[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohn-disease-cd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohn-disease-cd":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,46,75,107,131,154,180,200,230,253,272,292,316,337,363,383,407,435,465,486,505,531,551,574,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100640448","phase-4-optimal-care-with-guselkumab-in-crohns-disease--optim-study-a-prospective-open-label-interventional-multicenter-study-100640448",false,"NCT07616687","Optimal Care With Guselkumab in Crohn's Disease \u002F OPTIM Study A Prospective Open Label Interventional, Multicenter Study","Optimal Care With Guselkumab In Crohn's Disease","OPTIM","Inclusion Criteria:\n\n* \\- Patients with a diagnosis of CD according to ECCO guidelines,\n* 18 years of age or older at the time of informed consent,\n* Absence of contraindication to guselkumab,\n* Active disease according to PRO2 (abdominal pain \\> 1 or stool frequency \\> 3), and faecal calprotectin \\> 250 ug\u002Fg,\n* Objective active disease documented within ≤ 2 months by endoscopy or by MRI when not contraindicated, orby IUS),\n* Not currently participating in any interventional research.\n* Patient naïve or exposed to one or more advanced therapy, in accordance with the approved indication for guselkumab in Crohn's disease.\n* Females of childbearing potential must have a negative serum pregnancy test at the baseline Visit.\n\nExclusion Criteria:\n\n* \\- Patient under legal protection,\n* Previous exposure to an anti-IL23\n* Combination of advanced therapy with GUS,\n* Patient with ostomy,\n* Pregnant or breastfeeding woman,\n* Patient with perianal CD predominant disease.\n* Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis","ALL","18 Years",{"count":21,"type":22},210,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Crohn's disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterized by phases of relapse and remission. Tumor necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12\u002F23 are the main therapeutic agents to obtain deep remission and prevent disability. Despite the significant advances these biologics represent in treating inflammatory bowel disease (IBD), many patients experience suboptimal responses, including primary non-response or a loss of effectiveness over time, often leading to treatment discontinuation. For all these medications, a dose-response relationship has been demonstrated and an increase in dose or dosing frequency is recommended. Dose escalation is now an essential therapeutic approach necessary in 30 to 50% of CD patients treated with biologics. This strategy, supported by international guidelines, allows for long-term efficacy to be maintained without compromising safety.\n\nGuselkumab (GUS) is a monoclonal antibody targeting the p19 subunit of IL-23. In a recent phase III trial (GALAXI), GUS demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks \\[q4w\\] and 100 mg every 8 weeks \\[q8w\\]) compared to placebo and ustekinumab. In the GALAXI phase III program, at least 30% of patients did not achieve clinical response after a 12-week intravenous induction, and almost 20% experienced a loss of response by week 44. In these patients, the benefit of an intensified dose of GUS (200 mg q4w) maintenance remains to be determined to guide clinicians in optimizing its use in clinical practice. The investigator aimed to evaluate the one-year effectiveness of GUS in CD in real-world settings and under optimal conditions allowing dose intensification.",[28,29],"Crohn Disease (CD)","Intensification",[31,29,32],"Crohn's disease","Guselkumab","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2026-06-18",{"date":41,"type":22},"2029-03-15",{"name":43,"class":44},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100642703","prospective-evaluation-of-flare-detection-in-ibd-with-digital-biomarkers-bring-your-own-device-study-100642703","NCT07647640","Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study","BYOD","Inclusion Criteria:\n\n* 18 years or older\n* Crohn's Disease or ulcerative colitis\n* Having a smartwatch and\u002For a smartphone\n* Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)\n\nExclusion Criteria:\n\n* No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...",{"count":54,"type":22},600,"OBSERVATIONAL","The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.",[58,59,28],"Inflammatory Bowel Disease (IBD)","Ulcerative Colitis (UC)",[61,62,63],"Inflammatory Bowel Disease","Digital biomarkers","Heart rate variability","NOT_YET_RECRUITING","2026-06-24",{"date":67,"type":37},"2026-06-29",{"date":69,"type":22},"2026-06-15",{"date":71,"type":22},"2027-10-15",{"name":73,"class":44},"Maastricht University Medical Center",3,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100598919","phase-2-hb-admscs-for-the-treatment-of-crohns-disease-100598919","NCT07077746","HB-adMSCs for the Treatment of Crohn's Disease","A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease","Inclusion Criteria:\n\n1. Male and female subjects who are ≥ 18 years old and ≤ 65 years old.\n2. Must be diagnosed with Crohn's Disease at least 6 months prior to the screening visit, as verified by one or more of the following diagnostic criteria present in the participant's medical records:\n\n   1. Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue\n   2. Radiologic Findings within 3 years of screening date: Imaging studies like CT scans or MRI scans of the abdomen and pelvis that indicate bowel wall thickening, strictures, fistulas, and abscesses characteristic of Crohn's disease\n   3. Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates\n   4. Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation\n3. Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.\n4. Subjects without a current established treatment for Crohn's Disease, or if being treated, subjects who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.\n5. Subjects must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. Subjects must acknowledge that they may be removed from participation in the study for failure to maintain their established treatment for Crohn's Disease (or lack thereof).\n6. Subjects must have an elevated CRP value at the screening visit of ≥1 mg\u002FL and\u002For an abnormal ESR value at the screening visit of \\> 15 mm\u002Fhr. for male subjects or \\> 20 mm\u002Fhr. for female subjects.\n7. Subjects must be able to provide the latest (specifically, within 3 years of screening date) diagnostic imaging records for their Crohn's Disease (including but not limited to endoscopy, colonoscopy, MRI scans, ultrasounds, etc.)\n8. Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:\n\n   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   3. Barrier contraceptive methods (condoms, diaphragm, etc.). OR Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:.\n\n   \u003C!-- -->\n\n   1. Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).\n   2. Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).\n   3. Barrier contraceptive methods (condoms, diaphragm, etc.).\n9. Study subjects are able and willing to comply with the requirements of this clinical trial.\n10. Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.\n\nExclusion Criteria:\n\n1. Study subject has any of the following laboratory results at the screening visit:\n\n   1. WBC: \\<3000 cells\u002FμL OR \\>15000 cells\u002FμL (\\<3 K cells\u002FμL or \\>15 K cells\u002FμL)\n   2. Absolute Neutrophil Count: \\<1500 cells\u002FμL\n   3. Sodium: \\<120 mEq\u002FL OR \\>150 mEq\u002FL\n   4. Glucose: \\>150 mg\u002FdL (for fasting subjects)\n   5. Potassium: \\<3.5 mEq\u002FL OR \\>6 mEq\u002FL\n   6. BUN: \\>25 mg\u002FdL\n   7. Creatinine: \\>2 mg\u002FdL\n   8. BUN\u002FCreatinine ratio: \\>50\n2. Study subject has CDAI scores of \\< 150 or \\> 450 at the screening visit.\n3. Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.\n4. Study subject has any of the following cardiovascular issues:\n\n   1. Severe heart failure (e.g., NYHA Class III\u002FIV)\n   2. Uncontrolled arrhythmias\n   3. Recent myocardial infarction (\\<6 months from screening visit)\n   4. Uncontrolled hypertension\n5. Study Subject has any of the following pulmonary diseases:\n\n   1. Severe COPD\n   2. Pulmonary fibrosis\n   3. History of recent (\\<6 months from screening visit) pulmonary embolism or DVT\n6. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:\n\n   1. Diabetes Mellitus\n   2. Rheumatoid Arthritis\n   3. Lupus\n   4. Multiple Sclerosis\n7. Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.\n8. Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)\n9. Study subject has known alcoholic addiction or dependency or has current substance use or abuse.\n10. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.\n11. Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.\n12. Study subject unable to understand and provide signed informed consent.\n13. Study subject unlikely to complete the study or adhere to the study procedures.\n14. Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.\n15. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.\n16. Female subjects who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male subjects who plan to donate sperm during the study within 6 months after the last infusion.","65 Years",{"count":84,"type":22},46,[86],"PHASE2","Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment.