[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656632":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":11,"studyPopulation":11,"armGroups":27,"interventions":32,"overallOfficials":11,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":11,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Successful generation of stable and expandable human duodenal organoids from duodenal tissue",null,"Through study completion, an average of 18 months",[14,16,18],{"measure":15,"description":11,"timeFrame":12},"Determination of modifications in pathogen morphology, development, motility and viability induced by the maintenance in the model",{"measure":17,"description":11,"timeFrame":12},"Determination of functional changes and gene expression modulation induced in human the human epithelial compartment following co-culture with the enteric pathogens",{"measure":19,"description":11,"timeFrame":12},"Determination of functional changes and gene expression modulation induced in the human epithelial compartment following exposure to pathogen derivatives",{"allocation":21,"interventionModel":22,"interventionModelDescription":23,"primaryPurpose":24,"observationalModel":11,"timePerspective":11,"maskingInfo":25},"NA","SINGLE_GROUP","Patients subjected to surgical removal of a portion of the duodenum for clinical indications will donate residual biological samples for the development of duodenal organoids.","BASIC_SCIENCE",{"masking":26,"maskingDescription":11,"whoMasked":11},"NONE",[28],{"label":29,"type":6,"description":11,"interventionNames":30},"Patients subjected to surgical removal of a portion of the duodenum for clinical indications",[31],"Other: Donation of residual biological samples for the development of duodenal organoids.",[33],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Donation of residual biological samples for the development of duodenal organoids.","Donation of residual biological samples for the development of duodenal organoids that will be tested for the study of host-intestinal pathogen interactions",[29],[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Elvia Malo, Dr.","CONTACT","+39 0456014854","ricerca.clinica@sacrocuore.it",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"IRCCS Ospedale Sacro Cuore Don Calabria","RECRUITING","Negrar","Verona","37024","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],10.93899,45.52918,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":11,"email":62},"Michela Deiana, Dr.","+39 0456013311","michela.deiana@sacrocuore.it",{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[66],{"name":67,"class":6},"Universita di Verona","100656632","development-of-a-duodenal-organoid-model-for-host-intestinal-pathogen-interaction-studies-100656632",false,"NCT07828665","Development of a Duodenal Organoid Model for Host-Intestinal Pathogen Interaction Studies","Development of an in Vitro Model Based on Human Duodenal Organoids for the Study of Host-Intestinal Pathogen Interactions","DuoDenOrg","Inclusion Criteria:\n\n* Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue;\n* Availability of written informed consent for the use of biological samples for research purposes.\n\nExclusion Criteria:\n\n* Absence of informed written consent\n* Inadequate amount of histologically normal duodenal tissue","ALL","18 Years",{"count":79,"type":80},6,"ESTIMATED","INTERVENTIONAL",[21],"The goal of this clinical trial is to develop an in vitro model based on human duodenal organoids for the study of interactions between the human intestinal epithelium and enteric pathogens. Patients subjected to surgical removal of a portion of the duodenum for clinical indications, with availability of histologically normal duodenal tissue, will be asked to donate residual biological material for research purposes. The model generation procedure includes isolating intestinal stem cells from duodenal tissue, generating 3D intestinal organoids, expanding and differentiating the organoids, and inducing epithelial polarisation and maturation through air-liquid interface culture. Fully differentiated organoids will be used in in vitro co-culture experiments to assess pathogen viability, as well as the development of host epithelial responses to pathogens or their derivatives. Transcriptomic and proteomic data will also be obtained.",[85,86],"Organoid","Model Disease",[85,88,89],"In vitro model","pathogen interactions","2026-09-15",{"date":92,"type":93},"2026-09-18","ACTUAL",{"date":95,"type":93},"2026-06-09",{"date":97,"type":80},"2027-12",{"name":5,"class":6},1]