[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583306":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":12,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":12,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Meyer Children's Hospital IRCCS","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","NO_INTERVENTION","In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with standard of care therapy and free diet",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention arm","EXPERIMENTAL","In this arm patients of newly diagnosis, or who failed synthetic or biologic therapy will be treated with the Crohn Disease Exclusion Diet (CDED) plus partial enteral nutrition",[18],"Dietary Supplement: complete, polymeric formula, fiber, lactose and gluten free",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIETARY_SUPPLEMENT","complete, polymeric formula, fiber, lactose and gluten free","The dietary intervention attempts to induce remission in the first 4-week treatment without any change in the pharmaceutical therapy. In case of worsening or not reaching the outcomes, the patient will be defined as a failure and start rescue therapy with the standard of care.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Polo Lionetti, MD, PhD, Ordinary Professor","CONTACT","+39 3398416059","paolo.lionetti@unifi.it",[32],{"facility":33,"status":34,"city":35,"state":12,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"AOU Meyer IRCCS","RECRUITING","Florence","50139","Italy","IT",{"type":40,"coordinates":41},"Point",[42,43],11.24626,43.77925,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":29,"phoneExt":12,"email":30},"Paolo Lionetti, MD, PhD, Ordinary Professor",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Paolo Lionetti","Principal Investigator","100583306","evaluation-of-the-efficacy-and-tolerability-of-an-exclusion-diet-in-patients-with-juvenile-idiopathic-arthritis-100583306",false,"NCT06874608","Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis","Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis: Interventional, Exploratory Single-center, Randomized, Controlled, Open-label, add-on Study","JIA-ED","Inclusion Criteria:\n\n* Confirmed diagnosis of juvenile idiopathic arthritis (JIA) in the forms of enthesitis-related arthritis and oligoarticular forms according to the ILAR 2001 criteria (https:\u002F\u002Fmedicalcriteria.com\u002Fweb\u002Freujia\u002F);\n* Age between 6 and 18 years (not yet 18);\n* Active disease of mild to moderate severity, assessed through the Juvenile - Arthritis Disease Activity Score (JADAS10) tool (Trincianti C. et al., American College Rheumatology, 2021);\n* For study groups 2 and 3: failure of ongoing pharmacological therapy at the time of screening, defined as a failure to achieve at least a 20% reduction in JADAS10 values after 3 months of initiating DMARD therapy or biologic medication, or if the disease is inactive on such therapy, a 20% increase in those values;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients requiring systemic immunosuppressive therapy for active uveitis;\n* Patients undergoing therapy with systemic corticosteroids (defined as prednisone equivalent \\>0.5 mg\u002Fkg for \\>7 days) or intra-articular corticosteroids in the 3 months prior to enrollment;\n* Patients with fecal calprotectin values \\> 250 mcg\u002Fg at the time of screening;\n* Use of antibiotics in the month prior to enrollment.","ALL","6 Years","18 Years",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[68],"NA","The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.",[71],"Juvenile Idiopathic Arthritis (JIA)",[73,74,75],"JIA","CDED","Dietary therapy","2025-03-12",{"date":78,"type":79},"2025-03-13","ACTUAL",{"date":81,"type":79},"2024-12-12",{"date":83,"type":65},"2025-11-15",{"name":5,"class":6},1]