\n\nTreatment Duration: 16 weeks\n\nGeneral Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of Crohn's Disease in this subject population.\n\nNumber of Subjects: 46 (23 in each treatment arm)\n\nIndication: Crohn's Disease",[28],[90,91,92,93,94,95,96,97],"Crohn's","Crohn's Disease","Autoimmune","CD","IBD","Inflammatory bowel disease","biologic","stem cell",{"date":99,"type":37},"2026-06-17",{"date":101,"type":22},"2026-07",{"date":103,"type":22},"2027-12",{"name":105,"class":106},"Hope Biosciences Research Foundation","INDUSTRY",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":55,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":128,"locationsCount":45},"100641651","impact-of-advanced-crohns-disease-therapies-on-sleep-quality-100641651","NCT07649408","Impact of Advanced Crohn's Disease Therapies on Sleep Quality","Inclusion Criteria:\n\n* Patients with established diagnosis of Crohn's Disease\n* Patients with active inflammation, defined as HBI score ≥ 5 and either CRP\\>5 or stool calprotectin\\>250 mcg\u002Fgr.\n* Patients starting advanced treatment as part of routine medical care (Anti TNFs, vedolizumab, Ustekinumab, IL-23 inhibitors, Jak inhibitors or S1P inhibitors).\n\nExclusion Criteria:\n\n* Inability to give informed consent and complete the study protocol.\n* Pregnant or lactating women\n* Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: questionnaires, wearing the watch while sleeping.\n* Patients diagnosed with UC or indeterminate IBD.\n* Other sleep disorders Obstructive sleep apnea overactive bladder insomnia shift work disorder restless leg syndrome Periodic limb movement of sleep Narcolepsy\n* Use of sleep medication - such as benzodiazepines or cannabis.\n* Recent abdominal surgery - previous 4 weeks.\n* Severe systemic disease - CVD, Kidney, liver - as jugged by physician's discretion.\n* Patients with ileostomy or short bowl syndrome.",{"count":114,"type":22},30,"26 Weeks","The goal of this observational study is to measure changes in sleep quality before and after starting treatment with advance therapy in adult with Crohn disease. The main question it aims to answer is: what is the association between response to therapy and sleeping patterns? Participants who are about to begin advanced treatment will be asked to wear a Fitbit device before end after treatment initiation to monitor sleep patterns and sleep quality, complete a sleep diary and a sleep quality questionnaire. The follow-up period will last 26 weeks, during which disease severity and response to treatment will be assessed.",[28],[93,119,120,121],"Fitbit","Sleep qulity","Response to treatment","2026-06-14",{"date":124,"type":37},"2026-06-16",{"date":126,"type":37},"2025-08-06",{"date":103,"type":22},{"name":129,"class":130},"Shmuel Kivity, MD","OTHER_GOV",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":140,"studyType":55,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":45},"100643044","individualizing-anti-tnf-therapy-in-patients-with-inflammatory-bowel-disease-100643044","NCT07644117","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease","Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study.","Inclusion Criteria:\n\n* Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)\n* Anti-TNF naïve\n* Clinically active disease (HBI\\>5 for CD, p-MS≥ 3 for UC)\n* Elevated inflammatory indices CRP\\>10 or fecal calprotectin\\>250\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Anti-TNF experienced\n* Unable to complete the study protocol",{"count":139,"type":22},40,"52 Weeks","This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.\n\nParticipants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.",[143,28,59],"IBD (Inflammatory Bowel Disease)",[94,145,121],"Anti-TNF","2026-06-11",{"date":148,"type":37},"2026-06-12",{"date":150,"type":37},"2025-01-04",{"date":152,"type":22},"2028-12",{"name":129,"class":130},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100641957","regenerative-endoscopy-in-refractory-perianal-crohns-disease-100641957","NCT07652632","Regenerative Endoscopy in Refractory Perianal Crohn's Disease","Autologous Mechanical tSVF Injection in Refractory Perianal Fistulizing Crohn's Disease: A Single Arm Pilot Feasibility Study","REPAIR-pCD","Inclusion Criteria:\n\n* Age 18-65 years\n* Crohn's disease with complex perianal fistula (≥1 secondary tract or internal opening involvement)\n* Refractory to ≥1 biologic and\u002For ≥1 prior sphincter sparing procedure\n* No abscess on screening MRI\n* Mild or no proctitis on endoscopic assessment\n* CDAI \\\u003C220\n* Stable IBD therapy ≥8 weeks\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Rectovaginal fistula\n* Severe active proctitis requiring urgent escalation\n* Malignancy in tract or pelvic region\n* Pregnancy or lactation\n* ASA IV status or bleeding disorder\n* MRI contraindications",{"count":163,"type":22},50,[165],"NA","Perianal fistulizing Crohn's disease (pCD) represents a severe phenotype of Crohn's disease, affecting approximately 20-30% of patients and resulting in chronic drainage, recurrent sepsis, impaired continence, and reduced quality of life. Despite optimization of biologics, antibiotics, and surgical drainage, durable healing remains difficult to achieve. Conventional surgical approaches such as curettage or seton management alone yield modest remission rates, and repeated procedures may compromise sphincter integrity.\n\nAutologous mechanically processed tissue stromal vascular fraction (tSVF) is derived from adipose tissue using non enzymatic methods and can be prepared and reinjected during the same operative session. Unlike culture-expanded or enzymatically isolated cell products, mechanical tSVF retains a native adipose micro architecture containing stromal cells, perivascular elements, endothelial progenitors, extracellular matrix components, and bioactive cytokines. This heterogeneous microenvironment is hypothesized to exert immunomodulatory, pro angiogenic, and regenerative effects that may enhance tract healing while preserving sphincter function.\n\nMechanical processing avoids enzymatic digestion, cell expansion, and complex laboratory infrastructure, making it potentially more feasible and cost effective in real world settings. However, high quality prospective data evaluating mechanically processed autologous tSVF specifically in refractory complex pCD remain limited, and feasibility data are required before undertaking a large randomized trial.\n\nThis single arm pilot feasibility study is therefore designed to evaluate procedural feasibility, safety, and preliminary signals of clinical and radiological healing following mechanical tSVF injection in refractory complex perianal Crohn's disease. The results will inform design parameters, outcome variability, and sample size estimation for a future definitive multicenter trial.",[28,168],"Perianal Crohns Disease",[170,171],"tSVF","REPAIR-CD",{"date":99,"type":37},{"date":174,"type":37},"2026-04-20",{"date":176,"type":22},"2028-03",{"name":178,"class":44},"Asian Institute of Gastroenterology, India",2,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":198,"locationsCount":45},"100642804","phase-2-db-3q-for-the-treatment-of-medically-refractory-crohns-disease-100642804","NCT07625293","DB-3Q for the Treatment of Medically Refractory Crohn's Disease","A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease","Inclusion Criteria:\n\n1. Written informed consent from participant\n2. Males and females 18-75 years of age\n3. Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunological therapy with a next step of subtotal colectomy or escalation in medical management\n4. Active CD as defined by a CDAI score ≥ 220 and\u002For SES-CD score ≥ 4\n5. Exposure to corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary\n6. If receiving conventional immunomodulators (i.e., azathioprine \\[AZA\\], mercaptopurine \\[6-MP\\], or methotrexate \\[MTX\\]), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to initial administration of IMP\n7. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to initial administration of IMP\n8. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg\u002Fday prednisone or its equivalent and must have been stable for at least 4 weeks prior to initial administration of IMP\n9. If receiving budesonide, the dose must have been stable for at least 2 weeks prior to initial administration of IMP\n10. If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks prior to initial administration of IMP\n11. The following medications\u002Ftherapies must have been discontinued before initial administration of IMP:\n\n    1. Monoclonal therapy (e.g., adalimumab, certolizumab, infliximab, risankizumab, ustenkinumab, and vedolizumab) for at least 8 weeks\n    2. Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks\n    3. 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks\n    4. JAK inhibitors (e.g., upadacitinib) must have been discontinued for at least 4 weeks\n    5. Rectal corticosteroids (i.e., corticosteroids \\[including budesonide\\] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks\n    6. Rectal 5-ASA compounds (i.e., 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks\n    7. Parenteral corticosteroids for at least 2 weeks\n    8. Total parenteral nutrition for at least 2 weeks\n    9. Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks\n12. No colonic dysplasia and malignancy as ruled out by colonoscopy within 90 days prior to initial administration of IMP\n13. If participant is of reproductive capacity, willing to use adequate birth control measures while in the study\n\nExclusion Criteria:\n\n1. Lack of informed consent\n2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding\n3. Clinically significant medical conditions within the six months before initial administration of IMP: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the participant\n4. Confirmed Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infections\n5. Aspartate aminotransferase (AST) or Alanine transaminase (ALT) greater than 3 times the upper limit of normal at screening\n6. Abnormal basic laboratory values with the following cut-offs:\n\n   1. Alkaline phosphate \\> 200 U\u002FL\n   2. WBC \\>13 109\u002FL\n   3. Hemoglobin \\\u003C 7 g\u002FdL\n   4. Platelets \\\u003C 50 or \\> 109\u002FL\n   5. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2\n   6. HbA1C \\> 8%\n7. Prothrombin time (PT), partial thromboplastin time (aPTT) or international normalized ratio (INR) greater than 1.5 times the upper limits of normal at screening\n8. Clinically significant abnormal vital signs prior to initial administration of IMP as defined by:\n\n   1. Systolic blood pressure \\>160 or \\\u003C90 mmHg\n   2. Diastolic blood pressure \\>90 or \\\u003C60 mmHg\n   3. Pulse \\\u003C55 or \\>105 bpm\n   4. Respiratory Rate (RR) \\\u003C9 and \\>25 breaths per minute\n   5. Temperature \\>100.4 degrees Fahrenheit\n   6. SpO2 \\\u003C92%\n9. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment\n10. Ulcerative colitis or indeterminate colitis\n11. Suspicion or presence of an intraabdominal or perianal abscess\n12. Microscopic, ischemic or infectious colitis\n13. Neoplasia of the colon on preoperative biopsy\n14. Evidence of colonic perforation\n15. Colonic stricture that unable to pass an adult colonoscope\n16. Three or more prior small bowel resections\n17. Presence of an ostomy\n18. Massive hemorrhage from the colon requiring emergent surgery in the 6 months prior to screening\n19. Fulminant colitis requiring emergency surgery\n20. Concurrent active clostridium difficile infection of the colon\n21. Concurrent Cytomegalovirus infection of the colon via colonic biopsy with CMV stain taken within 90 days prior to screening\n22. Active or latent tuberculosis\n23. Unable to wean off corticosteroids\n24. Primary sclerosing cholangitis\n25. History of or current alcohol or drug abuse or dependence, recreational use of illicit drugs or prescription medications, or use of medical marijuana within 90 days prior to screening\n26. Known allergy to local anesthetics\n27. Concurrent use of anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix)\n28. History of known inherited or acquired hypercoagulable states.\n29. Electrocardiogram demonstrating cardiac arrhythmia, except for sinus tachycardia within the predefined limit of no greater than 105 bpm.\n30. Use of investigational therapy or treatment within 6 months prior to initial IMP administration","75 Years",{"count":189,"type":22},36,[86],"This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.",[28],"2026-06-10",{"date":148,"type":37},{"date":196,"type":22},"2026-06",{"date":103,"type":22},{"name":199,"class":106},"Direct Biologics, LLC",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":93,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":45},"100632169","phase-4-tnfi-plus-low-dose-upadacitinib-vs-tnfi-intensification-in-crohns-disease-with-suboptimal-response-100632169","NCT07510191","TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response","Efficacy and Safety of Standard-Dose TNF Inhibitor Plus Low-Dose Upadacitinib Versus TNF Inhibitor Intensification for Crohn's Disease With Suboptimal Response to Standard-Dose TNF Inhibitors: A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age 18-65 years, regardless of sex.\n2. Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria.\n3. Prior exposure to TNFα inhibitors (including infliximab, adalimumab, or its biosimilars) for at least 12 weeks, and currently receiving a standard-dose treatment regimen. After comprehensive evaluation by the investigators, the participant is considered to have partial response to TNFα inhibitor therapy with residual room for optimization. This is defined as failure to achieve the prespecified treatment target after standard induction and\u002For maintenance therapy, while still being considered by the investigator to have potential for further optimization. Eligible participants should meet either of the following: (1)Loss of response (LOR): The participant previously achieved clinical remission and\u002For objective improvement after TNFα inhibitor treatment, but subsequently developed recurrent disease activity during the maintenance phase. Based on the prior response trajectory, current objective evidence of disease activity, treatment adherence, and available reactive therapeutic drug monitoring (TDM) results, the investigator judges that the participant has not developed complete pharmacodynamic failure to TNFi, and still has room for further therapeutic optimization. (2)Primary inadequate response: After completion of standard induction therapy, the participant achieved some but insufficient improvement compared with pretreatment baseline, defined as meeting at least one of the following: ①CDAI decrease of ≥100 points, but CDAI remains ≥150, ②SES-CD decrease of ≥50%, but active ulcerative lesions persist or endoscopic remission has not been achieved, ③CRP and\u002For FCP decrease of ≥50%, but inflammatory markers have not normalized (e.g., FCP ≥250 μg\u002Fg), ④Based on a comprehensive assessment of symptoms, endoscopy, inflammatory biomarkers, and imaging, the investigator determines that the participant has achieved partial response to TNFi but has not reached the anticipated treatment target, with further room for optimization.\n4. Active Crohn's disease with objective evidence of active inflammation, defined as meeting all of the following: 150 ≤ CDAI \\\u003C 450; at least one of the following objective indicators of active inflammation: (1)Endoscopy showing active ulcerative lesions, (2)Elevated inflammatory markers such as C-reactive protein (CRP), (3)Fecal calprotectin (FCP) ≥250 μg\u002Fg, (4)Imaging evidence of active intestinal inflammation, such as CTE, MRE, or intestinal ultrasound.\n5. At enrollment, the participant must simultaneously meet both requirements:\n\n   Partial response to TNFα inhibitor therapy with residual room for optimization, and\n6. Objective evidence of active inflammation at the current active stage of CD. Baseline TDM and pharmacokinetic assessment are feasible at enrollment, and relevant results may be used for baseline stratification, efficacy analysis, and exploratory research.\n7. The participant fully understands the study objectives, procedures, and potential risks, voluntarily agrees to participate, and has signed the written informed consent form.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization.\n2. Documented immunogenic clearance confirmed by therapeutic drug monitoring (TDM), defined as positive anti-drug antibodies against a TNFα inhibitor with extremely low or undetectable trough drug levels, and judged by the investigator to be unsuitable for continued treatment with the original TNFα inhibitor.\n3. Current symptoms are judged, after comprehensive evaluation, to be caused primarily by non-inflammatory factors, with no objective evidence of active inflammation, such as irritable bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, or other non-inflammatory causes.\n4. Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment.\n5. Presence of severe intestinal complications rendering the participant unsuitable for this study, including but not limited to inadequately controlled active intra-abdominal abscess, intestinal perforation, severe stricture requiring urgent surgical intervention, or severe active intestinal fistula.\n6. Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect efficacy assessment or safety evaluation.\n7. Active infection or high risk of severe infection, including but not limited to active tuberculosis, uncontrolled serious bacterial\u002Ffungal\u002Fviral infection, active herpes zoster, HBV reactivation, HIV infection, or other clinically significant immunodeficiency states.\n8. Severe dysfunction of major organs, such as significant hepatic impairment, severe renal insufficiency, severe cardiac insufficiency, or other serious underlying diseases judged by the investigator to make participation inappropriate.\n9. History of gastrointestinal malignancy, or presence of any other malignant disease that may significantly affect study safety or efficacy assessment.\n10. Pregnant or breastfeeding women, or women planning pregnancy who are unwilling to use effective contraception during the study period.\n11. Severe psychiatric or neurologic disorders that may impair the ability to provide informed consent, adhere to treatment, or complete study follow-up.\n12. Participation in another interventional clinical study within 30 days prior to enrollment, where the prior intervention may affect the efficacy or safety assessment of this study.\n13. