[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fecal-microbiota-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fecal-microbiota-transplantation":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,45,71,100,123,149,170,197,222,246,269,295,326,355,380,407,432,452,471],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100644582","fmt-for-90-day-outcome-of-clinical-use-in-icu-sepsis-100644582",false,"NCT07670299","FMT for 90-Day Outcome of Clinical Use in ICU Sepsis","Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial","FOCUS","Inclusion Criteria:\n\n* Age ≥ 18 years, any ethnicity, any gender.\n* Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.\n* Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.\n* Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.\n* Planned or recent abdominal surgery (within 14 days).\n* Current diagnosis of fulminant colitis or toxic megacolon.\n* Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg\u002Fday of prednisone or equivalent) for more than 4 consecutive weeks.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.\n* Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.","ALL","18 Years","70 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a \"functional pulse\" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.\n\nThis is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.",[28,29,30,31,32],"Sepsis","Critical Illness","Gastrointestinal Dysfunction","Dysbiosis","Fecal Microbiota Transplantation","NOT_YET_RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":22},"2026-07-15",{"date":41,"type":22},"2028-10-15",{"name":43,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100514663","fecal-microbiota-transplantation-for-decolonization-of-carbapenem-resistant-enterobacteriaceae-100514663","NCT05981430","Fecal Microbiota Transplantation for Decolonization of Carbapenem-resistant Enterobacteriaceae","Oral Fecal Microbiota Transplant Capsules for Decolonization of Carbapenem-resistant Enterobacteriaceae: a Double-blind Randomized Controlled Trial","FMT","Inclusion Criteria:\n\n* All adult patients aged 18 or above admitted to the medical ward of Queen Mary Hospital, the teaching hospital of the University of Hong Kong\n* Rectal swabs or stool specimens showing the presence of CRE\n* Positive CRE specimen within one week of commencement\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe immunodeficiency (e.g. advanced human immunodeficiency virus infection (CD4 lymphocyte count ≤200\u002Fmm3), myelosuppressive chemotherapy)\n* Significant neutropenia (absolute neutrophil count ≤1.0 x 109\u002FL)\n* Recent antibiotic use within 30 days prior to consent\n* Contraindications for capsule ingestion (dysphagia or gastrointestinal dysmotility).","90 Years",{"count":55,"type":22},80,[25],"The emergence of multidrug-resistant organisms (MDROs) has become one of the major threats to the healthcare system in Hong Kong in recent years. The situation is particularly worrisome for carbapenem-resistant Enterobacteriaceae (CRE). Taking Queen Mary Hospital as an example, the number of CRE cases has surged from 24 in year 2014 to 625 in year 2021. The case burden in Hong Kong is therefore substantial when all 43 public hospitals and institutions in Hong Kong are considered. With the widespread use of broad-spectrum antibiotics and active case screening, the number of CRE cases is expected to further increase in an exponential manner.\n\nGiven that colonization with MDROs is due to gut dysbiosis from antibiotic use, a normal intestinal microbiota is apparently crucial in protecting hosts from colonization with MDROs including CRE. Fecal microbiota transplantation (FMT), which involves the infusion of stool from a healthy donor to the gastrointestinal (GI) tract of a recipient, has gained popularity in recent years to restore colonic microbial diversity in various diseases associated with gut dysbiosis, e.g. Clostridium difficile (CD) infection, ulcerative colitis and even metabolic diseases. The investigators aim to conduct a double-blind randomized controlled trial to evaluate the benefit of FMT via upper GI delivery (oral capsules) on CRE clearance.",[59,32],"Carbapenem-Resistant Enterobacteriaceae Infection",[51,61],"CRE","2026-05-08",{"date":64,"type":37},"2026-05-13",{"date":66,"type":22},"2026-11-01",{"date":68,"type":22},"2028-06-30",{"name":70,"class":44},"The University of Hong Kong",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":79,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100537832","health-outcomes-in-c-section-infants-with-fecal-microbiota-transplantation-100537832","NCT06282952","Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation","Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)","SISU-FMT","Inclusion Criteria:\n\n* Pregnant women age 18-49 years who are scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.\n\nExclusion Criteria:\n\n* Use of regular immunosuppressive biological medication; inflammatory bowel disease in the mother; immunodeficiency disorder of the mother or any first-degree family member of the unborn baby; known or suspected major fetal congenital abnormality; travel outside Europe, the United States, Canada, Japan, Australia, or New Zealand within the last three months; and antibiotic treatment within three months of delivery (excluding prophylactic cefuroxime - or an alternative in case of allergy - administered prior to the elective cesarean section).