[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576252":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heterologous FMT","EXPERIMENTAL","Heterologous feces will be processed from routinely screened universal donors. Adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for Fecal Microbiota Transplantation. Fecal material must be infused by enema or colonoscopy.",[13],"Procedure: Fecal microbiota transplantation (FMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Homologous FMT","PLACEBO_COMPARATOR","The control arm will undergo autologous FMT after enrollment. Autologous feces will be collected by each patient the day before each FMT in both study arms. This will guarantee adequate patients' stool collection in order to subsequently store the fecal samples for autologous FMT and ensure blinding.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Fecal microbiota transplantation (FMT)","To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Giovanni Barbara, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","+390512144103","giovanni.barbara@unibo.it",[36],{"facility":5,"status":37,"city":38,"state":25,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Bologna","40138","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],11.33875,44.49381,{"lat":46,"lon":45},[49,50],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":28,"role":29,"phone":25,"phoneExt":25,"email":25},{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100576252","fecal-microbiota-transplantation-for-the-prevention-of-infectious-complications-after-liver-transplantation-100576252",false,"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.",true,"ALL","18 Years",{"count":64,"type":65},144,"ESTIMATED","INTERVENTIONAL",[68],"NA","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.",[71,72,73],"Fecal Microbiota Transplantation","Orthotopic Liver Transplantation","Multi-drug Resistant Bacteria","2025-01-14",{"date":76,"type":77},"2025-01-20","ACTUAL",{"date":79,"type":77},"2023-05-01",{"date":81,"type":65},"2026-05-31",{"name":5,"class":6},1]