[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"environmental-enteric-dysfunction-eed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:environmental-enteric-dysfunction-eed":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100603305","phase-2-maternal-probiotic-intervention-to-improve-gut-health---trial-ii---burkina-faso-mpigh-ii-100603305",false,"NCT07134790","Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)","Ability of the Probiotic VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: A Proof-of-Concept and Phase II Randomized Placebo-Controlled Trial in Bangladesh, Pakistan, Zambia, and Burkina Faso.","MPIGH-II","All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.\n\nInclusion criteria\n\n1. Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \\[GA\\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent\n\n   AND\n2. Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.\n\n   AND\n3. Presence of any of the following WASH conditions -\n\n1\\. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing\n\nExclusion criteria\n\nPotential participants will not be enrolled if they:\n\n1. have MUAC ≥30 cm\n2. are carrying more than one fetus (i.e., multiple pregnancy)\n3. have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days\n4. have fever or an active infection\n5. have taken antibiotics or probiotics in the preceding 14 days\n6. have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days\n7. have severe anemia as determined using finger stick Hb \\\u003C 8 g\u002Fdl\n8. have a history of chronic digestive disease\n9. have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)\n10. have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)\n11. have known drug hypersensitivity\u002Fallergy\u002Fintolerance\n12. have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy\n13. are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation\n14. have a plan to observe fast any time during the intervention period\n15. have a plan to leave the study area within the follow-up period\n16. are participating in any other interventional trial\n17. belong to a household from which another woman is already enrolled in the study\n\nbut may be enrolled if\u002Fwhen these disqualifiers have expired.","FEMALE","18 Years",{"count":20,"type":21},144,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.\n\nKnowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrated a high prevalence of EED among undernourished women. Intestinal histopathology was abnormal in more than 80% of women. We postulate that growth retardation in utero is a consequence of EED in the mother during pregnancy and lactation. This leads to systemic inflammation, which lead to disadvantageous partitioning of nutrients, and reduced nutrient availability.\n\nRelevance: This trial will explore the conceptual framework that a probiotic or live biotherapeutic product that can improve the composition of gut microbiota, can also displace enteropathogens and reduce biomarkers of intestinal inflammation to promote gut health. This will restore healthy microbial signaling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.\n\nObjectives: The primary objective is to assess if administration of oral vancomycin followed by VE818 to pregnant women colonized with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo.\n\nMethods: Pregnant women will be recruited in antenatal clinics and in the community in Matlab in Bangladesh, Bobo-Dioulasso in Burkina Faso, Matiari in Pakistan, and Lusaka in Zambia. Study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explained in detail and written consent will be taken before enrollment. Those women who give consent to participation will undergo a screening process which will check if any exclusion criteria are fulfilled. After consent and screening they will be randomized into either of the three arms: intervention arm (oral vancomycin followed by VE818), placebo-control arm (oral vancomycin followed by placebo), or observation-only arm. The allocation sequence will be generated by the trial statistician using a code with block permutation. The participant will remain free to withdraw at any time from the trial without giving reasons and without prejudicing her further treatment. Biological samples, including blood, saliva, urine, stool, vaginal swab, and intestinal luminal contents through CapScan. CapScan is a non-invasive device (capsule) that collects gastrointestinal samples along the gastrointestinal tract following ingestion and passes into stool.\n\nOutcome measures\u002Fvariables: The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to 35th day, +2 from the first dose of oral vancomycin.\n\nThe 11 enteropathogen targets will be detected by customized real-time quantitative PCR-based TaqMan Array Cards (TAC-qPCR) and include the following organisms: Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli (E. coli), Enteropathogenic E. coli, Enterotoxigenic E. coli, Plesiomonas, Shigella\\_Enteroinvasive E. coli (EIEC), Salmonella and Klebsiella pneumoniae.",[27],"Environmental Enteric Dysfunction (EED)","RECRUITING","2025-11-14",{"date":31,"type":32},"2025-11-17","ACTUAL",{"date":34,"type":32},"2025-07-30",{"date":36,"type":21},"2027-06-07",{"name":38,"class":39},"University Ghent","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":15,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":40},"100608890","phase-2-maternal-probiotic-intervention-to-improve-gut-health-trial-ii-pakistan-100608890","NCT07207434","Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan","Ability of VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept and Phase II Randomized Placebo-controlled Trial in Bangladesh, Pakistan, Zambia and Burkina Faso","Inclusion criteria\n\n* Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \\[GA\\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent\n* Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.