\n* Infant exclusion criteria are preterm birth (birth before 37 weeks of gestation), birth weight below 2500 g, admission to neonatal intensive care unit, need for respiratory support or antibiotic treatment of the newborn before discharge. In case of a suspected infection or newborn screening result for severe combined immunodeficiency (SCID) is out of the normal range, of the newborn the randomization code can be opened.","FEMALE","49 Years",{"count":82,"type":22},534,[25],"The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:\n\n* Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity.\n* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.",[32,86,87],"Cesarean Section","Overweight and Obesity",[32,86,87],"RECRUITING","2026-04-01",{"date":92,"type":37},"2026-04-07",{"date":94,"type":37},"2026-03-31",{"date":96,"type":22},"2036-12-31",{"name":98,"class":44},"Oulu University Hospital",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100630347","early-phase-1-using-healthy-gut-bacteria-to-boost-immune-treatment-for-advanced-bowel-cancer-100630347","NCT07486492","Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer","An Exploratory Study of Fecal Microbiota Transplantation (FMT) Combined With Immunotherapy and Chemotherapy in Microsatellite Stable Metastatic Colorectal Cancer (MSS mCRC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of MSS mCRC\n* Experienced disease progression after first-line chemotherapy and targeted therapy\n* ECOG performance status of 0-1\n\nExclusion Criteria:\n\n* History of FMT\n* Severe organ dysfunction (heart, lung, liver, kidney)\n* Other malignancies, psychiatric disorders, pregnancy or lactation\n* Unable to provide informed consent","75 Years",{"count":109,"type":22},10,[111],"EARLY_PHASE1","This research protocol outlines an exploratory study on the combination of early-life fecal microbiota transplantation (yFMT) with immunotherapy and chemotherapy in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The single-center, single-arm study aims to assess the safety of yFMT in conjunction with immunotherapy and chemotherapy, with a secondary focus on exploring its efficacy and impact on the patients' immune microenvironment. The study will enroll 10 patients aged 18-75 who have progressed after first-line chemotherapy and targeted therapy. The intervention involves six sessions of yFMT every two weeks, alongside PD-1 inhibitor immunotherapy and FOLFIRI chemotherapy. The primary endpoints are the incidence of serious adverse events (SAEs), treatment-related adverse events (TRAEs), and intervention adjustments due to adverse events, while secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). The study is expected to last two years from initiation to data analysis completion, and it will be conducted at the Gastrointestinal Tumor Surgery Department of the First Affiliated Hospital of Xiamen University.",[114,32],"Colorectal Cancer Metastatic","2026-03-17",{"date":117,"type":37},"2026-03-20",{"date":94,"type":22},{"date":120,"type":22},"2028-01-31",{"name":122,"class":44},"The First Affiliated Hospital of Xiamen University",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":99},"100627882","phase-1-evaluation-of-the-outcome-of-fecal-microbiota-transplantation-100627882","NCT07454408","Evaluation of the Outcome of Fecal Microbiota Transplantation","A Clinical Randomized Controlled Study on the Prevention and Treatment of Drug-refractory Hepatic Encephalopathy After TIPS With Fecal Microbiota Transplantation","Inclusion Criteria:\n\n* Aged between 18 and 75 years old\n* Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery\n* Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention)\n* Provided written informed consent from the patient\n\nExclusion Criteria:\n\n* Malignant tumors of the liver, gastrointestinal tract or other systems\n* Uncontrolled severe active infection (\\>grade 2) or sepsis\n* Spontaneous bacterial peritonitis\n* Complicated with severe cardiac, renal or pulmonary insufficiency\n* Other neuropsychiatric diseases, including dementia\n* Budd-Chiari syndrome\n* Alcohol dependence or use of psychotropic drugs (benzodiazepines, opioids, etc.)\n* History of gastrointestinal surgery (e.g., colectomy) within 3 months before enrollment\n* Pregnant or lactating subjects\n* Poor compliance judged by the investigator\n* Model for End-Stage Liver Disease (MELD) score \\>17\n* Tumor, immunodeficiency, or receiving immunosuppressive therapy within 3 months before enrollment\n* Patients who have used other prebiotics, probiotics or fecal microbiota transplantation (FMT) before enrollment",true,{"count":132,"type":22},40,[134,135],"PHASE1","PHASE2","This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.",[138,32,139],"Hepatic Encephalopathy","TIPS",[138,32,139,51],"2026-03-05",{"date":143,"type":37},"2026-03-06",{"date":145,"type":22},"2026-03-07",{"date":68,"type":22},{"name":148,"class":44},"Air Force Military Medical University, China",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":99},"100622682","the-efficacy-and-safety-of-microbiota-transplantation-combined-with-prebiotics-for-treatment-of-functional-constipation-100622682","NCT07386795","The Efficacy and Safety of Microbiota Transplantation Combined With Prebiotics for Treatment of Functional Constipation","Inclusion Criteria:\n\n* Diagnosed with functional constipation (FC) according to Rome IV criteria.\n* Symptoms persisting for at least 6 months, with criteria met for the last 3 months.\n* Ineffective response to traditional treatments (dietary intervention, at least 2 types of laxatives, or probiotics).\n* Willing to discontinue other constipation medications, herbal medicines, or supplements during the study.\n\nExclusion Criteria:\n\n* History or clinical evidence of mechanical bowel obstruction (e.g., tumor or hernia).