[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohns-disease-cd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohns-disease-cd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,74,96,123,145,173,208,230,261,285,309],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645243","ultrasound-guided-versus-standard-margin-selection-in-ileocecal-resection-of-terminal-ileal-cd-100645243",false,"NCT07680283","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD","Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial","SMILE-CD","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum\u002Fileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery.\n* Scheduled to undergo primary ileocolic resection.\n\nExclusion Criteria:\n\n* Penetrating disease with abscess or complex fistula requiring complex resection.\n* Prior ileocolic resection.\n* Diagnosis of Crohn's colitis.\n* Pregnancy or inability to provide informed consent.\n* Stoma at or before randomization: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as \"not assessed for endoscopic recurrence (stoma)\" with reasons documented.\n* Contraindication to IOUS (as determined by the surgeon).","ALL","18 Years",{"count":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.",[27],"Crohn's Disease (CD)",[29,30,31,32,33,34],"Ultrasound","ileocecal resection","anastomosis","resection margin","ileocolic resection","Crohn's disease","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":21},"2026-07",{"date":43,"type":21},"2029-01",{"name":45,"class":46},"The Cleveland Clinic","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100644522","tailored-anti-inflammatory-american-diet-for-patients-with-crohns-disease-100644522","NCT07671872","Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease","Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease","Inclusion Criteria:\n\n* Documented diagnosis with Crohn's Disease from medical records.\n* Ages 16-75\n* Mild to moderately active CD disease, defined by one of the following criteria:\n\nCrohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin \\>150mg\u002Fdl. or radiologic findings of active ileal and\u002For colonic disease, or endoscopic findings showing active ileal and\u002For colonic disease within 4 weeks of baseline\n\n-On stable medications for their disease as or 3 months if medication is not listed\n\nExclusion Criteria:\n\n* Diagnosis of Ulcerative Colitis (UC).\n* Prior J pouch or diversion\n* Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks\n* Clostridium difficile or enteric infections in the last 4 weeks\n* Use of probiotics in the last 4 weeks\n* Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet\n* Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)\n* Pregnancy, breastfeeding or planning to become pregnant during study period\n* Use of Total Parenteral Nutrition at the time of screening and during the study period\n* Other significant or life-threatening co-morbidities\n* The need for antibiotic use during the study period\n* Adults unable to consent\n* Ages \\\u003C 16 and \\> 75 years old\n* Prisoners\n* Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection\n* Patients with concomitant Celiac disease","16 Years","75 Years",{"count":58,"type":21},122,[24],"The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.",[62,27,63],"Crohn's Disease, Active","Diet Interventions","NOT_YET_RECRUITING","2026-06-22",{"date":67,"type":39},"2026-06-26",{"date":69,"type":21},"2026-08",{"date":71,"type":21},"2030-08",{"name":73,"class":46},"University of Miami",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":47},"100640316","a-pilot-study-micro-and-nanoplastics-in-association-with-crohns-disease-100640316","NCT07630883","A Pilot Study: Micro and NanoPlastics in Association With Crohn's Disease","Integrated Multi-phase Investigation of Role of Micro and NanoPlastics in Association With Crohn's Disease: Targeting Microbiome, Immunity, and Barrier Dysfunction: A Pilot Study","Inclusion Criteria:\n\nCases:\n\n* Age 18-80 years\n* Confirmed diagnosis of Crohn's disease (for cases)\n* Ability to provide informed consent.\n\nControl:\n\n* Age 18-80 years old\n* No history of major large bowel resection\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\nCases:\n\n* Antibiotic\u002Fprobiotic use within 4 weeks\n* History of gastrointestinal malignancy\n* Presence of stoma\n* Currently Pregnant\n* Advanced terminal medical illness, e.g. terminal malignancies; end staged renal failure and liver failure\n\nControl:\n\n* Currently Pregnant\n* Advanced terminal medical illness, e.g. terminal malignancies; end staged renal failure and liver failure\n* Inability in giving consent","80 Years",{"count":83,"type":21},90,"OBSERVATIONAL","Micro and nanoplastics (MNPs) are environmental contaminants found in food and water. Recent evidence suggests these particles may be linked to intestinal inflammation and changes in gut bacteria, which are key features of Crohn's Disease (CD). This study aims to investigate if patients with Crohn's Disease have a reduced ability to clear these plastic particles and how this affects their immune system and intestinal health.",[27],"2026-06-02",{"date":89,"type":39},"2026-06-05",{"date":91,"type":21},"2026-06-15",{"date":93,"type":21},"2031-12-31",{"name":95,"class":46},"Mak Wing Yan",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":105,"studyType":84,"phases":4,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100611202","zymfentra-infliximab-dyyb-real-world-cohort-study-100611202","NCT07237516","Zymfentra (Infliximab-dyyb) REal World Cohort STudy","ZEST","Inclusion Criteria:\n\n\\- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months.