[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623826":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":75,"collaborators":77,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":31,"enrollmentInfo":89,"targetDuration":31,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Alberta","OTHER",[8,14,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjunct therapy group (LFMT)","EXPERIMENTAL","Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks\n\nMaintenance phase: 1 capsule daily x 16 weeks",[13],"Other: Lyophilized Fecal Microbiota Transplantation (LFMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Adjunct therapy group (Placebo)","PLACEBO_COMPARATOR","The placebo capsules will appear identical to LFMT capsules and same dosing will apply.",[19],"Other: Placebo",{"label":21,"type":10,"description":11,"interventionNames":22},"Co-Administration therapy group (LFMT)",[13],{"label":24,"type":16,"description":17,"interventionNames":25},"Co-Administration therapy group (Plcebo)",[19],[27,32],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Lyophilized Fecal Microbiota Transplantation (LFMT)","LFMT by oral capsules",[9,21],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","Placebo capsules does not contain FMT",[15,24],[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Dina Kao, MD,FRCPC","CONTACT","780-492-5257","dkao@ualberta.ca",[43,62],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of Calgary","NOT_YET_RECRUITING","Calgary","Alberta","T2N-1N4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-114.08529,51.05011,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":31,"email":61},"Humberto Jijon, MD","403-220-3719","humberto.jijon2@ucalgary.ca",{"facility":5,"status":63,"city":64,"state":47,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"RECRUITING","Edmonton","T6G2R3",{"type":52,"coordinates":67},[68,69],-113.46871,53.55014,{"lat":69,"lon":68},[72],{"name":73,"role":39,"phone":74,"phoneExt":31,"email":41},"Dina Kao, MD, FRCPC","780-248-1342",{"type":76,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[78],{"name":44,"class":6},"100623826","phase-1-fecal-microbiota-transplantation-in-an-expanded-ulcerative-colitis-population-100623826",false,"NCT07401680","Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population","A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)","FRONTIER-UC","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Able to provide informed consent\n3. Established UC diagnosis through standard endoscopic and histologic criteria\n4. Active UC\n5. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial\n6. Willing and able to comply with all required study procedures\n\nExclusion Criteria:\n\n1. Severe UC requiring hospitalization\n2. Crohn's disease or indeterminate colitis\n3. Irritable bowel syndrome\n4. Intestinal infection within 4 weeks of enrollment\n5. Evidence of toxic megacolon or gastrointestinal perforation on imaging\n6. Planned colectomy\n7. Abdominal surgery within 60 days of enrollment\n8. Neutropenia with absolute neutrophil count \\\u003C0.5 x 109\u002FL\n9. Peripheral white blood cell count \\> 35.0 x 109\u002FL and fever (\\>38C)\n10. Planned or actively taking another investigational product\n11. Uncontrolled medical conditions such as psychiatric disorders or substance abuse\n12. Severe underlying disease such that the patient is not expected to survive for at least 30 days\n13. Pregnancy or breastfeeding\n14. Unwilling to discontinue non-dietary probiotic\n15. Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study\n16. FMT for any reason within 6 months of enrollment\n17. Investigator's judgement that enrolment is not in the best interest of the patient","ALL","18 Years",{"count":90,"type":91},85,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.",[97,98,99],"Ulcerative Colitis","Inflammatory Bowel Diseases","Clostridioides Difficile Infection",[101,102,103,104],"Fecal microbiota transplantation","FMT","Lyophilized fecal microbiota transplantation","LFMT","2026-06-02",{"date":107,"type":108},"2026-06-04","ACTUAL",{"date":110,"type":108},"2026-03-01",{"date":112,"type":91},"2028-12-01",{"name":5,"class":6},2]