\n* Diagnosis of megarectum, megacolon, or pseudo-obstruction.\n* Organic intestinal abnormalities (obstruction, stenosis, cancer) or inflammatory bowel disease (IBD).\n* Progressive colorectal polyps requiring treatment.\n* History of gastrointestinal or abdominal surgery within the past 3 months.\n* Severe cardiovascular or cerebrovascular diseases.\n* Clinically significant liver function abnormalities (ALT\u002FAST \\> 2x ULN, TBIL ≥ 1.5x ULN).\n* Pregnancy, lactation, or planning to conceive during the study.\n* Inability to undergo colonoscopy or catheter placement.\n* Participation in other clinical trials within the past 3 months.\n* Other health conditions deemed unsuitable by the investigator.",{"count":5,"type":22},[25],"Chronic constipation is a common gastrointestinal disorder with a global prevalence of approximately 15%, severely impacting daily life and quality of life. It also increases the mortality rate from hypertension, cardiovascular diseases, and ischemic stroke, and is closely related to the incidence of colorectal cancer, making it a major chronic disease that seriously threatens people's health and quality of life. With the increasing aging population and lifestyle factors such as sedentary behavior and low-fiber diets, the incidence of functional constipation is gradually rising. Traditional treatment of chronic constipation mainly relies on various types of laxatives, which have significant side effects with long-term use and relatively high treatment costs, while surgical treatment has limited patient acceptance. Gut microbiota is closely related to intestinal motility, and patients with chronic constipation often have gut microbiota dysbiosis, with significant differences in gut microbiota diversity and colonic mucosal microbiota structure compared to healthy individuals. In recent years, more and more studies have found that intestinal microbiota-based therapies such as probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT) can effectively prevent and treat chronic constipation. FMT, as a method to reshape the gut microbiota, has been widely used in many centers at home and abroad, for diseases including inflammatory bowel disease, irritable bowel syndrome, autism, and obesity. The overall adverse reaction rate in clinical applications is approximately 3%, mainly consisting of abdominal discomfort (bloating, abdominal pain), diarrhea, and secondary intestinal infections or even bacteremia (rare). Our center has established a fecal microbiota transplantation center at Beijing Sixth Hospital within our medical alliance. We have currently performed nearly 100 cases of FMT for the treatment of IBD, autism, functional bowel diseases, and other metabolic diseases, with a clinical efficacy rate of 64-85% for functional constipation and constipation-predominant irritable bowel syndrome. This project aims to validate an intervention strategy combining fecal microbiota transplantation (FMT) with prebiotics primarily composed of high dietary fiber, based on the theoretical framework developed by the team led by Diwei Zheng at the Institute of Process Engineering, Chinese Academy of Sciences.The team found that the core microbiota playing a major role in the FMT process determines the therapeutic efficacy of FMT on diseases.These core microbial communities can produce acetic acid and butyric acid, which are important metabolites that not only reduce inflammatory levels and improve intestinal barrier function, but also provide energy for intestinal epithelial cells. Additionally, they effectively limit the growth of opportunistic pathogens by acidifying the intestinal environment, exerting antibacterial effects, and utilizing niche effects.Therefore, when the core microbiota occupies a dominant ecological niche in the gut, the gut microbiota can support health from multiple aspects including nutrition, immunity, metabolism, and psychology. Prebiotics designed based on the characteristics of the core microbiota can significantly enhance the activity and colonization of the core microbiota.This study aims to reconstruct a healthy intestinal ecosystem through FMT and prebiotics. Simultaneously, it proposes a \"co-localization\" strategy, which involves physically mixing prebiotics with core microbiota during transplantation to coexist synergistically. This approach enhances the metabolic function of core microbiota more efficiently locally, promotes the production of key metabolites such as acetic acid and butyric acid, and improves the intestinal microenvironment.Compared with the traditional stepwise model of 'microbiota transplantation + prebiotic intervention', this approach can significantly reduce the dosage of prebiotics, thereby further enhancing the safety and tolerability of the intervention.This clinical study is designed as an open-label, single-arm trial, aiming to enroll 19 patients with refractory functional constipation to receive \"core microbiota transplantation based on co-localization\".The study will focus on evaluating the therapeutic efficacy of the treatment in improving constipation symptoms, systematically assessing its safety, and comprehensively evaluating the level of gut microbiota remodeling through microbiome and metabolome approaches.The implementation of this project will provide clinical evidence for exploring the application of core microbiota therapy in functional bowel disorders such as constipation, and lay the foundation for optimizing and promoting microecological intervention strategies.",[159,160,32],"Constipation - Functional","Chronic