[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505513":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":50,"centralContacts":54,"locations":64,"responsibleParty":95,"collaborators":97,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":35,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":35,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":129,"overallStatus":67,"whyStopped":35,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",[8,15,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal BMI women","ACTIVE_COMPARATOR","A total of 30 women with functional dyspepsia will be recruited as a control arm of AIM 1A. The women will be recruited who will present with GI symptoms. A total of 100 women will undergo EGD, out of which 30 women will be enrolled based on their diagnosis of functional dyspepsia and willingness to participate in the study.",[13,14],"Procedure: Esophagogastroduodenoscopy (EGD)","Behavioral: Counselling and follow-up",{"label":16,"type":10,"description":17,"interventionNames":18},"Low- BMI women","A total of 60 women from low-socioeconomic status (SES) and with low BMI will be included in the intervention arm of aim A1. They will be recruited based on their willingness to participate and through meeting the inclusion criteria. They will under EGD, including collection of duodenal aspirates and 6-8 biopsy samples. After EGD, 30 participants will receive MD-BEP and 30 will receive RUSF-BEP upon randomization.",[19,20,13,14],"Dietary Supplement: Microbiota-directed balanced energy protein (MD-BEP)","Dietary Supplement: Ready-to-use supplementary food-balanced energy protein (RUSF-BEP)",{"label":22,"type":10,"description":23,"interventionNames":24},"Low-BMI pregnant women","We will recruit 60 pregnant women with low-BMI before 14 weeks of gestation. 30 participants will receive MD-BEP and 30 will receive RUSF-BEP upon randomization. They will be followed to note changes in weight gain, BMI, changes in EED biomarkers, gut microbial community repair, and pregnancy related outcomes.",[19,20,14],{"label":26,"type":10,"description":27,"interventionNames":28},"Normal BMI pregnant women","We will recruit 30 pregnant women with normal-BMI before 14 weeks of gestation. They will be provided with standard antenatal care. They will be followed to note changes in weight gain, BMI, changes in EED biomarkers, gut microbial community repair, and pregnancy related outcomes.",[14],[30,36,40,45],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT","Microbiota-directed balanced energy protein (MD-BEP)","Prototypes for nutritional interventions that are composed of locally available, affordable, culturally acceptable complementary foods commonly consumed in Bangladesh have recently been developed.",[16,22],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Ready-to-use supplementary food-balanced energy protein (RUSF-BEP)","RUSF-BEP is composed of rice, lentil, sugar, soybean oil, and skimmed milk powder mixed with vitamin-mineral premix. MD-BEP is composed of chickpea flour, peanut flour, soy flour, green banana pulp, sugar, soybean oil, and vitamin-mineral premix. The results from previous studies support the notion that repair of impaired gut microbial community development could represent a new therapeutic concept for restoring healthy growth. RUSF-BEP will be given to one arm of low-BMI women of reproductive age and low-BMI pregnant women.",[16,22],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"PROCEDURE","Esophagogastroduodenoscopy (EGD)","Aim 1A consists of performing EGD to women with low-BMI and normal BMI women with function dyspepsia. In order to enroll 30 participants with normal duodenal mucosal histology, we are planning to perform EGD on 100 healthy women (BMI 20-24.9 kg\u002Fm2) of childbearing age who have been referred for evaluation of functional dyspepsia. Undernourished low-BMI (\\\u003C18.5kg\u002Fm2; 18-35 years) women of childbearing age will be enrolled from Bauniabadh and adjacent slum area of Mirpur, Dhaka and EGD will be performed among 60 women. A total of 6-8 biopsy samples from SI and a dry duodenal aspirate will be collected for biopsy, histochemical and immunocytochemical analysis.",[16,9],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":35},"BEHAVIORAL","Counselling and follow-up","Normal BMI pregnant women will be counseled and followed up as per standard guidelines and will be provided routine antenatal care.",[16,22,26,9],[51],{"name":52,"affiliation":5,"role":53},"Md. Shabab Hossain, MBBS","PRINCIPAL_INVESTIGATOR",[55,61],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"M. A. Salam Khan","CONTACT","+880-2-9827001-10","3206","salamk@icddrb.org",{"name":52,"role":57,"phone":58,"phoneExt":62,"email":63},"2305","dr.shabab@icddrb.org",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)","RECRUITING","Dhaka","Dhaka Division","1212","Bangladesh","BD",{"type":74,"coordinates":75},"Point",[76,77],90.40744,23.7104,{"lat":77,"lon":76},[80,82,84,87,89,91,93],{"name":52,"role":57,"phone":81,"phoneExt":62,"email":63},"+88 02 2222 77 001-10",{"name":83,"role":53,"phone":35,"phoneExt":35,"email":35},"Md. Shabab Hossain",{"name":85,"role":86,"phone":35,"phoneExt":35,"email":35},"Tahmeed Ahmed","SUB_INVESTIGATOR",{"name":88,"role":86,"phone":35,"phoneExt":35,"email":35},"Mustafa Mahfuz",{"name":90,"role":86,"phone":35,"phoneExt":35,"email":35},"Shafiqul