\n\n3\\. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.\n\nThe following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU:\n\nA) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.\n\nAND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.\n\nAND\n\nC) One or more of the following providing objective evidence of inflammation:\n\nEndoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.\n\nRadiologic: Mucosal thickening and\u002For nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and\u002For nodularity) should not be sufficient to make a diagnosis of IBD.\n\nHistologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate\\*, fibrosis of muscularis propria\\*, noncaseating granuloma\\*.\n\n\\* CD\n\nIndividuals with IBD should be classified into one of three categories, based on most recent diagnosis:\n\nCrohn's disease (CD):\n\n1. Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.\n2. Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.\n3. Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (\\>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)\n4. The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).\n5. If there are fewer than 10 aphthoid ulcers in the cecum (and the rest of the colon appears normal) in a patient with small bowel disease then this should be called small bowel disease only. Similarly, if the colon is normal except for the presence of a fistula extending from inflamed small bowel, the patient should be said to have small bowel disease alone. If the cecum is involved with ulcers larger than aphthoid ulcers or ulcers that are deep or if the involvement has resulted in deformity of the cecum this would be considered to be colonic involvement.\n\nUlcerative Colitis (UC)\n\n1\\) Superficial inflammation and\u002For ulceration (involving only the mucosa and submucosa) of the colon which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (N.B. Relative rectal sparing is allowed for patients receiving topical rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).\n\n2\\) In patients with proctitis or left-sided ulcerative colitis there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.\n\n3\\) No inflammation of the small intestine (\"backwash ileitis\" is allowed - non-stricturing superficial inflammation of the terminal ileal mucosa associated with severe pancolitis which resolves following medical or surgical treatment of the colitis).\n\n4\\) No features of Crohn's disease listed above.\n\nInflammatory Bowel Disease Unclassified (IBDU):\n\n1. Confirmed IBD by A, B and C above.\n2. Physician unable to classify individual into either CD or UC based on above criteria and\u002For patient has features of both CD and UC with none of the feature's diagnostic of one or the other.\n\nExclusion Criteria:\n\n* 1\\.\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Inability to provide informed consent.\n2. Non-English speaking\n3. Patients presenting for a one-time consultation.",{"count":104,"type":21},200,"12 Months","The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.",[108,27,109,110],"Ulcerative Colitis (UC)","Indeterminate Colitis","Inflammatory Bowel Disease (IBD)",[112,101],"Zymfentra","2026-05-22",{"date":115,"type":39},"2026-05-26",{"date":117,"type":39},"2025-11-20",{"date":119,"type":21},"2028-11-03",{"name":121,"class":46},"University of North Carolina, Chapel Hill",9,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":47},"100639884","research-on-the-whole-process-of-ai-intelligent-management-system-for-the-diagnosis-and-treatment-of-inflammatory-bowel-diseases-100639884","NCT07590271","Research on the Whole Process of AI Intelligent Management System for the Diagnosis and Treatment of Inflammatory Bowel Diseases","Inclusion Criteria:\n\nInclusion criteria for the IBD group:\n\nPatients diagnosed with IBD (K50.00 to K51.919) within the specified time interval.\n\nInclusion criteria for the non-IBD group:\n\nPatients never diagnosed with IBD (K50.00 to K51.919) within the specified time interval.\n\nExclusion Criteria:\n\nPatients not within the specified time interval Deceased patients\n\nExclusion criteria for the non-IBD group:\n\nPatients not within the specified time interval Deceased patients Patients with fewer than 5 hospital visits",{"count":130,"type":21},4500,"Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated disorder requiring long-term management. Clinically, IBD may involve recurrent intestinal inflammation, ulcer formation, and complications such as strictures and fistulas. The etiology of IBD is associated with immune dysregulation, gut microbiome imbalance, and genetic susceptibility. Its clinical manifestations are heterogeneous; early symptoms such as abdominal pain, diarrhea, weight loss, hematochezia, or anemia often resemble gastroenteritis, irritable bowel syndrome, or infectious enterocolitis, leading to misdiagnosis and delayed diagnosis. According to international studies, the interval between initial symptom onset and confirmed diagnosis can range from several months to years, during which untreated disease progression increases the risks of hospitalization, surgery, bowel strictures, and fistulizing complications, resulting in significant impacts on patient quality of life.