Constipation","2026-01-27",{"date":163,"type":37},"2026-02-04",{"date":165,"type":22},"2026-02-01",{"date":167,"type":22},"2026-12-31",{"name":169,"class":44},"Peking Union Medical College Hospital",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":51,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":176,"targetDuration":178,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100310782","fecal-microbiota-transplant-national-registry-100310782","NCT03325855","Fecal Microbiota Transplant National Registry","Inclusion Criteria:\n\n* Recipient Inclusion Criteria\n\n  * Ability to give informed consent\n  * Receiving FMT or other gut-related microbiota product within 90 days after providing consent\n  * Access to internet and\u002For telephone\n* Donor Inclusion\n\n  * Ability to give informed consent\n  * Providing stool sample for FMT\n\nExclusion Criteria:\n\n* Incarceration",{"count":177,"type":22},4000,"10 Years","OBSERVATIONAL","A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness",[32,182,183],"Clostridium Difficile Infection","Gut Microbiome",[51,185,186],"CDI","Fecal Matter Transplant","2026-01-18",{"date":189,"type":37},"2026-01-21",{"date":191,"type":37},"2017-09-20",{"date":193,"type":22},"2027-08",{"name":195,"class":44},"American Gastroenterological Association",53,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100441973","phase-3-fecal-transplantation-to-eradicate-colonizing-emergent-superbugs-100441973","NCT05035342","Fecal Transplantation to Eradicate Colonizing Emergent Superbugs","FECES","Inclusion Criteria:\n\nInclusion Criteria for patients:\n\n* ≥ 18 years and \\\u003C 105 years\n* Patient with at least one positive rectal swab for enterobacteria:\n\nextended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) or carbapenem-resistant Enterobacteriaceae (CRE), or who have had an ESBL-E or CRE infection within the year For ESBL-E carriers: an ESBL-E infection within the year is mandatory\n\n\\- Patient able to take 50 capsules orally in a day and without swallowing disorders\n\nInclusion Criteria for healthy volunteers donors:\n\n* Healthy subjects ≥ 18 years and \\\u003C 50 years\n* Body mass index \\\u003C 30 kg\u002Fm\\^2\n* Regular bowel movement defined as at least 1 stool every 2 daysand maximum than 3 stools per day\n\nExclusion Criteria:\n\nExclusion Criteria for patients:\n\n* Current antibiotic treatment with te exception of long term antibiotic prophylaxis (duration of at least 3 months\u002Fyear)\n* Patients hospitalized in the intensive care unit\n* Pregnancy or breastfeeding during the study\n* Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \\[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\\] to avoid pregnancy for the entire study\n* Patient under legal protection\n* Participation in another interventional study\n* Non-affiliation to a social security scheme\n* Patient under AME\n* Refusal to participate to the study\n\nExclusion Criteria for healthy volunteers donors:\n\n* Any history of or current proctologic disease or any acute condition, which in the investigator's judgment could harm the volunteer and\u002For compromise or limit the evaluation of the protocol or data analysis (for details, please see protocol)\n* Subject under legal protection\n* Participation in any other interventional study\n* No-affiliation to a social security scheme\n* Subject under AME\n* Refusal to participate to the study\n\nRandomization criteria:\n\n* Patient colonized with a carbapenem-resistant Enterobacteriaceae (CRE) and\u002For colonized with an extended spectrum β-lactamase producing Enterobacteriaceae (ESBL-E) at inclusion on stool culture\n* Patient with an ESBL-E infection in the previous 12 months (only for participants no colonized with CRE).\n* Compatible transplant (FMT) based on patient's serological profile (CMV\u002FEBV) available","105 Years",{"count":206,"type":22},214,[208],"PHASE3","Carriage of multi-drug and extensive-drug resistant Gram negative bacteria (MDR-GNB) is associated with an increased risk of infections by these bacteria for the carriers and a high risk of dissemination both in the healthcare setting and the community; the main MDR-GNB reservoir is the fecal microbiota. To prevent both infections and dissemination, effective measures to decolonize subjects carrying MDR-GNB are urgently needed. Animal models, case reports and cohort studies suggest fecal microbiota transplantation (FMT) may be efficient for MDR-GNB decolonization.",[211,32],"Enterobacteriaceae Infections","2025-05-21",{"date":214,"type":37},"2025-05-25",{"date":216,"type":37},"2024-01-11",{"date":218,"type":22},"2028-04",{"name":220,"class":44},"Assistance Publique - Hôpitaux de Paris",11,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":244,"locationsCount":99},"100436990","phase-1-microbial-restoration-in-inflammatory-bowel-diseases-100436990","NCT04970446","Microbial Restoration in Inflammatory Bowel Diseases","The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases","MIRO II","Inclusion Criteria:\n\nActive Crohn's disease\n\n* Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND\n* CDAI score of 220-450 AND\n* One of the following:\n\n  * CRP ≥5mg\u002FL\n  * faecal calprotectin ≥100μg\u002Fg\n  * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)\n* Willing and able to attend the study sites for regular endoscopic procedures.