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment in this study.",{"count":208,"type":22},312,[25],"This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score \\\u003C150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.",[28],[213,214,215,216,217,218,219,220],"Crohn Disease","TNF inhibitor","Infliximab","Adalimumab","Upadacitinib","Dose intensification","Dual-target therapy","Multicenter randomized controlled trial","2026-06-05",{"date":223,"type":37},"2026-06-09",{"date":225,"type":37},"2026-03-01",{"date":227,"type":22},"2029-12-31",{"name":229,"class":44},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100590859","evaluation-of-therapeutic-strategy-to-prevent-crohns-disease-endoscopic-postoperative-recurrence-based-on-early-dosage-of-faecal-calprotectin-100590859","NCT06972901","Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin","DESTINY II","Inclusion Criteria:\n\n* Patients with an established diagnosis of CD according to ECCO guidelines\n* Adult Crohn's disease (age ≥ 18 years)\n* Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions\n* With an anastomosis that can be reached by ileocolonoscopy\n* With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel \\> 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery\n* No contraindication to ustekinumab treatment\n* Patient capable of giving consent\n* Patient covered by the French healthcare system\n\nExclusion Criteria:\n\n* Permanent stoma\n* Total colectomy\n* Uncontrolled postoperative infectious complication\n* Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age\n* Refusal to participate in the study\n* Persons deprived of their liberty by judicial or administrative decision\n* Minors\n* Vulnerable protected adults (under guardianship, curatorship, or legal protection)",{"count":238,"type":22},42,[165],"Crohn's disease (CD) (\\> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): \\> 40% and \\> 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to \\> 40% clinical POR despite therapeutic escalation (90 mg\u002F4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.",[28,242,243],"Ileocolic Resection","Post-endoscopic Operative Reccurence","2026-06-03",{"date":221,"type":37},{"date":247,"type":37},"2025-10-13",{"date":249,"type":22},"2027-03-01",{"name":251,"class":44},"University Hospital, Clermont-Ferrand",8,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":74},"100591163","phase-2-moving-beyond-inflammation-as-a-therapeutic-target-for-crohns-disease-100591163","NCT06976853","Moving Beyond Inflammation as a Therapeutic Target for Crohn's Disease","Inclusion Criteria:\n\n1. Subjects 18 to 80 years of age, inclusive, at the time of consent\n2. Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology\n3. Active ileal or ileocolonic inflammation on colonoscopy defined as\n\n   1\\. Ileal SES-CD \\> 4 with ulcer subscore \\> 1 (ulcers \\> 5mm)\n4. Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.\n\n   1. Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab\n   2. Anti-integrin agent: vedolizumab\n   3. Anti-IL12\u002F23 agent: Ustekinumab\n   4. Anti-IL23: Risankizumab, Guselkumab, Mirikizumab\n   5. JAK inhibitor: Upadacitinib\n5. In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease\n6. In females: compliance to recommended birth control requirements\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 or \\> 80 years\n2. Pregnant or Breastfeeding female\n3. Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening\n4. BMI \\\u003C 25\n5. Current or previous diagnosis of anorexia nervosa\n6. Type 1 or Type 2 diabetes\n7. Use of concomitant hypoglycemic agents\n8. Personal or family history of medullary thyroid carcinoma\n9. History of multiple endocrine neoplasia\n10. Known serious hypersensitivity to tirzepatide or any of its excipients\n11. Have functional or post-operative short-bowel syndrome\n12. Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion\n13. Active treatment with steroids\\*\n14. Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment\n15. Current stricture not passable with an endoscope\n16. Impending need for surgery per investigator\n17. Have an ileostomy or a colostomy\n18. In females: refusal to comply to recommended birth control requirements \\*Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients","80 Years",{"count":261,"type":22},60,[86],"The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.",[28],{"date":221,"type":37},{"date":267,"type":37},"2025-05-13",{"date":269,"type":22},"2028-08",{"name":271,"class":44},"Washington University School of Medicine",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100638889","phase-1-tolerance-of-local-administration-of-cryopreserved-autologous-stromal-vascular-fraction-combined-with-micrograft-for-the-treatment-of-refractory-ano-perineal-fistulas-in-crohns-disease-100638889","NCT07629245","Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease","ADICROHN3","Inclusion Criteria:\n\n* (1) Signing of a consent form.\n* (2) Patients with Crohn's disease diagnosed at least 6 months prior, in accordance with clinical, endoscopic, histological, and\u002For radiological criteria.\n* (3) Patients previously enrolled in or treated as part of the ADICROHN 2 study.\n* (4) Non-active or mildly active luminal Crohn's disease, defined by a CDAI score ≤ 220.\n* (5) Patients who failed to respond to the ADICROHN-2 protocol, defined by the persistence of anoperineal fistula(s) at the end of the ADICROHN-2 study and their persistence at the time of enrollment.\n* (6) Patients who achieved success (combined remission) at the end of the ADICROHN-2 study but who have a recurrence of anoperineal fistula(s) at the time of enrollment.\n* (7) Sufficient quantity of cryopreserved cells to allow for the innovative treatment, based on the number of fistulas to be treated.\n* (8) Patients over 18 years of age.\n* (9) Good general health based on medical history and clinical examination.\n* (10) Women of childbearing age must have a negative pregnancy test (serum or urine; detection threshold: 25 mIU hCG\u002Fml). Patients of both sexes must use a reliable method of contraception.\n* (11) Enrollment in a social security program.\n\nExclusion Criteria:\n\n* (1) Active, primarily luminal Crohn's disease requiring immediate treatment.\n* (2) Patients who experienced intolerance to the advanced therapy medicinal product during the ADICROHN-2 study.\n* (3) Presence of an abscess or collections \\> 2 cm at the time of enrollment, unless this issue is resolved during the fistula preparation period.\n* (4) Rectal and\u002For anal stenosis and\u002For active proctitis resulting in a limitation of the surgical procedure.\n* (5) Patients currently receiving corticosteroids or who have received them within the four weeks prior to the injection of the investigational product.\n* (6) Malignant tumors or a history of malignant tumors within the past 5 years.\n* (7) Congenital or acquired immunodeficiency.\n* (8) Contraindications to local anesthetics and gadolinium (MRI contrast agent).\n* (9) Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical device or material \\[e.g., insulin pump\\], orthopedic medical prostheses.\n* (10) Treatment with darvadstrocel administered \\\u003C 6 months prior to enrollment)\n* (11) Contraindications to general anesthesia.\n* (12) BMI \\\u003C 18 kg\u002Fm² to ensure an adequate amount of abdominal adipose tissue or other subcutaneous adipose tissue accessible via manual liposuction.\n* (13) Coagulation disorders that contraindicate surgery.\n* (14) Known hypersensitivity to human albumin.\n* (15) Participation in another clinical trial (excluding observational studies).\n* (16) Persons protected under Articles L1121-5, L1121-6, and L1121-8 of the Public Health Code (pregnant or breastfeeding women, persons deprived of liberty by judicial decision, persons in situations of social vulnerability, adults who are legally incapacitated or unable to give informed consent).",{"count":7,"type":22},[281,86],"PHASE1","The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.\n\nIts design is supported by the following elements:\n\n* The results of the ADICROHN pilot study (EudraCT No. 2013-002602-31) and our 3-year study, which demonstrate an excellent safety profile with a promising efficacy signal.\n* Data from the literature confirming that cryopreservation of FVS does not compromise the clonogenic and differentiation potential of mesenchymal progenitors, nor its regenerative effect.\n* The ongoing ADICROHN-2 study (PHRC N 2019; EudraCT No. 2019-001948-21) confirming the feasibility of patient recruitment, mastery of the therapeutic approach, and the absence of adverse events related to the experimental treatment.\n* The opportunity for a second FVS injection for patients initially treated but who did not respond to the treatment.\n* The opportunity for a first FVS injection in patients in the placebo arm, thereby providing access to an innovative therapy available to patients included in this trial who are untreated and remain refractory to standard care.