[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436990":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":47,"locations":55,"responsibleParty":73,"collaborators":76,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":75,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":28,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":28,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"St Vincent's Hospital Melbourne","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT arm","ACTIVE_COMPARATOR","Anaerobically prepared, freeze-thawed faecal microbiota transplantation",[13,14,15],"Drug: Antibiotics","Dietary Supplement: Dietician designed diet","Drug: FMT",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo arm","PLACEBO_COMPARATOR","Placebo liquid formulation (normal saline, glycerol, food colorant)",[13,14,21],"Other: Placebo",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Antibiotics","All patients will receive a one week course of antibiotic therapy.",[9,17],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DIETARY_SUPPLEMENT","Dietician designed diet","All patients will be recommended dietary modification 3 weeks prior to, and during, the study.",[9,17],{"type":24,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"FMT","Anaerobically prepared stool. Dosing will vary according to mode of administration.",[9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Placebo","Placebo will contain food colourant, 0.9% normal saline and glycerol.",[17],[43],{"name":44,"affiliation":45,"role":46},"Michael A Kamm, MD","St Vincents Hospital","PRINCIPAL_INVESTIGATOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":28,"email":52},"Amy Wilson O'Brien","CONTACT","0392311352","amy.wilson-obrien@svha.org.au",{"name":54,"role":50,"phone":28,"phoneExt":28,"email":28},"Sasha Fehily, MD",[56],{"facility":45,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":64,"coordinates":65},"Point",[66,67],144.96332,-37.814,{"lat":67,"lon":66},[70],{"name":71,"role":50,"phone":28,"phoneExt":28,"email":72},"Sasha Fehily","miro.study@svha.org.au",{"type":46,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Michael Kamm","The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases",[77,79,82,84],{"name":78,"class":6},"The Queen Elizabeth Hospital",{"name":80,"class":81},"BiomeBank Adelaide","UNKNOWN",{"name":83,"class":6},"The University of Queensland",{"name":85,"class":6},"Monash University","100436990","phase-1-microbial-restoration-in-inflammatory-bowel-diseases-100436990",false,"NCT04970446","Microbial Restoration in Inflammatory Bowel Diseases","MIRO II","Inclusion Criteria:\n\nActive Crohn's disease\n\n* Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND\n* CDAI score of 220-450 AND\n* One of the following:\n\n  * CRP ≥5mg\u002FL\n  * faecal calprotectin ≥100μg\u002Fg\n  * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)\n* Willing and able to attend the study sites for regular endoscopic procedures.\n\nExclusion Criteria:\n\nActive perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109\u002FL; Albumin less than 20g\u002FL; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis\u002Fsevere allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \\>20mg or budesonide dose \\>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.","ALL","18 Years","70 Years",{"count":97,"type":98},120,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.",[105,106,107,108],"Fecal Microbiota Transplantation","Crohn Disease","Inflammatory Bowel Diseases","Microbiome","2025-02-23",{"date":111,"type":112},"2025-02-26","ACTUAL",{"date":114,"type":112},"2022-05-01",{"date":116,"type":98},"2026-04-01",{"name":5,"class":6},1]