\n\nExclusion Criteria:\n\nActive perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109\u002FL; Albumin less than 20g\u002FL; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis\u002Fsevere allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \\>20mg or budesonide dose \\>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.",{"count":231,"type":22},120,[134,135],"This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.",[32,235,236,237],"Crohn Disease","Inflammatory Bowel Diseases","Microbiome","2025-02-23",{"date":240,"type":37},"2025-02-26",{"date":242,"type":37},"2022-05-01",{"date":90,"type":22},{"name":245,"class":44},"St Vincent's Hospital Melbourne",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":130,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":99},"100576252","fecal-microbiota-transplantation-for-the-prevention-of-infectious-complications-after-liver-transplantation-100576252","NCT06782880","Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation","Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation","Inclusion Criteria:\n\n* Adult (age≥18 years) patients listed for OLT for various etiologies.\n* Patient's consent to participate in the study\n\nExclusion Criteria:\n\n* Previous total colectomy\n* Pregnancy or breastfeeding\n* Patients on oral or intravenous antimicrobial agents\n* HIV positive and not well controlled on antiretroviral therapy, or CD4+ \\\u003C200\u002F mm3\n* Active SARS-CoV-2 infection\n* Neutropenia \\\u003C0.5X10\\^9\u002FL\n* Toxic megacolon\n* Contraindications to colonoscopy\n* Any conditions for which, according to the physician, FMT endangers the patient's health\n* History of hypersensitivity to macrogol contained in bowel preparations.",{"count":254,"type":22},144,[25],"The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.",[32,258,259],"Orthotopic Liver Transplantation","Multi-drug Resistant Bacteria","2025-01-14",{"date":262,"type":37},"2025-01-20",{"date":264,"type":37},"2023-05-01",{"date":266,"type":22},"2026-05-31",{"name":268,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":99},"100502342","phase-2-synbiotics-and-fecal-microbiota-transplantation-to-treat-non-alcoholic-steatohepatitis-100502342","NCT05821010","Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis","SYNCH","Inclusion Criteria:\n\n* biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis \\\u003C4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists\n* fluency in Dutch or English\n* participants should be able to understand the information and give informed consent\n\nExclusion Criteria:\n\n* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units\u002Fday for females and more than 3 international units\u002Fday for males, on average; 1 international unit contains ±14 grams of alcohol)\n* liver cirrhosis or hepatocellular carcinoma\n* hepatitis B and\u002For C\n* auto-immune hepatitis\n* Wilson's disease\n* primary sclerosing cholangitis\n* primary biliary cholangitis\n* alpha-1-antitripsine deficiency and hemochromatosis\n* history of liver transplant, current placement on a liver transplant list\n* use of pre-, pro- or synbiotics\n* use of systemic antibiotics 3 month prior to randomization\n* use of tamoxifen, methotrexate or amiodarone\n* prior or planned bariatric surgery\n* active GLP-1 receptor agonist treated diabetes mellitus\n* bleeding disorder\n* International normalized ratio (INR) of prothrombin time \\>1.4 or platelet count \\\u003C100 109\u002FL at screening\n* anti-platelet\u002Fcoagulant therapy use which cannot be temporarily discontinued\n* any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident)\n* prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count \\\u003C 240)\n* active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \\[e.g., cervix\\] or non-melanoma skin cancer) unless a complete remission was achieved\n* surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator\n* pregnant or nursing women\n* any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol\n* participation in another concomitant clinical trial.",{"count":277,"type":22},48,[135],"The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:\n\n1. Can NASH be treated by altering the gut microbiota using LFMT capsules?\n2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?\n3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH?\n\nParticipants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.",[281,282,32,51,283,284,237,285,183],"Non Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease","Prebiotics","Probiotics","Intestinal Microbiome","2024-08-26",{"date":288,"type":37},"2024-08-27",{"date":290,"type":37},"2023-03-17",{"date":292,"type":22},"2026-08-20",{"name":294,"class":44},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":99},"100499984","fecal-microbial-transplantation-for-rheumatoid-arthritis-trial-100499984","NCT05790356","Fecal Microbial Transplantation for Rheumatoid Arthritis Trial","FeMiTRA","Inclusion Criteria:\n\n* 18-years old or older\n* RA diagnosis by ACR\u002FEULAR criteria \\[26\\]\n* Positive for the RA-associated antibodies, anti-citrullinated protein\u002Fpeptide antibodies (ACPA) and\u002For rheumatoid factor (RF)\n* Stable RA therapy \\> 6 months\n* Patient in remission or low disease activity by DAS28\n* Consents to study\n\nFecal Donor Inclusion Criteria:\n\n* A healthy donor who has a normal body mass index (BMI of 18.5-30) and who satisfies the following criteria will be selected from a pool of donors available in the Infectious Diseases clinic at St. Joseph's Hospital supervised by Dr. Silverman and screened for all transmissible agents. at the Microbiology and Immunology lab at St. Joseph's Hospital under Dr. Silverman for the study and screened for transmissible agents.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Current or recent \\[in the last 60 days\\] exposure to high dose oral (\\>30 mg of prednisone daily or equivalent), IV corticosteroids, biologic therapies or JAKi.