\n\nTo avoid compromising the results of the ongoing ADICROHN-2 study, enrolled patients will remain blinded to the treatment arm to which they belonged in the ADICROHN-2 study.",[28],"2026-06-01",{"date":221,"type":37},{"date":287,"type":37},"2025-12-30",{"date":289,"type":22},"2028-06-29",{"name":291,"class":44},"Assistance Publique Hopitaux De Marseille",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":18,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":45},"100640283","leucine-rich-2-glycoprotein-correlation-with-clinical-endoscopic-and-histological-disease-activity-of-ibd-in-a-european-context-100640283","NCT07621783","Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context","Leucine-rich α2-glycoprotein Correlation With Clinical, Endoscopic and Histological Disease Activity of IBD in a EuRopean Context: LEADER Trial.","LEADER","Inclusion Criteria:\n\n1. ≥18 years\n2. Patient with confirmed diagnosis of IBD\n3. Patient with planned endoscopy (ileocolonoscopy for Crohn's disease (CD)\u002Fulcerative colitis (UC) or sigmoidoscopy for UC) for the assessment of endoscopic disease activity according to routine practice\n4. willing to provide informed consent\n\nExclusion Criteria:\n\n1. Patient with IBD unspecified\n2. Patient with ileo- or colostomy\n3. Patient with total colectomy\n4. Women that are pregnant","16 Years",{"count":302,"type":22},100,"Prospectively study the correlation between Leucine-rich α2-glycoprotein (LRG) and clinical\u002Fendoscopic\u002Fhistological disease activity in patients with inflammatory bowel disease (IBD) in Europe.",[28,59],[306],"Crohn; ulcerative colitis, LRG, endoscopic remission, endoscopic activity, PRO, quality of life","2026-05-29",{"date":309,"type":37},"2026-06-02",{"date":311,"type":37},"2026-05-01",{"date":313,"type":22},"2026-12-31",{"name":315,"class":44},"Imelda GI Clinical Research Center",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100620855","a-prospective-randomised-study-of-treatment-selection-based-on-epigenetic-markers-versus-standard-of-care-treatment-selection-in-adults-with-crohns-disease-100620855","NCT07363044","A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease","OMICROHN","Inclusion Criteria:\n\nParticipants must meet all of the following criteria for enrolment into the study:\n\n1. Aged 18 years or older at the time of informed consent.\n2. Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).\n3. Active CD, as defined by HBI \\> 6 and SES-CD ≥ 6 for colitis\u002Fileocolitis and ≥ 4 for ileitis only.\n4. Eligible to receive either VDZ and\u002For UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.\n5. Must meet all eligibility criteria for biologic therapy initiation as per local SOC, including absence of chronic\u002Fopportunistic infections as demonstrated by local protocols for human immunodeficiency virus, tuberculosis, active cytomegalovirus, hepatitis B and C, and Clostridioides difficile infection. Local vaccination protocols apply as per SOC.\n6. Nonpregnant and nonlactating. Participants of childbearing potential must agree to follow local SOC guidelines for use of biologics in pregnancy\u002Flactation, including appropriate contraception, during the study; must agree to avoid becoming pregnant from the time of informed consent up until Week 26.\n7. If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening.\n8. If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:\n\n   * The dose is up to a maximum of prednisone ≤ 40 mg\u002Fday or budesonide ≤ 9 mg\u002Fday or equivalent.\n   * The dose has been stable for ≥ 2 weeks prior to screening.\n   * The participant is willing to initiate a corticosteroid taper within 2 weeks after initiating biologic treatment.\n9. In the opinion of the investigator, the participant is able to understand and comply with protocol requirements including treatment as assigned per the protocol.\n10. Able to participate fully in all aspects of this clinical study. Full comprehension of consent language and informed consent must be obtained from the participant, or the participant's legally acceptable representative, and documented\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are to be excluded from the study:\n\n1. Prior treatment with VDZ or UST.\n2. Prior treatment with more than 1 advanced therapy (eg, any biologic \\[ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin\\]) or advanced oral small molecule \\[ie, Janus kinase inhibitor\\]) for CD.\n3. CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:\n\n   * Ileorectal anastomosis (rectum \\\u003C 15 cm), or a proctocolectomy.\n   * Short bowel syndrome.\n   * All ostomies.\n   * Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that have not been appropriately treated.\n4. History or current diagnosis of ulcerative colitis (unless this diagnosis was made erroneously), indeterminate colitis, idiopathic colitis (ie, colitis not consistent with CD), microscopic colitis, or colonic mucosal dysplasia (excluding dysplasia in resected adenomas).\n5. Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).\n6. Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.\n7. Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).\n8. Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.\n9. Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.\n10. History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.\n11. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder, or any known or suspected contraindication to any of the study biologics according to local prescribing information).",{"count":324,"type":22},378,[165],"This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).",[28],"2026-05-28",{"date":284,"type":37},{"date":331,"type":37},"2025-02-01",{"date":333,"type":22},"2029-01",{"name":335,"class":44},"Alimentiv Inc.",39,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":187,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},"100615392","phase-4-efficacy-of-mirikizumab-to-achieve-transmural-healing-in-patients-with-crohns-disease-100615392","NCT07292012","Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease","Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD","EMINENT-CD","Inclusion Criteria:\n\n* Patients with CD\n* ≥ 18 to ≤ 75 years-old\n* Symptomatic CD according to PRO-2 (stool \\> 3 or abdominal pain score \\> 1)\n* Transmural inflammation on baseline MRI (C-score \\> 0.5 in at least one segment)\n\nExclusion Criteria:\n\n* Prior exposure to anti-p19 biological therapy\n* Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase \\[JAK\\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents\n* Exclude any previous use of p19 IL23s agents\n* Contra-indication to mirikizumab\n* Definitive ostomy\n* Colectomy with IPAA\n* Isolated or uncontrolled perianal lesions\n* Severe obstructive symptoms\n* Intra-abdominal abscess\n* Contra-indication to MRI\n* No health insurance\n* Pregnant or lactating women\n* Patients already included in biomedical research other than an observational study (e.g., registry, cohort)\n* Concomitant Clostridioides difficile infection\n* HIV infection\n* Patient under guardianship, curatorship or safeguard of justice",{"count":346,"type":22},75,[25],"Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease",[28],[351,352,353],"crohn's disease","transmural healing","mirikizumab","2026-05-21",{"date":356,"type":37},"2026-05-26",{"date":358,"type":37},"2026-05-11",{"date":360,"type":22},"2028-11",{"name":43,"class":44},6,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":45},"100626899","qualitative-exploration-of-key-symptoms-of-stricturing-crohns-disease-toward-the-development-of-a-clinical-assessment-score-100626899","NCT07441629","Qualitative Exploration of Key Symptoms of Stricturing Crohn's Disease: Toward the Development of a Clinical Assessment Score.","SYMCROHNS","Inclusion Criteria:\n\n* Adult patient (≥ 18 years old).\n* With a confirmed diagnosis of Crohn's disease.\n* Presenting a stricturing form of the disease (confirmed clinically, endoscopically, radiologically, or surgically).\n* Followed in a hospital department managing inflammatory bowel diseases (IBD).\n* Clinically stable at the time of the interview (not experiencing an acute episode requiring urgent hospitalization).\n* Able to understand and speak French, in order to participate in a qualitative interview.\n\nExclusion Criteria:\n\n* Current hospitalization for a severe Crohn's disease flare, acute intestinal obstruction, or any situation requiring urgent medical care.\n* Severe cognitive impairment, communication deficits, or acute psychiatric disorder preventing understanding of the interview or reliable expression of experiences.\n* Major uncontrolled medical comorbidity (e.g., active cancer under treatment, severe heart failure) making the interview inappropriate or likely to confound symptom interpretation.\n* Technical inability to participate in an interview (no access to the proposed modalities: unable to travel, no access to videoconference if a remote interview is required).\n* Pregnant women\n* Persons deprived of their liberty\n* Persons receiving psychiatric care\n* Persons admitted to a healthcare or social institution\n* Adults subject to a legal protection measure\n* Persons unable to express their consent",{"count":371,"type":22},15,"The goal of this qualitative study is to identify and better understand the symptoms of stricturing Crohn's disease in order to inform the development of more appropriate clinical evaluation scores. This study focuses on adult patients diagnosed with stricturing Crohn's disease who are followed in hospital gastroenterology departments.\n\nThe main questions it aims to answer are:\n\n* Which symptoms are perceived by patients as the most specific and significant features of stenosing Crohn's disease?\n* Which symptoms are perceived by patients as early warning signs of a stenosing flare?