[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":30,"locations":39,"responsibleParty":59,"collaborators":18,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IFX + mCDED","EXPERIMENTAL","Participants will follow the modified Crohn's disease exclusion diet (mCDED) for 6 months, when initiating their infliximab therapy as part of their routine care",[13],"Other: IFX + mCDED",{"label":15,"type":16,"description":17,"interventionNames":18},"IFX","NO_INTERVENTION","Participants will initiate their infliximab therapy as part of their routine care",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"modified Crohn's Disease Exclusion Diet (mCDED) ; Diet intervention",[9],[24,28],{"name":25,"affiliation":26,"role":27},"Kevan Jacobson, MBBCh, FRCP, FRCPC, AGAF, CAGF","The University of British Columbia","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":26,"role":27},"Genelle Lunken, BSc, PhD, RD",[31,35],{"name":25,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","604-875-2332","kjacobson@cw.bc.ca",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Fanny Lemarie, MSc, PhD","604-441-4992","fanny.lemarie@ubc.ca",[40],{"facility":26,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Vancouver","British Columbia","V5Z 4H4","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-123.11934,49.24966,{"lat":51,"lon":50},[54,55,56],{"name":25,"role":32,"phone":33,"phoneExt":18,"email":34},{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Sally Lawrence, MBChB, MRCPCH, FRCPH","SUB_INVESTIGATOR",{"type":27,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Kevan Jacobson","Clinical Professor","100617129","combining-nutritional-therapy-and-anti-tnf-treatment-in-pediatric-patients-with-crohns-disease-100617129",false,"NCT07314606","Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease","Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy","DISPENSE-T","Inclusion Criteria:\n\n* Moderate-severe active luminal inflammatory (B1) pCD \\[wPCDAI \\> or = 40\\] ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* Within 12-months of diagnosis (when starting IFX treatment)\n* Naïve to a biologic therapy\n* For patients with established disease who flare up: no response to dietary intervention or steroids within 4 weeks of commencement of these therapies.\n* For newly diagnosed patients: no response to dietary intervention or steroids within 2 weeks of commencement of these therapies.\n* Evidence of active inflammation: FCP level \\> 250 µg\u002Fg and\u002F or CRP \\> 5 mg\u002FL or ESR \\> 20 mm\u002Fhr\n* BMI between the 5th and 95th percentiles, adjusted for age and sex\n* On steroids or EEN for less than 2 (or 4, for established disease) weeks\n* Able and willing to follow dietary recommendations\n* On stable dose of AZA or Methotrexate (MTX) at randomization\n* Willing to enroll in the CIDsCaNN Network study\n\nExclusion Criteria:\n\n* CDED, EEN, or steroids commenced more than 2 weeks prior to randomization\n* Antibiotic use in the last 2 months (except short course \\\u003C 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)\n* Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)\n* Strict vegetarians and vegans\n* High risk of malnutrition as assessed by the Paediatric Yorkhill Malnutrition Score (PYMS)\n* Other known GI disorders (except IBS), food intolerances or chronic diseases\n* Bowel surgery prior the randomization\n* Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease\n* Currently on prednisone\u002Fprednisolone for \\> 2 weeks\n* Pregnant or breastfeeding\n* Participating in another study\n* Inability to consent","ALL","9 Years","17 Years",{"count":74,"type":75},140,"ESTIMATED","INTERVENTIONAL",[78],"NA","Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.",[81,82,83],"Crohn Disease (CD)","IBD (Inflammatory Bowel Disease)","IBD - Inflammatory Bowel Disease",[85,86,87,88,89,90],"CDED","Exclusion Diet","Infliximab","Nutritional therapy","Pediatric","Diet Intervention","2026-04-27",{"date":93,"type":94},"2026-05-01","ACTUAL",{"date":96,"type":94},"2026-04-22",{"date":98,"type":75},"2029-10-01",{"name":5,"class":6},1]