[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,71,93,119,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580977","impact-of-ibd-activity-on-frailty-in-patients-over-60-years-100580977",false,"NCT06844318","Impact of IBD Activity on Frailty in Patients Over 60 Years","Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years","FRAGIL","Inclusion Criteria:\n\n* Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.\n* Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and\u002For biologics) due to clinical activity based on PRO2 scales (UC: PRO \\>4; CD: PRO2 \\>14) and\u002For biological activity (fecal calprotectin ≥500 mg\u002Fkg, C-reactive protein ≥10 mg\u002FL).\n* Signed informed consent for inclusion.\n\nExclusion Criteria:\n\n* Lack or withdrawal of informed consent.\n* Unclassified\u002Findeterminate colitis.\n* Change in medical treatment solely due to adverse events.\n* Initiation of treatment only with salicylates and\u002For topical steroids for disease activity.\n* Treatment intensification to manage disease activity.\n* Patients with an ostomy.\n* Comorbidities with a life expectancy of less than one year.","ALL","60 Years",{"count":20,"type":21},153,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.\n\nThe main questions it aims to answer are:\n\n1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease?\n2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.",[26],"IBD",[28],"eldearly","RECRUITING","2026-05-06",{"date":32,"type":33},"2026-05-07","ACTUAL",{"date":35,"type":33},"2025-04-14",{"date":37,"type":21},"2027-05",{"name":39,"class":40},"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa","OTHER",34,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100612058","phase-4-immunosuppressant-discontinuation-in-elderly-patients-with-ulcerative-colitis-and-long-term-remission-100612058","NCT07248644","Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission","Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients With Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA)","IDEA","Inclusion Criteria:\n\n1. Male or female patients aged ≥60 years at screening.\n2. Established diagnosis of ulcerative colitis according to ECCO criteria.\n3. Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice.\n4. Treatment with a thiopurine (azathioprine 1-2.5 mg\u002Fkg\u002Fday or mercaptopurine 0.75-1.5 mg\u002Fkg\u002Fday) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months.\n5. In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months.\n6. Clinical remission (at the discretion of the investigator) for at least 3 years, without the need for treatment with oral or intravenous steroids or biological agents (topical rectal treatments are permitted as well as oral mesalazine if the dose has remained stable over the past 12 months).\n7. Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice.\n8. Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values \\\u003C150 mg\u002Fkg during screening.\n9. Written informed consent.\n\nExclusion Criteria:\n\n1. Ulcerative proctitis (maximum observed extension \\\u003C25 cm throughout the course of the disease)\n2. History of colectomy or imminent need for surgery.\n3. Presence of ileoanal reservoir\n4. History of complex perianal disease\n5. Intolerance to oral 5-ASA treatment\n6. Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition.\n7. Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg\u002FdL (estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002F1.73 m²).\n8. Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT \\> 2X the upper limit of normal (ULN) at screening.\n9. Hematologic abnormalities at screening, defined as any of the following: absolute neutrophil count \\\u003C 1,500 cells\u002Fmm³, lymphocytes \\\u003C 500 cells\u002Fmm³, platelets \\\u003C 120,000 cells\u002Fmm³, or haemoglobin \\\u003C 12 g\u002FdL (females) \u002F \\\u003C 13 g\u002FdL (males).\n10. Any condition that in the investigator's opinion may compromise study participation.",{"count":51,"type":21},304,"INTERVENTIONAL",[54],"PHASE4","IDEA is a Phase IV, prospective, randomised, open-label, multicentre clinical trial designed to evaluate the safety and efficacy of withdrawing thiopurines in elderly (≥60 years) patients with ulcerative colitis (UC) who are in sustained clinical and biological remission. The study compares discontinuation of thiopurines versus continuation while maintaining background mesalamine therapy over 24 months of treatment.",[57],"Ulcerative Colitis (UC)",[59,60,61],"thiopurines","5-ASA","mesalazine","NOT_YET_RECRUITING","2026-04-10",{"date":65,"type":33},"2026-04-15",{"date":67,"type":21},"2026-05-01",{"date":69,"type":21},"2027-09",{"name":39,"class":40},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100492945","immunological-characteristics-of-preclinical-ibd-100492945","NCT05698745","Immunological Characteristics of Preclinical IBD","Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease","Inclusion criteria\n\nPatients from cohort A will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).\n* Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.\n* The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nPatients from cohort B will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* Recent diagnosis of IBD, with \\\u003C3 months from symptoms onset.