[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflamatory-bowel-disease-crohn39s-and-ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflamatory-bowel-disease-crohn39s-and-ulcerative-colitis":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100631051","efficacy-of-different-biological-treatments-in-patients-with-inflammatory-bowel-disease-after-one-year-of-treatment-in-upper-egypt-100631051",false,"NCT07495644","Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt","1. Inclusion Criteria: 1) Age ≥ 18 years; 2) Patients with moderate-to-severe ulcerative colitis, defined as a clinical Mayo score \\>6 with an endoscopic score of 2-3 3) Patients with moderate-to-severe Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) \\>220 with a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥7 4) Patients receiving adalimumab, infliximab, ustekinumab, or vedolizumab; 5) Patients who had been on the current biologic therapy for between 6 weeks and 12 months; and 6) Biologic-naïve patients (no prior biologic therapy). Patients who did not continue their treatment for 12 months due to primary or secondary treatment failure will be considered not to have achieved endoscopic remission. Additionally, patients who were hospitalized, received corticosteroids, or underwent surgery due to medication failure before 12 months of therapy will be considered treatment failures.\n2. Exclusion Criteria:\n\n   1. Patients with prior biologic therapy (biologic-experienced);\n   2. Patients with incomplete outcome or therapy data;\n   3. Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;\n   4. Pregnant patients;\n   5. Patients with intermittent suspension of therapy during the 12-month period.","ALL","18 Years",{"count":18,"type":19},95,"ESTIMATED","OBSERVATIONAL","To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt",[23],"Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)",[25,26],"Ulcerative colitis","Crohn's disease","NOT_YET_RECRUITING","2026-03-24",{"date":30,"type":31},"2026-03-27","ACTUAL",{"date":33,"type":19},"2026-03-01",{"date":35,"type":19},"2027-06",{"name":37,"class":38},"Assiut University","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100630203","physical-activity-and-fitness-in-pediatric-inflammatory-bowel-disease-100630203","NCT07484620","Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease","Effects of Physical Activity and Physical Fitness on Inflammation, Clinical Outcomes, and Quality of Life in Pediatric Inflammatory Bowel Disease","PAFIT-IBD","Inclusion Criteria:\n\n* Children and adolescents aged 6 to 17 years\n* Confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Clinical remission or mild-to-moderate disease activity\n* Medical clearance to participate in physical activity\n* Ability to complete study assessments and follow-up procedures\n* Written informed consent from a parent or legal guardian and assent from the participant\n\nExclusion Criteria:\n\n* Severe disease activity or acute flare requiring hospitalization\n* Medical contraindications to exercise (e.g., severe cardiopulmonary disease, uncontrolled anemia, significant musculoskeletal conditions)\n* Major surgery within the previous 3 months\n* Participation in another interventional clinical trial\n* Cognitive or behavioral conditions preventing participation\n* Any condition considered unsafe by the investigators or treating physician","6 Years","17 Years",{"count":50,"type":19},100,"INTERVENTIONAL",[53],"NA","Pediatric inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic condition associated not only with intestinal inflammation but also with reduced physical fitness, fatigue, impaired quality of life, and psychosocial difficulties. Although physical activity and physical fitness are recognized as important determinants of health in the general pediatric population, their role as modifiable prognostic factors in children and adolescents with IBD remains insufficiently studied, particularly using objective measures and longitudinal designs in hospital settings.\n\nThe present hospital-based study aims to investigate the effects of physical activity and physical fitness on inflammation, clinical outcomes, and quality of life in children and adolescents with IBD. The project comprises three phases: (1) an observational cross-sectional and longitudinal assessment, (2) a randomized controlled trial (RCT) evaluating a structured physical activity intervention, and (3) a medium-term follow-up at 6-12 months.\n\nPhysical activity will be assessed objectively using accelerometry and subjectively using validated questionnaires. Physical fitness will be evaluated with the ALPHA fitness battery adapted to the hospital setting, with cardiorespiratory fitness assessed by the 20-meter shuttle run test as the primary outcome of the RCT. Clinical outcomes will include objective inflammatory markers (fecal calprotectin and C-reactive protein), disease activity indices (PCDAI or PUCAI), musculoskeletal health, fatigue, cognitive functioning, and health-related quality of life. Nutritional status and dietary quality will also be assessed, and selected biological markers will be analyzed in a subsample.\n\nThe RCT will examine whether a 12-week supervised physical activity program improves cardiorespiratory fitness compared with usual care, and whether changes in fitness are accompanied by improvements in inflammatory burden and patient-reported outcomes. Longitudinal analyses will explore the sustainability of these effects over time.\n\nThis study will provide comprehensive, objective evidence on the role of physical activity and physical fitness as modifiable factors in pediatric IBD. The results are expected to inform clinical practice, support the integration of structured physical activity into multidisciplinary care, and contribute high-quality data for publication in international peer-reviewed journals.",[23,56],"Inflamatory Bowel Disease",[58,59,60,61,62,63,64,65],"Pediatric Inflammatory Bowel Disease","Health-Related Quality of Life","Fecal Calprotectin","Physical Fitness","Cardiorespiratory Fitness","Accelerometry","Cognitive Function","Disease Activity","2026-03-19",{"date":28,"type":31},{"date":69,"type":19},"2026-04-01",{"date":71,"type":19},"2026-12-01",{"name":73,"class":38},"Universidad Complutense de Madrid",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100607098","real-world-study-on-the-safety-and-effectiveness-of-il-23-inhibitors-for-inflammatory-bowel-disease-in-china-100607098","NCT07184138","Real-World Study on the Safety and Effectiveness of IL-23 Inhibitors for Inflammatory Bowel Disease in China","Efficacy and Safety of Interleukin-23 Inhibitors (IL-23i) in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study","Inclusion Criteria:\n\nAdults aged 18 years or older, any gender. Formally diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). Determined by the treating physician to require initiation of IL-23 inhibitor (IL-23i) therapy for the first time.\n\nExclusion Criteria:\n\nCurrently enrolled in or planning to participate in any other interventional clinical study.\n\nContraindications to IL-23i treatment as specified in the drug label. Considered by the investigator to be unsuitable for participation in the study for any reason.",{"count":83,"type":19},178,"Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Interleukin-23 (IL-23), a member of the IL-12 cytokine family, plays a role in maintaining intestinal homeostasis but is also involved in the pathogenesis of IBD. IL-23 is a heterodimer composed of p19 and p40 subunits linked by a disulfide bond. Humanized monoclonal antibodies selectively targeting the IL-23 p19 subunit have emerged as promising therapies for IBD. Recently, selective IL-23p19 inhibitors-risankizumab (Risan) and mirikizumab-have been approved for the treatment of moderately to severely active CD and UC, respectively. In addition, these agents, along with guselkumab (Gus), are undergoing clinical trials for both CD and UC (guselkumab, gus, and mirikizumab for CD; guselkumab and risankizumab for UC). Guselkumab (Gus) and risankizumab (Risan), both targeting the IL-23 p19 subunit, have been approved in China for the treatment of CD, with guselkumab also approved for UC. However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese IBD populations is lacking. This is a multicenter, single-arm, prospective, observational real-world study designed to evaluate the efficacy and safety of IL-23i in adult UC and CD patients in routine clinical practice in China.",[23],[87,88,89],"IL23i","Crohn's disease","Ulcerative Colitis","2025-09-13",{"date":92,"type":31},"2025-09-19",{"date":94,"type":19},"2025-10-01",{"date":96,"type":19},"2028-11-01",{"name":98,"class":38},"Sixth Affiliated Hospital, Sun Yat-sen University"]