[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602316":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":62,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":20,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":90,"whyStopped":20,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Cook Children's Health Care System","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Pediatric patients with clinical signs and symptoms suggestive of IBD or with established diagnosis of IBD (newly diagnosed or on therapeutic management) who are scheduled to undergo Esophagogastroduodenoscopy (EGD) and\u002For Ileocolonoscopy (IC) with CLE as part of their clinical management",[13],"Device: Confocal Laser Endomicroscopy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Confocal Laser Endomicroscopy","Patients will undergo Esophagogastroduodenoscopy (EGD) and\u002For Ileocolonoscopy (IC) EGD with CLE as per standard of care. Each participant will have 3-4 mucosal biopsies taken from the terminal ileum, rectosigmoid and cecum, ideally from the most affected areas of accessible segment.\n\nEx vivo staining of biopsied tissue will be expanded to include FITC-labeled antibodies to cytokines IL12 and IL12\u002FIL23 and to cytokine receptors IL12R and IL23R and possibly other cytokines, receptors and adhesion molecules. All biopsies tested for membrane bound antibodies will be done using CLE technology with artificial intelligence (AI). The cellular landscape will be characterized by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nWe will develop algorithm using AI to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Clifton Huang, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sumith Roy, MBBS, MPH","CONTACT","682-885-1790","Sumith.Roy@cookchildrens.org",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":20},"Chief Research Officer",[34,52],{"facility":35,"status":20,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Texas at Arlington","Arlington","Texas","76010","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-97.10807,32.73569,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":50,"phoneExt":20,"email":51},"Jon Weidanz, PhD","817-272-6831","Weidanz@uta.edu",{"facility":5,"status":20,"city":53,"state":37,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Fort Worth","76104",{"type":42,"coordinates":56},[57,58],-97.32085,32.72541,{"lat":58,"lon":57},[61],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100602316","ex-vivo-confocal-imaging-and-proteomic-profiling-to-determine-treatment-response-in-children-with-ibd-100602316",false,"NCT07121920","Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD","A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease","Inclusion Criteria:\n\n\\- Patients must fall into one of the below categories: (i) with suspected and\u002For established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls\n\nExclusion Criteria:\n\n* Those with previous allergy to fluorescein\n* Pregnant and breastfeeding patients","ALL","2 Years","21 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of\u002Fstrongly correlated to clinical response\u002Foutcomes observed.\n\nThe key questions under investigation are:\n\nAim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).\n\nAim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nAim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.",[82,83,84],"IBD (Inflammatory Bowel Disease)","IBD","IBD - Inflammatory Bowel Disease",[86,87,83,88,89],"Ex-vivo","Inflammatory bowel disease","CLE","Confocal laser endomicroscopy","NOT_YET_RECRUITING","2025-08-12",{"date":93,"type":94},"2025-08-14","ACTUAL",{"date":96,"type":76},"2025-09-01",{"date":98,"type":76},"2028-07-01",{"name":5,"class":6},2]