal bleeding, or cervical incompetence 3. History of three or more consecutive abortions 4. History of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy 5. Active disease/complications requiring acute phase treatment in a hospital 6. Tuberculosis 7. Severe anemia (Hb concentration \< 8 mg/dl) 8. Antibiotic use (ongoing or within last two weeks before the onset of intervention) 9. Taking medications such as insulin, thyroid hormones, glucocorticoids 10. Chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy, or any congenital disorder or other diseases which could impede compliance with the study protocol 11. Known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder 12. Having known history of allergy to the therapeutic agents 13. Having a plan to move or deliver outside the study area 14. Known allergy to any components of nutrition intervention.

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