[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PhoenixLAB srls\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":43,"locationsCount":5},"100656527","ex-vivo-comparison-of-combination-versus-single-therapeutic-pathway-inhibition-in-human-intestinal-mucosa-from-patients-with-inflammatory-bowel-disease-100656527",false,"NCT07824726","Ex Vivo Comparison Of Combination Versus Single Therapeutic Pathway Inhibition In Human Intestinal Mucosa From Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Patients of at least 18 years of age\n* Able to comply with the study procedures and to sign an informed consent form\n* Established diagnosis of UC or CD, with indication to start any biological or small molecule agents as per standard of care:\n\nUC patients with a clinical indication to start biologics or small molecules as per standard of care, with a Total Mayo Score of 6-12 (moderate-severe disease) and an endoscopic subscore ≥ 2; CD patients with a clinical indication to start biologics or small molecules as per standard of care, with a clinical CDAI score of 220-600 (moderate-severe disease) and endoscopic evidence of active mucosal inflammation\u002Fulceration upon baseline examination;\n\n\\- Patients with IBS or individuals undergoing colonoscopy for CRC prevention or routine surveillance, with no prior diagnosis of inflammatory bowel disease and no endoscopic evidence of intestinal mucosal inflammation.\n\nExclusion Criteria:\n\n* Absolute contraindications to colonoscopy procedures\n* UC or CD patients in endoscopic remission\n* IBS or patients undergoing CRC prevention surveillance with inflamed mucosa during the endoscopy\n* Patients of at least 18 years of age unable to comply with the study procedures and to sign an informed consent form\n* Pregnancy or breastfeeding",true,"ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to evaluate whether simultaneously targeting three inflammatory pathways (TL1A, IL-23, and α4β7) produces a stronger anti-inflammatory effect in intestinal tissue from patients with Inflammatory Bowel Disease (IBD) compared with targeting individual pathways. The study aims to investigate whether this combined approach may help overcome limitations associated with single-pathway inhibition.\n\nThis is a single-center, interventional ex vivo study conducted at IRCCS Ospedale San Raffaele. The study includes 30 participants divided into three cohorts: 10 patients with Ulcerative Colitis, 10 patients with Crohn's Disease, and 10 non-IBD control participants.\n\nParticipant involvement is limited to a single day and is integrated into a clinically indicated, routinely scheduled colonoscopy and routine phlebotomy. During the scheduled colonoscopy, 8 additional mucosal biopsies are collected for research purposes, together with an additional 2 mL blood sample. No additional endoscopic procedure or separate study visit is required.\n\nNo investigational drug or treatment is administered directly to participants. The collected intestinal biopsies are instead treated ex vivo in the laboratory with ATTO-1091, individual pathway inhibitors, or control conditions for 16 hours.\n\nBiological and molecular responses are evaluated using laboratory techniques including ELISA and RNA sequencing to assess inflammatory markers and gene expression. Laboratory personnel performing molecular and transcriptomic analyses are blinded to participants' clinical profiles until final data analysis.",[26,27,28],"Ulcerative Colitis (UC)","IBD (Inflammatory Bowel Disease)","Crohn Disease (CD)",[30,31,32,33,34],"IBD","Ulcerative Colitis","Crohn's Disease","Combination Therapy","Ex Vivo Human Organ Culture","NOT_YET_RECRUITING","2026-09-16",{"date":38,"type":39},"2026-09-17","ACTUAL",{"date":41,"type":20},"2026-10-01",{"date":41,"type":20},{"name":44,"class":45},"PhoenixLAB srls","OTHER",""]