\n* Patients who require inhaled steroids or local steroid injections are not excluded from the study\n* Has a diagnosis of immunodeficiency (HIV, transplantation, or autoimmune disease other than RA requiring immunosuppressive therapies), or currently receiving systemic steroid therapy (\\>10 mg prednisone daily or equivalent)\n* Received rituximab or other chemotherapeutic agent in the last 2 years.\n* Expected to require any other form of systemic or localized anti-neoplastic therapy while on study\n* Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years. NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.\n* Ongoing use of antibiotics\u002Fanti-virals or previous use of antibiotics\u002Fanti-virals in the last 3 months prior to the FMT procedure\n* Has an active infection requiring systemic therapy or requiring hospital admission in last 3 months.\n* Presence of a chronic intestinal disease (e.g. Celiac disease, malabsorption, colonic tumor, IBD)\n* Presence of absolute contra-indications to FMT administration\n* Toxic megacolon\n* Anaphylactic allergic reactions to food (e.g. shellfish, nuts, seafood, eggs)\n* Has serious uncontrolled concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), severe obstructive or restrictive pulmonary diseases, cirrhosis or ALT\\>100, renal disease with GFR\\\u003C50 and uncontrolled psychiatric illness.\n* Patient has received a live vaccine within 4 weeks prior to the first dose of treatment\n* Insulin-dependent diabetes\n* Previous bariatric surgery\n* Chronic neutropenia (\\\u003C0.5) Currently participating in another clinical trial\n\nFecal Donor Exclusion Criteria:\n\n* Any underlying metabolic disease including; hypertension, hyperlipidemia, diabetes, insulin insensitivity, atherosclerosis\n* A history of any gastrointestinal or liver disorders or cancers. Including but not limited to; gastroesophageal reflux, peptic ulcer disease, celiac disease, inflammatory bowel disease (Crohn's disease or ulcerative colitis), microscopic colitis, motility disorders (including gastroparesis and irritable bowel syndrome) diverticular disease\n* Previous surgery to the intestine, liver or gallbladder (except remote appendectomy)\n* History of any malignancy\n* Use within 3 months of any antibiotics\n* Hospitalization within 3 months\n* Recent travel to a developing country (within 3 months).\n* New Sexual Partner (within 3 months)\n* Street drug use, family history of diabetes, early onset coronary disease or gastrointestinal or liver disease, colon cancer, familial malignancy\n* Psychiatric history (major affective disorder, psychotic illness, ongoing use of any psychiatric medications)\n* Any positive laboratory results for a transmissible pathogen\n* Alcohol intake with a cut off value of \\\u003C10g\u002Fd in women and \\\u003C20g\u002Fd in men\n* Currently participating in another clinical trial that may alter fecal composition.",{"count":303,"type":22},30,[25],"This clinical trial will investigate the effects of capsules containing stool from healthy donors, called fecal microbial transplant (FMT), in rheumatoid arthritis patients.",[307,308,32],"Arthritis","Arthritis, Rheumatoid",[307,310,311,312,313,314,315,316,317],"Rheumatoid","Rheumatoid Arthritis","clinical trial","fecal matter transplantation","fecal matter transplant","faecal","autoimmune","proof of concept","2024-08-19",{"date":320,"type":37},"2024-08-21",{"date":322,"type":37},"2023-08-01",{"date":90,"type":22},{"name":325,"class":44},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":99},"100538944","phase-2-efficacy-and-safety-of-fmt-for-the-treatment-of-ibs-d-and-mental-health-comorbidity-in-young-adults-100538944","NCT06297421","Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults","Efficacy and Safety of Fecal Microbiota Transplantation for the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults: A Randomized, Double-blind, Placebo Controlled Study","Inclusion Criteria:\n\n1. Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.\n2. Age between 18 and 29 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.\n3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was \\>25% for Bristol fecal trait type 6 or 7, and \\\u003C25% for Bristol fecal trait type 1 or 2；and a Hamilton Depression Scale score: 20-34 and\u002For a Hamilton Anxiety Scale score: 14-28 were evaluated as depressed or anxious patients;\n4. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was \\>5mm or the number of intestinal polyps was \\>3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.\n5. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.\n6. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.\n\nExclusion Criteria:\n\n1. Patients with constipated, mixed and amorphous IBS.\n2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).\n3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.\n4. Known to have lactose intolerance and celiac disease.\n5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.\n6. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section but no intestinal complications, hernia repair.\n7. Patients with severe mental disorders other than depression and anxiety.\n8. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.\n9. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.\n10. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and\u002For ALT≥2 times upper limit of normal (ULN) and\u002For total bilirubin ≥1.5 times upper limit of normal (ULN).\n11. A history of drug or alcohol abuse.\n12. Even with the help of liquids, patients are unable to take oral solid dosage forms.