\n* Presence of any of the following WASH conditions -\n\n  1. use surface water, unimproved water, or limited water for drinking; OR\n  2. use surface water, unimproved water, or limited water for cooking; OR\n  3. use surface water, unimproved water, or limited water for washing utensils; OR\n  4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR\n  5. lack facility or have limited facility for handwashing\n\nExclusion criteria\n\nPotential participants will not be enrolled if they:\n\n* have MUAC ≥30 cm\n* are carrying more than one fetus (i.e., multiple pregnancy)\n* have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days\n* have fever or an active infection\n* have taken antibiotics or probiotics in the preceding 14 days\n* have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days\n* have severe anemia as determined using finger stick Hb \\\u003C 8 g\u002Fdl\n* have a history of chronic digestive disease\n* have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)\n* have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)\n* have known drug hypersensitivity\u002Fallergy\u002Fintolerance\n* have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy\n* are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation\n* have a plan to observe fast any time during the intervention period\n* have a plan to leave the study area within the follow-up period\n* are participating in any other interventional trial\n* belong to a household from which another woman is already enrolled in the study\n* but may be enrolled if\u002Fwhen these disqualifiers have expired.","49 Years",{"count":20,"type":21},[24],"Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.\n\nRelevance: This trial aims to investigate the concept that a probiotic or live biotherapeutic product, capable of improving gut microbiota composition, can also displace enteropathogens and reduce biomarkers of intestinal inflammation, thereby promoting gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.\n\nObjectives: The primary objective is to assess if administration of oral vancomycin followed by VE818 to pregnant women colonised with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo.\n\nMethods: Pregnant women will be recruited from the community of Matiari in Pakistan. The study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explained in detail, and written consent will be taken before enrollment. Those women who give consent to participation will undergo a screening process, which will check if any exclusion criteria are fulfilled. After consent and screening, they will be randomised into one of the three arms: intervention arm (oral vancomycin followed by VE818), placebo-control arm (oral vancomycin followed by placebo), or observation-only arm. The allocation sequence will be generated by the trial statistician using a code with block permutation. The participant will remain free to withdraw at any time from the trial without giving reasons and without prejudicing her further treatment. Biological samples, including blood, saliva, urine, stool, vaginal swab, and intestinal luminal contents through CapScan. CapScan is a non-invasive device (capsule) that collects gastrointestinal samples along the gastrointestinal tract following ingestion and passes into the stool.\n\nOutcome measures\u002Fvariables: The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to the 35th day, +2 from the first dose of oral vancomycin.\n\nThe 11 enteropathogen targets will be detected by customized real-time quantitative PCR-based TaqMan Array Cards (TAC-qPCR) and include the following organisms: Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli (E. coli), Enteropathogenic E. coli, Enterotoxigenic E. coli, Plesiomonas, Shigella\\_Enteroinvasive E. coli (EIEC), Salmonella, and Klebsiella pneumoniae",[27,53],"Stunting",[55,56,57,58,59,60,61,62,63,64],"probiotic","microbiome","pregnant women","capscan device","urine LR","VE818","Pakistan","malnourished children","biomarkers","EED","2025-09-26",{"date":67,"type":32},"2025-10-06",{"date":69,"type":32},"2025-08-30",{"date":71,"type":21},"2026-12-31",{"name":73,"class":39},"Aga Khan University",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":40},"100505513","the-maternal-eed-study-100505513","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,"35 Years",{"count":84,"type":21},180,[86],"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.",[27,89,90,91,92],"Malnutrition","Women of Reproductive Age","Gut Microbiota","Balanced Energy Protein (BEP)",[94,95,96,89,97],"Balanced energy protein (BEP)","Environmental enteric dysfunction (EED)","Gut microbiota","Women of reproductive age","2025-05-12",{"date":100,"type":32},"2025-05-14",{"date":102,"type":32},"2023-01-02",{"date":71,"type":21},{"name":105,"class":39},"International Centre for Diarrhoeal Disease Research, Bangladesh"]