\n* How does stenosing Crohn's disease impact daily life, mental health, and quality of life, and what coping strategies do patients use to manage symptoms and limit their impact?\n\nParticipants will:\n\n* Take part in a one-hour individual semi-structured interview, conducted in person (at the hospital, at home, or in another agreed location) or by videoconference\n* Have the interview audio-recorded for transcription and qualitative analysis\n* Be offered the opportunity to review and validate the transcript and summary of their interview before final anonymized analysis",[28],"2026-05-18",{"date":376,"type":37},"2026-05-20",{"date":378,"type":22},"2026-05",{"date":380,"type":22},"2026-11",{"name":382,"class":44},"University Hospital, Grenoble",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":403,"leadSponsor":405,"locationsCount":179},"100637736","vr-therapies-for-ibd-100637736","NCT07590518","VR Therapies for IBD","AI-Enhanced Virtual Reality Cognitive Behavioral Therapy to Reduce Anxiety and Improve Quality of Life in Patients With Inflammatory Bowel Disease: A Multicenter Pilot and Feasibility Study","Inclusion Criteria:\n\n* Stated willingness to comply with all study procedures, VR therapy regimen, and availability for the duration of the study\n* Age of 18 years or older\n* Confirmed diagnosis of IBD with concurrent anxiety, defined as a GAD-7 score of ≥10\n* Ability to read and write in English (VR\u002FAI CBT program is currently only available in English)\n* Access to an internet-enabled device (android or iOS smartphone, or personal laptop or desktop computer) to complete surveys and has access to internet and email complete baseline and assessment surveys.\n\nExclusion Criteria:\n\n* Have a condition that interferes with the safe use of VR usage, such as history of seizures, facial injuries precluding headset placement, significant visual or hearing impairment that impacts ability to see the VR images or follow audio instructions\n* Have cognitive impairments that would affect protocol participation.\n* Currently engaged in psychotherapy (Patients who are taking medications for anxiety or have previously engaged in psychotherapy but are not currently in therapy will remain eligible).\n* Have had an IBD related surgery (including perianal surgery) within the past 6 months or anticipated in the next 6 months\n* Anticipated to change their IBD inflammatory treatment during the study period.",{"count":391,"type":22},76,[165],"Through a pilot randomized controlled trial (RCT), the aim is to test the clinical impact and feasibility of a AI-enhanced Virtual Reality (VR) Cognitive Behavioral therapy (CBT) program versus distraction VR among patients with inflammatory bowel disease (IBD) and anxiety. It is hypothesized that using VR\u002FAI CBT may reduce anxiety and IBD symptoms, leading to improved overall physical, psychological, and social functioning when compared to distraction VR.",[58,59,28,395],"Anxiety",[397,398],"Virtual Reality","Cognitive Behavioral Therapy","2026-05-12",{"date":401,"type":37},"2026-05-15",{"date":196,"type":22},{"date":404,"type":22},"2027-07",{"name":406,"class":44},"Brennan Spiegel",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":45},"100569160","water-preparation-in-crohns-diseases-imagery-100569160","NCT06690632","WAter Preparation in Crohn's Disease's Imagery","WAter Preparation for Magnetic Resonance Enterography in Crohn's Disease","WAM","Inclusion criteria:\n\n* Diagnosis of Crohn's Disease,\n* need for MRE (determined by patient's gastroenterologist)\n\nExclusion criteria:\n\n* \\\u003C 18 years old,\n* inability to obtain an informed consent,\n* patient under guardianship or curatorship, allergy to PEG,\n* contraindication to MRE (pregnancy, pace maker, claustrophobia in particular), - contraindication to phloroglucinol administration (phenylcetonuria),\n* contraindication to gadolinium administration (kidney failure with glomerular filtration rate \\\u003C 30\u002FmL\u002F1.73m², pregnancy, allergy).",{"count":416,"type":22},194,[165],"The goal of this clinical trial is to compare distension quality and patient experience of water and polyethylene glycol preparation as oral contrast media in Magnetic Resonance Enterography (MRE) in patients with Crohn's disease.\n\nThus, the main question it aims to answer is:\n\nIs water sufficient to interpret MRE from patients with Crohn's disease?\n\nResearchers will compare the standard protocol (polyethylene glycol) with water as bowel distension agent to see if it is possible to obtain a satisfying global distension of small bowel.\n\nParticipants will undergo the same procedures as standard care adding questionnaires and replacing water as the bowel distension agent for the MRE for patient randomized into the experimental group.",[28],[421,422,423,424,425],"Crohn","bowel distension","MRE","oral contrast media","tolerability","2026-05-07",{"date":428,"type":37},"2026-05-08",{"date":430,"type":37},"2025-01-29",{"date":432,"type":22},"2028-12-01",{"name":434,"class":44},"University Hospital, Toulouse",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":443,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":45},"100617129","combining-nutritional-therapy-and-anti-tnf-treatment-in-pediatric-patients-with-crohns-disease-100617129","NCT07314606","Combining Nutritional Therapy and Anti-TNFα Treatment in Pediatric Patients With Crohn's Disease","Open-Label Multicentre Randomized Dietary Intervention Study in Pediatric Crohn's Disease Patients Initiating Anti-TNF Therapy","DISPENSE-T","Inclusion Criteria:\n\n* Moderate-severe active luminal inflammatory (B1) pCD \\[wPCDAI \\> or = 40\\] ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* OR Strong suspicion of moderate-severe active luminal inflammatory (B1) pCD ileal +\u002F- colonic (L1, L2, L3), and in whom treating physician plans to start IFX\n* Within 12-months of diagnosis (when starting IFX treatment)\n* Naïve to a biologic therapy\n* For patients with established disease who flare up: no response to dietary intervention or steroids within 4 weeks of commencement of these therapies.\n* For newly diagnosed patients: no response to dietary intervention or steroids within 2 weeks of commencement of these therapies.\n* Evidence of active inflammation: FCP level \\> 250 µg\u002Fg and\u002F or CRP \\> 5 mg\u002FL or ESR \\> 20 mm\u002Fhr\n* BMI between the 5th and 95th percentiles, adjusted for age and sex\n* On steroids or EEN for less than 2 (or 4, for established disease) weeks\n* Able and willing to follow dietary recommendations\n* On stable dose of AZA or Methotrexate (MTX) at randomization\n* Willing to enroll in the CIDsCaNN Network study\n\nExclusion Criteria:\n\n* CDED, EEN, or steroids commenced more than 2 weeks prior to randomization\n* Antibiotic use in the last 2 months (except short course \\\u003C 1 week between 1-2 months) or laxative use within the past month (except for bowel prep for endoscopy pre commencement of anti-TNFα)\n* Pre-, pro-, synbiotic supplements in the last month (food containing these products, e.g. yogurt, allowed)\n* Strict vegetarians and vegans\n* High risk of malnutrition as assessed by the Paediatric Yorkhill Malnutrition Score (PYMS)\n* Other known GI disorders (except IBS), food intolerances or chronic diseases\n* Bowel surgery prior the randomization\n* Severe perianal disease (fistulizing or ulcerating), fibrostenotic (B2) or penetrating (B3) disease\n* Currently on prednisone\u002Fprednisolone for \\> 2 weeks\n* Pregnant or breastfeeding\n* Participating in another study\n* Inability to consent","9 Years","17 Years",{"count":446,"type":22},140,[165],"Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.",[28,143,450],"IBD - Inflammatory Bowel Disease",[452,453,215,454,455,456],"CDED","Exclusion Diet","Nutritional therapy","Pediatric","Diet Intervention","2026-04-27",{"date":311,"type":37},{"date":460,"type":37},"2026-04-22",{"date":462,"type":22},"2029-10-01",{"name":464,"class":44},"University of British Columbia",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":45},"100629189","study-of-concordance-between-inflammatory-activity-assessed-by-enteric-mri-with-and-without-intestinal-distension-product-in-patients-with-ileal-crohns-disease-100629189","NCT07471438","Study of Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.","CONFORT","Inclusion Criteria:\n\n* Patients with Crohn's disease according to European recommendations (ECCO) ≥ 18 years of age\n* With known or suspected ileal ± colonic involvement\n* Requiring reassessment of disease inflammatory activity according to the clinician\n* Able to give informed consent to participate in the research.\n* Affiliation with a Social Security scheme\n* Agreeing to undergo two MRIs in the same week\n\nExclusion Criteria:\n\n* Isolated colonic Crohn's disease\n* Resection \\> 1 m of small intestine\n* Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score)\n* Uncontrolled intra-abdominal abscess\n* Isolated anoperineal lesions\n* Prevention of postoperative endoscopic recurrence\n* Temporary or permanent stoma\n* Total colectomy\n* Contraindication to MRI\n* Pregnant or breastfeeding women\n* Protected adults (under guardianship, trusteeship, family authorization, future protection mandate, with representation relating to the person)",{"count":261,"type":22},[165],"Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can significantly impair patients' quality of life. Due to its transmural nature (affecting the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula), requiring intestinal resection in approximately half of patients during follow-up. The long-term goal for patients is to maintain a normal life, i.e., without symptoms and without intestinal destruction. To this end, short- and medium-term therapeutic goals have evolved in recent years. Clinical remission is not a sufficient goal, as it has not changed the natural history of the disease. The current goal is to achieve a combination of clinical remission and endoscopic mucosal healing, as this is associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection).