[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546702":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":45,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":40,"enrollmentInfo":73,"targetDuration":40,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":83,"whyStopped":40,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Virome Transplantation","EXPERIMENTAL","Treatment with Fecal Virome Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)",[13],"Other: Fecal Virome Transplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Fecal Microbiota Transplantation","ACTIVE_COMPARATOR","Treatment with Fecal Microbiota Transplantation capsules (one treatment) following standard treatment of antiobiotics (Vancomycin)",[19],"Other: Fecal microbiota Transplantation",[21,26],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"The primary steps of the production of fecal virome transplantation capsules is the same as when producing fecal microbiota transplantation capsules. Through an subsequent proces of filtering bacterial parts of the material are removed. The material, now called fecal virome transplanation material, has then been moved to capsules and stored in -80c untill use.",[9],[25],"Sterile fecal filtrate",{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Fecal microbiota Transplantation","Donor fecal material is mixed with cryoprotectant and NaCl. Following processing the material transfered to capsules and is stored at -80c prior to use.",[15],[31],"FMT",[33],{"name":34,"affiliation":5,"role":35},"Frederik Cold, MD, PhD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","21157167",null,"frederik.cold@regionh.dk",{"name":43,"role":38,"phone":40,"phoneExt":40,"email":44},"Morten Helms, MD, PhD","morten.helms@regionh.dk",[46],{"facility":47,"status":40,"city":48,"state":40,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":40},"Copenhagen University Hospital Hvidovre","Hvidovre","2650","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.47708,55.64297,{"lat":56,"lon":55},{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Frederik Cold","MD, PhD",[62],{"name":63,"class":6},"University of Copenhagen","100546702","virus-as-treatment-of-c-difficile-infection-vision-100546702",false,"NCT06398379","Virus as Treatment of C. Difficile Infection (VISION)","VISION","Inclusion Criteria:\n\n* Recurrent C. difficile infection (first or second recurrence)\n* Understand danish\n\nExclusion Criteria:\n\n* Serious food allergy (anaphylaxis)\n* Other pathogenic bacteria\u002Fvirus in stool sample prior to inclusion\n* Inability to ingest capsules\n* Gastrointestinal perforation in the 180 days prior to inclusion\n* Previous treatment with FMT og rectal bacteriotherapy in the 180 days prior to inclusion\n* Short bowel syndrome\n* Pregnancy or planning of pregnancy\n* Participation in other clinical trial in the 30 days prior to inclusion\n* Stoma\n* Other condition where FMT is considered contraindicated","ALL","18 Years",{"count":74,"type":75},40,"ESTIMATED","INTERVENTIONAL",[78],"NA","Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection.\n\nIn the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)",[81],"Clostridium Difficile Infections",[9,15],"NOT_YET_RECRUITING","2024-04-30",{"date":86,"type":87},"2024-05-03","ACTUAL",{"date":89,"type":75},"2024-05-01",{"date":91,"type":75},"2026-12-31",{"name":5,"class":6},1]