\n13. Allergic to experimental drugs, rescue drugs and their ingredients.\n14. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc.\n15. A woman who is pregnant or breastfeeding.\n16. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.\n17. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.\n18. The patient had previously participated in a clinical study of FMT and received FMT therapy.\n19. According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.","29 Years",{"count":335,"type":22},88,[135],"The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.",[339,32,340],"Irritable Bowel Syndrome With Diarrhea","Mental Health Issue",[342,32,343,344,345],"Irritable Bowel Syndrome with Diarrhea","Randomized Controlled Study","Mental Health Comorbidity","Young Adults","2024-07-12",{"date":348,"type":37},"2024-07-16",{"date":350,"type":22},"2024-09",{"date":352,"type":22},"2026-06",{"name":354,"class":44},"Shenzhen Hospital of Southern Medical University",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":379},"100531904","phase-2-efficacy-and-safety-of-fecal-microbiota-transplantation-fmt-in-reducing-recurrence-of-colorectal-adenoma-cra-100531904","NCT06205862","Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)","Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-75, gender not specified.\n2. Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.\n3. Individuals who are able to swallow pills\u002Fcapsules.\n4. Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks\u002Fbenefits of the study.\n\nExclusion Criteria:\n\n1. Individuals in whom the adenoma was not completely removed in a previous colonoscopy;\n2. Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;\n3. Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC\u002FLynch syndrome);\n4. Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;\n5. Individuals with a history of subtotal or total gastrectomy or partial bowel resection;\n6. People who cannot tolerate colonoscopy;\n7. Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;\n8. Individuals with serious heart, liver, or kidney diseases, or any history of cancer;\n9. People suffering from severe constipation;\n10. Pregnant women, breastfeeding mothers, or women planning to become pregnant;\n11. Patients with mental illness who are unable to cooperate;\n12. Individuals involved in the design, planning, or execution of this trial;\n13. Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.",{"count":363,"type":22},466,[135],"The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection.\n\nThe main questions it aims to answer are:\n\n* the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection.\n* changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment.\n* changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation.\n\nParticipants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).",[32,367,368],"Colorectal Adenoma","Gastrointestinal Microbiome",[32,370,368,371],"Colorectal Adenomas","Recurrence rate after endoscopic resection",{"date":373,"type":37},"2024-07-15",{"date":375,"type":37},"2024-04-09",{"date":377,"type":22},"2028-12",{"name":354,"class":44},5,{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":388,"enrollmentInfo":389,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":405,"locationsCount":4},"100552618","fecal-microbiota-transplantation-in-the-treatment-of-major-lars-100552618","NCT06475430","Fecal Microbiota Transplantation in the Treatment of Major LARS","Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome (LARS)","FMT-LARS","Inclusion Criteria:\n\n\\- Age ≥ 18 years old, regardless of gender; Patients with rectal cancer who have undergone total mesorectal excision (TME) and sphincter-preserving surgery, and the postoperative period is more than 3 months; Patients with a LARS score of 21 to 42; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Expected survival period ≥ 1 year; Voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n\\- Patients with pre-operative symptoms of fecal and urinary incontinence; Patients who have undergone pelvic surgery or LAR due to non-cancerous reasons; Patients who have undergone pelvic radiotherapy; Patients with prophylactic ostomy; Patients who have used any antibiotic medication, probiotic products, or prebiotic products in the past 4 weeks; Patients who have regularly used laxatives in the past two weeks; Pregnant or lactating women; Human immunodeficiency virus (HIV) positive; Known history of active pulmonary tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs; Untreated patients with chronic hepatitis B or HBV carriers with HBV DNA exceeding 500 IU\u002FmL, or patients with active hepatitis C should be excluded. Non-active HBsAg carriers, treated and stable hepatitis B patients (HBV DNA \\\u003C 500 IU\u002FmL), and cured hepatitis C patients can be enrolled. For subjects with positive HCV antibodies, only those with negative HCV RNA test results are eligible to participate in the study; Known history of psychiatric drug abuse, alcoholism, and drug abuse; Patients with cognitive impairment; Any situation where the investigator believes the participant should be excluded from the study.","80 Years",{"count":132,"type":22},[25],"Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.",[393,32],"Low Anterior Resection Syndrome",[395,396,397,398],"low anterior resection syndrome","bowel function","fecal microbiota transplantation","intestinal microbiota","2024-06-20",{"date":401,"type":37},"2024-06-26",{"date":403,"type":22},"2025-01-01",{"date":167,"type":22},{"name":406,"class":44},"Peking University People's Hospital",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":99},"100467056","fecal-microbiota-transplantation-for-irritable-bowel-syndrome-associated-food-intolerance-100467056","NCT05361785","Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance","FinFMT-IBS","Inclusion Criteria:\n\n* Adults, age 18-75 years, knowledge of the Finnish language\n* IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial\n* The patient must consume low FODMAP diet to control IBS symptoms\n* Patient must sign the informed consent\n\nExclusion Criteria:\n\n* Diagnosed allergies to food components in the study dietary protocol\n* Pregnancy and breastfeeding\n* Antibiotic treatment less than three months prior enrolment\n* Faecal incontinence, i.e., inability to retain enema\n* Abuse of drugs, alcohol or medications\n* Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.