\n\nTransmural healing assessed by MRI is also a promising goal associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Furthermore, it is associated with a lower risk of progression to intestinal destruction, unlike endoscopic remission. In this context, transmural healing could soon become the benchmark in terms of therapeutic objectives for Crohn's disease, particularly in the ileum. Although enteric MRI is better accepted than colonoscopy by patients with Crohn's disease, in the ACCEPT1 study, nearly half of patients (48.6%) reported the need to use an intestinal distension product (PEG, mannitol, etc.) as a significant obstacle to repeating entero-MRI, while more than a third complained of vomiting (33.7%) or severe diarrhea (35.0%) induced by these same products. Being able to do without the use of distension products would significantly improve the acceptability of entero-MRI.\n\nWe hypothesize that an enteric MRI without distension would lead to poorer ileal distension but would allow inflammatory activity scores to be assessed on MRI in a manner similar to an examination with distension, and thus would not impact the need for therapeutic intensification.",[28],[213,477],"MRI","2026-03-10",{"date":480,"type":37},"2026-03-13",{"date":482,"type":22},"2026-03",{"date":484,"type":22},"2026-09",{"name":251,"class":44},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":45},"100624747","virtual-histology-of-crohns-disease-ex-vivo-resected-anatomical-lesions-100624747","NCT07413653","Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions","VISCERAL","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of Crohn's disease and undergoing intestinal resection surgery at CHRU Nancy.\n* Patient has not objected to the reuse of personal data and biological samples for the purposes of this research.\n\nExclusion Criteria:\n\n\\- None",{"count":261,"type":22},"Crohn's disease is a chronic, incurable inflammatory bowel disease with an unpredictable course, characterized by alternating remission and inflammatory flares. Current follow-up strategies are poorly suited to early flare detection, leading to uncontrolled disease progression and complications. A major clinical challenge is distinguishing reversible inflammatory activity from irreversible intestinal fibrosis, as existing imaging techniques lack specificity. This study aims to perform comprehensive ex vivo multiparametric MRI, combined with biophysical measurements and histopathology, on resected intestinal specimens to precisely map inflammation and fibrosis and to validate in vivo MRI-derived biomarkers for personalized therapeutic decision-making.",[28],"2026-02-24",{"date":498,"type":37},"2026-02-25",{"date":500,"type":22},"2026-04-01",{"date":502,"type":22},"2028-04-01",{"name":504,"class":44},"Central Hospital, Nancy, France",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":45},"100626885","evaluation-of-muscle-strength-and-muscle-mass-in-patients-with-inflammatory-bowel-disease-100626885","NCT07441447","Evaluation of Muscle Strength and Muscle Mass in Patients With Inflammatory Bowel Disease","Evaluation of Sarcopenia in Patients With Inflammatory Bowel Disease","IBDSARC","Inclusion Criteria:\n\n* Age ≥18 years\n* Established diagnosis of inflammatory bowel disease (ICD-10: K50.\\* Crohn's disease, K51.\\* ulcerative colitis)\n* Ability to provide written informed consent\n* Ability to undergo ultrasonographic muscle assessment and handgrip strength testing\n* Availability of an abdominal computed tomography (CT) scan performed within the previous 6 months\n\nExclusion Criteria:\n\n* Known neuromuscular disorders or primary muscle diseases\n* Major orthopedic conditions affecting muscle strength assessment\n* Pregnancy\n* Abdominal wall defects or conditions interfering with ultrasound assessment\n* Incomplete clinical or imaging data\n* Any condition preventing reliable ultrasound or handgrip measurement",{"count":302,"type":22},"This prospective observational study aims to evaluate the validity of ultrasonographic muscle measurements in patients with inflammatory bowel disease (IBD). Sarcopenia is commonly assessed using computed tomography (CT)-based skeletal muscle area measurements at the L3 vertebral level, which are considered a gold standard method. However, CT is not always feasible due to radiation exposure and accessibility limitations.\n\nIn this study, muscle strength will be assessed using handgrip dynamometry, and muscle mass will be evaluated using ultrasonography of selected skeletal muscles. In patients with available recent abdominal CT imaging, L3 skeletal muscle area will be recorded. The primary objective is to compare ultrasonographic muscle measurements with CT-based assessments and to evaluate the agreement between these methods.\n\nThis study aims to determine whether ultrasonography can serve as a practical and reliable alternative tool for muscle mass evaluation in patients with IBD.",[28],[517,518,519,520,521],"Sarcopenia","Muscle Ultrasound","Computed Tomography","Handgrip Strength","L3 Skeletal Muscle","2026-02-23",{"date":524,"type":37},"2026-03-02",{"date":526,"type":37},"2025-11-10",{"date":528,"type":22},"2026-12",{"name":530,"class":44},"Sakarya University",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":4},"100624957","phase-1-safety-and-efficiency-of-the-universal-cnk-ut009-in-difficult-to-treat-inflammatory-bowel-disease-patients-100624957","NCT07416383","Safety and Efficiency of the Universal CNK-UT009 in Difficult-to-treat Inflammatory Bowel Disease Patients","An Exploratory Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetics of the Universal CNK-UT009 Cell Injection in Subjects With Difficult-to-treat Inflammatory Bowel Disease","Inclusion Criteria:\n\n* diagnosed moderate-to- severe IBD patients\n* defiened as difficult-to-treat(failed from at least two types of biologics or small molecular drugs, or refractory from at least twice of intestinal surgery)\n* with complete bone-marrow and organic function\n* no pregnant or planning to become pregnant\n* welling to paticipate\n\nExclusion Criteria:\n\n* patients with active infections or latent infections, malignant tumors, recent serious infections(within two weeks)\n* patients paticipated other clinical trials with four weeks\n* patients with drug combination other than low-dose glucocotiod\n* patients recieved abdominal surgery or live vaccine\n* patients with planned surgery in three months\n* unsuitable situations determined by researchers",{"count":139,"type":22},[281],"Inflammatory bowel disease patients who failed from at least two types of biologics or suffered refractory after at least twice surgery are defiened as difficult-to-treat IBD. It is reported a low five-year suvival rate around 15% of difficult-to-treat IBD patients. Cell therapy is a promising new strategy in auto-immune diseases beyond malignant cancers. Inbalanced immune microenvironment contribute to IBD and cell therapy should be a brighting selection of difficult-to-treat IBD. CNK-UT009 is an universal cellular immunotherapy targeted to auto-reactive T cells whose safety and effect were proved in patients with GVHD and type 1 diabetes mellius. Here, we conducted a single-arm open-label exploratory clinical study of CNK-UT cell therapy on difficult-to-treat IBD patients, mainly to explore the safety and define the maximum tolerated dose. Besides, the preliminary effect would also be evaluated.",[542,28,59],"Inflamatory Bowel Disease","2026-02-14",{"date":545,"type":37},"2026-02-18",{"date":500,"type":22},{"date":548,"type":22},"2031-12-31",{"name":550,"class":44},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":573},"100611808","switching-to-the-il-23-inhibitor-guselkumab-for-people-with-active-ibd-who-previously-used-ustekinumab-shift-ibd-100611808","NCT07245394","Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)","SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD","SHIFT-IBD","Inclusion Criteria:\n\n* Subjects of any gender aged ≥ 18.\n* Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%.\n* Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy.\n* For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab.\n* Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician.\n* For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%.\n* Ability and willingness to give written informed consent and comply with the requirements of this study protocol.\n* Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:\n\n  * For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment.\n  * For Ulcerative Colitis: Colonoscopy showing Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≥4, OR presence of erosions or ulcers in any segment.\n\nExclusion Criteria:\n\n* History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).