[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584972":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":44,"responsibleParty":65,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"IRCCS Ospedale San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Patients who accept participation and are randomized to receive dietary advice on the CDED diet will be included in the intervention group.",[13],"Combination Product: CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation",[19],"Drug: Anti-TNF Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy","Patients in the experimental group will receive professional dietary advice on how to adhere to CDED for 12 weeks, in addition to anti-TNF therapy while patients in the control group will receive only anti-TNF therapy for the entire duration of the study.\n\nDiet adherence is completely voluntary and is not enforced in any way. CDED is divided into 3 phases, the first two, grouped as the induction phase, with 6 weeks of strict diet and 6 weeks to gradual food reintroduction, followed by 12 weeks of patients follow-up.\n\nFive foods (chicken, eggs, potatoes, apple and bananas) are permitted at the start of the diet; the patient can then choose to consume a range of permitted foods at will, the variability of which increases after the first six weeks",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Anti-TNF Therapy","The control group will receive only anti-TNF therapy as per standard of care. This therapy is recommended by guidelines and is the cornerstone of treatment of Crohn's disease and ulcerative colitis.",[15],[33],{"name":34,"affiliation":5,"role":35},"Tommaso Lorenzo Parigi, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+39 02 2643 2756","parigi.tommaso@hsr.it",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"Annunziata Bruno, MS","bruno.annunziata@hsr.it",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Milan","Michigan","20132","Italy","IT",{"type":53,"coordinates":54},"Point",[55,56],12.59836,42.78235,{"lat":56,"lon":55},[59,60,61,62],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Mariangela Allocca, MD","SUB_INVESTIGATOR",{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tommaso Lorenzo Parigi","Gastroenterologist","100584972","impact-of-exclusion-diet-in-addition-to-anti-tnf-therapy-in-crohns-disease-and-ulcerative-colitis-a-prospective-randomized-double-arm-open-label-study-100584972",false,"NCT06896305","Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study","Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study","IDEA-TNF","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent forparticipation in the study\n2. Males or Females, Adults aged 18 years or older\n3. Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis\n4. Patients who are planned to start anti-TNF therapy\n5. Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)\n\nExclusion Criteria:\n\n1. Patients with undetermined inflammatory bowel disease\n2. Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)\n3. Patients with a body-mass index lower than 17 or greater than30\n4. Patients who previously underwent intestinal resectionirrespective of cause\n5. Patients currently on exclusive enteral nutrition (EEN)\n6. Patients who have previously used or are currently adhering toCDED\n7. Pregnant or breastfeeding women\n8. Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED\n9. Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant\n10. Inability or unwillingness to comply with study protocols orfollow-up schedules","ALL","18 Years",{"count":79,"type":80},80,"ESTIMATED","INTERVENTIONAL",[83],"NA","This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis.\n\nThe study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.\n\nOne group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED.\n\nBy prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.",[86,87],"Ulcerative Colitis (UC)","Crohn Disease (CD)",[89,90,91,92,93],"Inflammatory Bowel Disease","Anti-TNF","Crohn's Disease Exclusion Diet","Ulcerative colitis","Crohn","2026-01-20",{"date":96,"type":97},"2026-01-22","ACTUAL",{"date":99,"type":97},"2025-05-22",{"date":101,"type":80},"2027-10-01",{"name":5,"class":6},1]