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nPatients from cohort C will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nExclusion criteria\n\nPatients from cohort A will be excluded if they fulfill any the following exclusion criteria:\n\n* Identification of any enteropathogen in the stool culture.\n* Isolated findings of acute inflammatory infiltrate without signs of chronicity.\n* Previous or current diagnosis of microscopic colitis.\n* Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.\n\nPatients from cohort B will be excluded if they fulfill any the following exclusion criteria:\n\n\\- Previous use of immunomodulators or biologics for any condition.\n\nPatients from cohort C will be excluded if they fulfill any the following exclusion criteria:\n\n* Any gastrointestinal symptoms at baseline.\n* Previous use of immunomodulators or biologics for any condition.",true,"18 Years",{"count":81,"type":21},450,"The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).",[84,85,26],"Crohn Disease","Ulcerative Colitis",{"date":65,"type":33},{"date":88,"type":33},"2024-06-01",{"date":90,"type":21},"2038-07-01",{"name":39,"class":40},25,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":52,"phases":104,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100387907","prospective-multicenter-randomized-comparative-study-of-the-treatment-of-de-novo-stenosis-in-chrons-disease-100387907","NCT04330846","Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.","Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Crohn's Disease. Endoscopic Treatment (Self-expanding Metal Prosthesis\u002FBallon Dilation) vc Surgical Resection (ENDOCIR STUDY)","ENDOCIR","Inclusion Criteria:\n\n* 18-80 years of age.\n* Crohn's disease with predominantly de novo fibrotic stenosis\\* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).\n* Patients with known stenosis previously treated with stenting and\u002For dilation performed over one year before the date of inclusion.\n* Symptomatology of intestinal occlusion-subocclusion.\n* Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).\n* Stenosis length \\\u003C 10 cm.\n* Maximum of 2 stenoses.\n* Informed consent from patient.\n\nExclusion Criteria:\n\n* No informed consent from the patient.\n* Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.\n* Patients with known stenosis previously treated with stenting and\u002For dilation performed \\\u003C 1 year before the date of inclusion.\n* Pregnancy or lactation.\n* Any clinical situation that prevents the performance of endoscopy or surgery.\n* Stenosis not accessible by endoscopy.\n* Asymptomatic patient.\n* Stenosis length ≥ 10 cm.\n* Presents with \\> 2 stenoses.\n* Severe coagulation disorders (platelets \\\u003C 70000; INR \\> 1.8).","80 Years",{"count":103,"type":21},40,[105],"NA","Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.",[84],[109],"crohn","2025-08-18",{"date":112,"type":33},"2025-08-19",{"date":114,"type":33},"2022-11-29",{"date":116,"type":21},"2027-04-01",{"name":39,"class":40},16,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":23,"phases":4,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100552156","an-active-surveillance-post-authorization-study-to-characterize-the-safety-of-tofacitinib-in-patients-with-moderately-to-severely-active-ulcerative-colitis-in-the-real-world-setting-using-data-from-the-united-registries-for-clinical-assessment-and-research-ur-care-in-the-european-union-eu-100552156","NCT06469424","An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)","PASS TOFA","Inclusion Criteria:\n\n* Adult patients aged ≥18 years,\n* With Ulcerative colitis diagnosis per ECCO guidelines,\n* Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,\n* With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria\n* Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date \\[i.e. date of first prescription for tofacitinib\\].",{"count":127,"type":21},104,"12 Months","The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis \\[DVT\\] and pulmonary embolism \\[PE\\]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.",[85],[132],"prospective observational study with medication","2024-06-17",{"date":135,"type":33},"2024-06-21",{"date":137,"type":33},"2024-01-11",{"date":139,"type":21},"2026-03-31",{"name":39,"class":40},5,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":148,"minAge":79,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":23,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100354385","safety-of-ibd-drugs-during-pregnancy-and-breastfeeding-mothers-and-babies-outcomes-dumbo-registry-100354385","NCT03894228","Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)","Inclusion Criteria:\n\n* Patients over 18 years of age diagnosed with IBD.\n* Confirmed pregnancy.\n* Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).\n\nExclusion Criteria:\n\n• Patients who do not accept to participate in the study.","FEMALE",{"count":150,"type":21},1750,"57 Months","This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain.\n\nIn addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.",[154,155],"Inflammatory Bowel Diseases","Pregnancy","2020-02-19",{"date":158,"type":33},"2020-02-21",{"date":160,"type":33},"2019-05-21",{"date":162,"type":21},"2028-03-01",{"name":39,"class":40},73,""]