[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100420764":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Donor FMT","EXPERIMENTAL","Patients enrolled in this arm will receive donor FMT",[13],"Biological: Donor FMT",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo FMT","PLACEBO_COMPARATOR","Patients enrolled in this arm will receive placebo FMT (that will be made of water)",[19],"Other: Placebo FMT",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","This intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT",[15],[30],{"name":31,"affiliation":32,"role":33},"Gianluca Ianiro","Fondazione Policlinico Gemelli IRCCS","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","3381929859","gianluca.ianiro@hotmail.it",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Serena Porcari","porcariserena89@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS","RECRUITING","Rome","00168","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],12.51133,41.89193,{"lat":54,"lon":53},[57,60],{"name":58,"role":36,"phone":59,"phoneExt":25,"email":38},"Gianluca Ianiro, MD","0630156265",{"name":61,"role":36,"phone":25,"phoneExt":25,"email":41},"Serena Porcari, MD",{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"IANIRO GIANLUCA","Principal Investigator","100420764","phase-1-fmt-for-the-decolonization-of-carbapenem-resistant-enterobacteriaceae-100420764",false,"NCT04759001","FMT for the Decolonization of Carbapenem-resistant Enterobacteriaceae","Faecal Microbiota Transplantation to Eradicate Gut Colonisation From Carbapenem-resistant Enterobacteriaceae: a Randomised Controlled Trial","FMT-CRE","Inclusion criteria\n\n* 18 years old or older\n* Current evidence of gut colonisation (diagnosed with rectal swab) by CRE\n* Ability to give their consent to be included in the study.\n\nExclusion criteria\n\n* Another known gastrointestinal infection apart from C. difficile infection\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)\n* Previous colorectal surgery or cutaneous stoma\n* Food allergies\n* Current or recent (\\\u003C2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin)\n* Decompensated heart failure or heart disease with ejection fraction lower than 30%\n* Severe respiratory insufficiency\n* Psychiatric disorders\n* Pregnancy\n* Unable to give informed consent","ALL","18 Years","90 Years",{"count":77,"type":78},52,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","Rates of antimicrobial resistance are increasing worldwide. There is increasing evidence that physiological gut microbiota is a large reservoir of antibiotic-resistance genes. Healthy gut microbiota is known to prevent the colonization of the gastrointestinal tract by pathogens, the so-called mechanism of colonization resistance, but this protective mechanism can be altered by therapies that impair gut microbiota, including antibiotics or chemotherapeutics, with consequent colonisation of gut pathogens, including multi-drug resistant bacteria (MDRB). MDRB carriers represent an epidemiological threat to other hospitalized patients and to the whole community, but are also at risk of developing clinical consequences of this colonization, including bloodstream infections from these pathogens. Fecal microbiota transplantation (FMT) has shown high efficacy in the eradication of recurrent C. difficile infection, and initial evidence suggests that this procedure could be useful in eradicating also MDRB, mainly carbapenem-resistant Enterobacteriaceae.\n\nHowever, current evidence is mostly limited to case reports and case series, and to a single randomised trial, which was stopped early and did not draw clear conclusion. In a systematic review of 21 studies and 192 patients, eradication rates ranged from 0% to 100%, and authors concluded that larger, well designed randomised controlled trials are needed to further explore this therapy.\n\nThe aim of this study is to investigate the efficacy of FMT, compared with placebo FMT, in eradicating gut colonisation from MDRB, focusing on CRE. The investigators will randomize patients colonized by CRE (diagnosed by rectal swab) to FMT from healthy donors or placebo, by colonoscopy. Then, patients will be followed up, rectal swabs will be repeated, and stool samples for culture and microbiome analysis will be collected, up to 3 months after FMT.",[85,86],"Enterobacteriaceae Infections","Multi-antibiotic Resistance",[88,89,90],"Fecal microbiota transplantation","Enterobacteriaceae","Multi-drug resistant bacteria","2026-03-17",{"date":93,"type":94},"2026-03-19","ACTUAL",{"date":96,"type":94},"2021-02-18",{"date":98,"type":78},"2026-08-15",{"name":5,"class":6},1]