\n* Subjects with formal contraindication to guselkumab per the drug label.\n* Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded.\n* Subjects with an ostomy or ileo-anal pouch.\n* Subjects with a history of bowel surgery within 6 months prior to Week 0.\n* Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0.\n* Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment.\n* Subjects on 1 or more concomitant biologics.\n* Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible.\n* Subjects with formal contraindication or unwilling to undergo lower endoscopy.\n* The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.",{"count":560,"type":22},200,"The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.\n\nPatients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year.\n\nGuselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care.\n\nResearchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy.\n\nThe goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.",[58,28,59,563],"IBD-unclassified (IBD-U)","2026-02-10",{"date":566,"type":37},"2026-02-12",{"date":568,"type":37},"2026-01-29",{"date":570,"type":22},"2028-11-01",{"name":572,"class":44},"TIDHI Innovation Inc.",9,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":587,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":45},"100584972","impact-of-exclusion-diet-in-addition-to-anti-tnf-therapy-in-crohns-disease-and-ulcerative-colitis-a-prospective-randomized-double-arm-open-label-study-100584972","NCT06896305","Impact of Exclusion Diet in Addition to Anti-TNF Therapy in Crohn's Disease and Ulcerative Colitis: a Prospective, Randomized, Double-arm, Open-label Study","Impact of Diet on the Effectiveness of Anti-TNF Therapy in Inflammatory Bowel Disease: a Prospective, Randomized, Double Arm, Open-label Study","IDEA-TNF","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent forparticipation in the study\n2. Males or Females, Adults aged 18 years or older\n3. Confirmed diagnosis of moderate-to-severe Crohn's disease orulcerative colitis\n4. Patients who are planned to start anti-TNF therapy\n5. Ability and willingness to comply with the Crohn's DiseaseExclusion Diet (CDED)\n\nExclusion Criteria:\n\n1. Patients with undetermined inflammatory bowel disease\n2. Patients with metabolic or gastrointestinal conditions that couldinterfere or are incompatible with the study intervention (e.i.celiac disease, diabetes etc)\n3. Patients with a body-mass index lower than 17 or greater than30\n4. Patients who previously underwent intestinal resectionirrespective of cause\n5. Patients currently on exclusive enteral nutrition (EEN)\n6. Patients who have previously used or are currently adhering toCDED\n7. Pregnant or breastfeeding women\n8. Patients with a history of severe allergic reactions orintolerance to any food recommended in CDED\n9. Patients with significant comorbidities that may interfere withthe study or pose a risk to the participant\n10. Inability or unwillingness to comply with study protocols orfollow-up schedules",{"count":583,"type":22},80,[165],"This clinical study protocol aims to prospectively compare the efficacy of standard therapy with anti-TNF agents combined with the Crohn's Disease Exclusion Diet (CDED) versus anti-TNF therapy alone in adult patients with active Crohn's disease or ulcerative colitis.\n\nThe study will involve patients starting therapy with anti-TNF agents due to active Crohn's disease or ulcerative colitis as per standard clinical practice and in accordance with European (ECCO) guidelines.\n\nOne group will receive standard medical therapy only, the other will additionally receive dietary advice on how to adhere on a specific exclusion diet, the CDED.\n\nBy prospectively evaluating the impact of this combined approach, the study seeks to provide evidence on whether CDED can improve response to treatment and therefore improve quality of life for patients with Crohn's disease and ulcerative colitis.",[59,28],[61,145,588,589,421],"Crohn's Disease Exclusion Diet","Ulcerative colitis","2026-01-20",{"date":592,"type":37},"2026-01-22",{"date":594,"type":37},"2025-05-22",{"date":596,"type":22},"2027-10-01",{"name":598,"class":44},"IRCCS Ospedale San Raffaele",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":621,"locationsCount":45},"100612827","phase-1-fluorescence-imaging-of-adalimumab-680lt-and-risankizumab-800cw-in-inflammatory-bowel-disease-100612827","NCT07258641","Fluorescence Imaging of Adalimumab-680LT and Risankizumab-800CW in Inflammatory Bowel Disease","Dual Wavelength Fluorescence Imaging Using Fluorescently Labelled Adalimumab and Risankizumab for Visualizing Drug Targeting in Inflammatory Bowel Diseases","VOYAGER","Inclusion Criteria:\n\nPatients eligible for inclusion meet all of the following criteria:\n\n* Established IBD diagnosis (UC or CD).\n* Active disease: clinically active disease of the bowel is defined as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \\> 60 µg\u002Fg\n* Patients must be eligible for adalimumab or risankizumab therapy.\n* Age of 18 years\n* Written informed consent\n* Clinical indication for an endoscopic procedure\n\nFor female subjects who are of childbearing potential, are premenopausal with intact reproductive organs, or are less than 2 years postmenopausal:\n\n• A negative pregnancy test (urine or blood test) must be available.\n\nExclusion Criteria:\n\nA female study patient who is pregnant or provides breastfeeding\n\n* A female study patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT and\u002For risankizumab 800CW administration\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent\n* Prior anti-IL23-specific therapy (IL23\u002FIL12 combination therapy is not an exclusion criteria)\n* Prior anti-TNFα therapy in the last 6 weeks before inclusion\n* Previous treatment with adalimumab and detectable anti-adalimumab antibody levels",{"count":114,"type":22},[281,86],"Inflammatory bowel diseases (IBD) are chronic relapsing inflammatory disorders of the gastrointestinal tract affecting 2.5 million patients in Europe alone. The majority of newly diagnosed patients are in adolescence or early adulthood and in the midst of their family life, career, and social development.\n\nIBD comes with significant morbidity and complex treatment strategies and is associated with a high social burden and medical costs. Besides other factors, the pathogenesis of IBD is attributed to proinflammatory cytokine tumor necrosis factor α (TNFα) and Interleukin 23 (IL-23). Adalimumab, a human monoclonal anti-TNF antibody, and risankizumab, a humanized monoclonal anti-IL-23 antibody, are used to treat patients with moderate to severely active IBD. However, IBD patients often only partially respond to such biological immunomodulating therapies, resulting in high primary nonresponse (30-60%) and loss of response over time (48-58%). The investigators are currently missing reliable tools for response prediction because the limitations of current technologies do not allow the visualization of the molecular phenotype or heterogeneity within patients. Therefore, patients are potentially exposed to a non-effective treatment and its potential side effects while clinical deterioration is ongoing. In addition, it remains completely unknown for most biologicals used for IBD therapy whether they reach their actual targets in the tissue and if a sufficient local concentration is present to achieve treatment response. To develop a predictive tool for assessment of therapeutic (non-)response to patients and gain insights into local drug concentrations in individual patients before initiating anti-TNF or anti-IL23 therapy, the University Medical Center Groningen (UMCG), fluorescently labeled adalimumab (adalimumab-680LT) and risankizumab (risankizumab-800CW) to visualize and quantify the labeled drugs in diseased tissue with dedicated optical fluorescence imaging systems. In previous studies, the investigators have proven that those tracers bind to TNFα\u002FIL23 in the mucosa after intravenous injection and that the investigators can investigate the drug distribution in vivo due to the colocalization of the fluorescently labeled compound. The aim of this follow-up study is to assess the feasibility of simultaneous dual wavelength imaging of adalimumab-680LT and risankizumab-800CW at baseline and evaluate target saturation after at least 14 weeks of adalimumab or risankizumab therapy. The investigators will also use in vivo and ex vivo fluorescence molecular imaging (FMI) to visualize tracer target cells and the patient's molecular phenotype for potential treatment response prediction in IBD patients in the future.\n\nThe investigators will determine the feasibility of dual wavelengths molecular fluorescence imaging using the GMPproduced near-infrared fluorescent tracers adalimumab-680LT and risankizumab-800CW for visualizing medicine distribution in and ex vivo IBD patients with dedicated fluorescence imaging systems.\n\nFurthermore, the investigators will evaluate TNF and IL23 target saturation after 14 weeks of adalimumab or risankizumab therapy and characterize the tissue microenvironment where the drug is abundant and identify potential drug target cells.",[59,28],[612,61,613,614],"Fluorescence Molecular Endoscopy","Risankizumab-800CW","Adalimumab-680LT","2026-01-12",{"date":617,"type":37},"2026-01-14",{"date":619,"type":22},"2026-01-15",{"date":502,"type":22},{"name":622,"class":44},"University Medical Center Groningen"]