\n* Severe psychiatric or neurologic condition decreasing patient's compliance",{"count":415,"type":22},45,[25],"Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.\n\nThe purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.",[419,32],"Irritable Bowel Syndrome",[51,421,422],"IBS","FODMAP","2022-05-09",{"date":425,"type":37},"2022-05-13",{"date":427,"type":37},"2022-04-30",{"date":429,"type":22},"2026-07-31",{"name":431,"class":44},"Helsinki University Central Hospital",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":99},"100332842","phase-2-fecal-microbiota-transplantation-for-irritable-bowel-syndrome-100332842","NCT03613545","Fecal Microbiota Transplantation for Irritable Bowel Syndrome","Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome","Inclusion Criteria:\n\nTo be considered eligible for enrolment into the study, subjects must:\n\n* Be able to give written informed consent.\n* Males and females aged \\>18 and \\\u003C75\n* Have IBS as defined by the Rome IV criteria\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the below criteria:\n\n* pregnant or having a follow-up of less than 6 months;\n* unable to give informed consent;\n* suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;\n* unable to undergo endoscopy.",{"count":231,"type":22},[135,208],"Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his\u002Fher intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.",[419,32],"2021-08-01",{"date":445,"type":37},"2021-08-03",{"date":447,"type":37},"2018-08-10",{"date":449,"type":22},"2030-12-31",{"name":451,"class":44},"Guangzhou First People's Hospital",{"id":453,"slug":454,"hasResults":11,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":51,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":99},"100416741","efficacy-and-safety-of-fecal-microbiota-transplantation-100416741","NCT04706611","Efficacy and Safety of Fecal Microbiota Transplantation","Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Intestinal Dysbiosis -A Pilot Study","Inclusion Criteria:\n\nConfirmed diagnosis of any of following diseases:\n\n* Irritable Bowel Syndrome\n* Ulcerative colitis\n* Crohn's disease\n* Constipation\n* Clostridium Difficile Infection\n* Functional Dyspepsia\n* Parkinson's Disease\n* Metabolic Syndrome\n* Non-Alcoholic Fatty Liver Disease\n* Autism Spectrum Disorder\n* Radiation Enteritis\n* Atopic Dermatitis\n* Food Allergic\n* Graft-versus-Host Disease\n* Obesity\n* Diabetes mellitus\n* Multi-Drug Resistant Infection\n* Hepatic Encephalopathy\n* Enteric Dysbacteriosis\n* Multiple Sclerosis\n* Pseudomembranous Enteritis\n* Acute Pancreatitis\n* Chronic Fatigue Syndrome\n* Acute-on-chronic Liver Failure with HBV Infection\n* Alcoholic Liver Disease\n* Anorexia\n* Decompensated Cirrhosis\n* Henoch-Schonlein Purpura\n* Autoimmune Liver Disease\n* Systemic Lupus Erythematosus\n* Rheumatoid arthritis\n* IgG4-Related Disease\n* Celiac Disease\n* Protein-losing Enteropathy\n* Asperger Syndrome\n* Rheumatoid arthritis\n* Psoriasis\n* Ankylosing spondylitis\n* Immune checkpoint inhibition-related colitis\n* Autoimmune enteropathy\n* Drug-induced diarrhea\n* Suffering from gastrointestinal symptoms such as constipation, diarrheas, abdominal pain, flatulence, etc.\n* The participants must be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.\n\nExclusion Criteria:\n\n* Current pregnancy or breast-feeding;\n* Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;\n* Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;\n* Any conditions that may render the efficacy of FMT or at the discretion of the investigators.",{"count":460,"type":22},300,[25],"In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.",[32],"2021-04-06",{"date":466,"type":37},"2021-04-08",{"date":468,"type":37},"2021-01-15",{"date":167,"type":22},{"name":451,"class":44},{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":490,"locationsCount":99},"100347529","phase-2-fecal-microbiota-transplantation-for-ulcerative-colitis-100347529","NCT03804931","Fecal Microbiota Transplantation for Ulcerative Colitis","Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis","Inclusion Criteria:\n\n* Active, moderate to severe severity (Mayo score more than 6)\n* Safety using history of 5-ASA\n* Able to undergo endoscopy examination\n\nExclusion Criteria:\n\n* Antibiotic using in 7 days\n* High risk of toxic megacolon\n* Colon cancer or neoplasia in pathophysiology\n* Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)","65 Years",{"count":231,"type":22},[135,208],"Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his\u002Fher intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).",[483,32],"Ulcerative Colitis","2019-01-12",{"date":486,"type":37},"2019-01-15",{"date":488,"type":22},"2019-01-20",{"date":449,"type":22},{"name":451,"class":44}]