[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573155":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":20,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":20},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"patients diagnosed as IBD aged from 1 month to 16 years","EXPERIMENTAL","study will include 2 groups of pediatric IBD patients planned to start biological treatment or change to other biological therapy and each group formed of 20 patients Group\n\n1 of patients will receive Adalimumab while Group 1 will receive ustekinumab",[13],"Biological: Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab","All the patients will be treated according to guidelines of ECCO\u002FESPGHAN and will be followed up regularly for 12 months by assessment\n\n• response to treatment Frequency of relapses,\n\nRegular assessment will be:\n\nClinically every 2 to 4 weeks at gastroenterology outpatient clinic by using activity scoring systems:\n\npediatric Ulcerative Colitis Activity Index pediatric Chron's Disease Activity Index\n\nLaboratory follow up will done at weeks 12,24,36,48 of starting or changing to other biological by doing inflammatory markers( CBC, ESR, CRP, albumin. At the end of study(week 48) each patient will be reassessed by:\n\nDisease activity:\n\nLaboratory Endoscopy will be repeated at week 48 of starting or changing to other biological to assess effect of biologicals on reach mucosal healing.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":20},"Mohamed nageh abdelhamed, master degree in pediatrics","CONTACT","hossam26620@gmail.com","2001150181507",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100573155","early-phase-1-efficacy-of-biological-therapy-in-pediatric-inflammatory-bowel-disease-100573155",false,"NCT06742606","Efficacy of Biological Therapy in Pediatric Inflammatory Bowel Disease","Inclusion Criteria:\n\nPatients fulfilling modified Porto criteria for diagnosis of IBD including clinical features, laboratory, radiological and pathological findings.\n\nPatients initially severely diseased or in relapse and planned to start or change biological therapy.\n\nExclusion Criteria:\n\nPatients already on biological therapy and controlled. Patients with known humeral or cell mediated immunodeficiency.\n\nEthical","ALL","1 Month","16 Years",{"count":39,"type":40},40,"ESTIMATED","INTERVENTIONAL",[43],"EARLY_PHASE1","Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.",[46],"Effect of Drug",[48],"biological therapy , IBD","NOT_YET_RECRUITING","2024-12-18",{"date":52,"type":53},"2024-12-19","ACTUAL",{"date":55,"type":40},"2025-01-15",{"date":57,"type":40},"2026-12-13",{"name":5,"class":6}]