Alam Sarker",{"name":92,"role":86,"phone":35,"phoneExt":35,"email":35},"M Masudur Rahman",{"name":94,"role":86,"phone":35,"phoneExt":35,"email":35},"S M Khodeza Nahar Begum",{"type":96,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[98,100,103],{"name":99,"class":6},"Washington University School of Medicine",{"name":101,"class":102},"Bangladesh Specialized Hospital","UNKNOWN",{"name":104,"class":102},"Sheikh Russel National Gastroliver Institute & Hospital","100505513","the-maternal-eed-study-100505513",false,"NCT05862363","The Maternal EED Study","Small Intestinal Microbiota of Low Body Mass Index (BMI) & Normal BMI Women of Reproductive Age and Microbiota-directed Balanced Energy Protein (MD-BEP) Supplementation in Maternal Environmental Enteric Dysfunction (EED)","Inclusion Criteria:\n\nInclusion criteria for pregnant low-BMI women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socioeconomic class (≥ $11\u002Fday family income)\n4. Functional dyspepsia\n5. Willing to sign the consent form\n6. Willing to provide biological samples during the study period of 6 months\n\nInclusion criteria for non-pregnant low-BMI women 1. Bangladeshi female, age 18-35 years\n\n1. BMI \\\u003C18.5 kg\u002Fm2\n2. No antibiotics for 1 month\n3. Willing to sign the consent form\n4. Willing to undergo endoscopy and biopsy\n5. Willing to provide biological samples during the study period of 6 months\n6. Willing to receive food supplementation for 3 months\n\nInclusion criteria for normal-BMI non-pregnant women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socioeconomic class (≥ $11\u002Fday family income)\n4. Functional dyspepsia\n5. Willing to sign the consent form\n6. Willing to provide biological samples during the study period of 6 months\n\nInclusion criteria for normal-BMI pregnant women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socio-economic class (≥ $11\u002Fday family income)\n4. Enrolled at the end of first-trimester of pregnancy (before 14 weeks of gestation)\n5. Willing to sign the consent form\n6. Willing to undergo endoscopy and biopsy\n7. Willing to provide biological samples during the study period\n8. Willing to let anthropometry and biological sample collection from her newborn for the first 6 months of life\n\nExclusion Criteria:\n\nExclusion criteria for pregnant low-BMI women\n\n1. Received antibiotics during the last one month\n2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity\n3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for non-pregnant low-BMI women\n\n1. Severe anemia (\\\u003C8 g\u002Fdl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity\n2. Pregnancy, lactation, drug abuse, known psychiatric disorders\n3. 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:\n\n   1. Chest x-ray\n   2. Urine for R\u002FE\n   3. Ultrasonography of whole abdomen\n   4. Fasting blood glucose\u002F HbA1c\n   5. Stool for OBT (occult blood test)\n   6. Cancer markers (ie. CEA, CA 15.3, CA 19.9)\n4. Known allergy to any components of nutrition intervention\n5. Nugent Score\u002FAmsel 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.\n6. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for non-pregnant normal-BMI women\n\n1. Received antibiotics during the last one month\n2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity\n3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for pregnant normal-BMI women\n\n1. Multiple pregnancy (carrying two or more fetuses)\n2. Threatened abortion, persistent pervaginal bleeding, or cervical incompetence\n3. History of three or more consecutive abortions\n4. History of gestational diabetes, macrosomia, gestational hypertension, preeclampsia\u002Feclampsia in a prior pregnancy\n5. Active disease\u002Fcomplications requiring acute phase treatment in a hospital\n6. Tuberculosis\n7. Severe anemia (Hb concentration \\\u003C 8 mg\u002Fdl)\n8. Antibiotic use (ongoing or within last two weeks before the onset of intervention)\n9. Taking medications such as insulin, thyroid hormones, glucocorticoids\n10. 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\n11. Known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder\n12. Having known history of allergy to the therapeutic agents\n13. Having a plan to move or deliver outside the study area\n14. Known allergy to any components of nutrition intervention.",true,"FEMALE","18 Years","35 Years",{"count":117,"type":118},180,"ESTIMATED","INTERVENTIONAL",[121],"NA","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\\\u003C18.5 kg\u002Fm2) women residing in the same resource-poor setting of Mirpur, Dhaka who failed to respond to an egg\u002Fmilk\u002Fmicronutrients- based nutritional intervention comparable to that given to children. In this intervention component, beginning at the end of the first trimester, low-BMI (\\\u003C18.5 kg\u002Fm2) 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.",[124,125,126,127,128],"Environmental Enteric Dysfunction (EED)","Malnutrition","Women of Reproductive Age","Gut Microbiota","Balanced Energy Protein (BEP)",[130,131,132,125,133],"Balanced energy protein (BEP)","Environmental enteric dysfunction (EED)","Gut microbiota","Women of reproductive age","2025-05-12",{"date":136,"type":137},"2025-05-14","ACTUAL",{"date":139,"type":137},"2023-01-02",{"date":141,"type":118},"2026-12-31",{"name":5,"class":6},1]