\n\nThis study adopts a retrospective design, analyzing our hospital's electronic medical record data from 2023 to 2025.The objective is to evaluate the performance and feasibility of an artificial intelligence (AI) model-developed and incorporating natural language processing (NLP) and phenotypic recognition algorithms-in supporting early identification and diagnosis of IBD. The model has been validated in multiple European healthcare systems and is capable of recognizing high-risk phenotypic clusters from large-scale structured and unstructured medical data. This study represents the first application of this AI technology in the Taiwanese IBD population. All data processing will occur within a de-identified and secure computing environment to ensure data privacy and information security.\n\nThe study will compare AI-generated diagnostic suggestions derived from medical records with actual clinical diagnoses to assess consistency and accuracy. The model's performance across different clinical characteristics, disease severity levels, and stages of illness will also be examined. In addition, statistical metrics such as precision and recall will be used to generate PRC curves for determining the optimal diagnostic threshold. The outcomes of this study are expected to validate the potential of AI technology in facilitating early recognition, accelerating diagnosis, and supporting clinical decision-making for IBD. The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.\n\nObjective 1：To retrospectively analyze the clinical characteristics and diagnostic pathways of patients with IBD (CD\u002FUC).\n\nObjective 2：To evaluate the performance of the AI model in identifying and providing diagnostic suggestions for high-risk IBD cases.\n\nObjective 3：To compare the accuracy and consistency between AI-generated diagnostic suggestions and actual clinical diagnoses.",[133,27,108,134,135],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Artificial Intelligence (AI)","Natural Language Processing (NLP)","2026-05-11",{"date":138,"type":39},"2026-05-15",{"date":140,"type":21},"2026-06-01",{"date":142,"type":21},"2027-12-31",{"name":144,"class":46},"Taichung Veterans General Hospital",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":172},"100422322","phase-3-a-study-of-vedolizumab-in-children-and-teenagers-with-moderate-to-severe-crohns-disease-cd-100422322","NCT04779320","A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)","A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy","Main Inclusion Criteria:\n\n1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).\n2. The participants weigh ≥10 kg at the time of screening and enrollment into the study.\n3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \\>30 and an simple endoscopic score for Crohn's Disease (SES-CD) \\>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.\n4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate \\[MTX\\]), and\u002For tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.\n5. Participants with extensive colitis or pancolitis of \\>8 years' duration or left-sided colitis of \\>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.\n6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.\n\nMain Exclusion Criteria:\n\n1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.\n2. Participants with active cerebral\u002Fmeningeal disease, signs\u002Fsymptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.\n3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \\[COVID-19\\]) within 30 days prior to first dose of study drug.\n4. The participants has received any live vaccinations within 30 days prior to first dose.\n5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.\n6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \\>3 small intestine resections.\n7. Participants with a current diagnosis of indeterminate colitis.\n8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.\n9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:\n\n   * Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR\n   * A TB skin test reaction ≥5 mm.\n10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \\[HBsAg\\]-negative and hepatitis B antibody-positive) may, however, be included.\n\n    Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.\n11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \\[HCVAb\\] and HCV RNA).\n\n    Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \\[defined as no evidence of HCV RNA at least 12 weeks before baseline\\]).\n12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \\[HIV\\] infection, organ transplantation).\n13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.\n14. Participants with positive stool studies for ova and\u002For parasites or stool culture at screening visit.\n15. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.\n\nOther inclusion\u002Fexclusion criteria may apply.","2 Years","17 Years",{"count":155,"type":21},120,[157],"PHASE3","Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab.\n\nThe main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation.\n\nParticipants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.",[27],[161],"Drug Therapy","2026-04-30",{"date":164,"type":39},"2026-05-05",{"date":166,"type":39},"2022-02-10",{"date":168,"type":21},"2027-09-13",{"name":170,"class":171},"Takeda","INDUSTRY",96,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":47},"100633250","ketogenic-and-carnivore-lion-diets-for-inflammatory-bowel-disease-and-rheumatoid-arthritis-100633250","NCT07524244","Ketogenic and Carnivore (Lion) Diets for Inflammatory Bowel Disease and Rheumatoid Arthritis","Effectiveness and Efficacy of a Ketogenic or Carnivore (Lion) Diet for Quality Life and Symptom Burden in Individuals With Symptomatic Inflammatory Bowel Disease or Rheumatoid Arthritis: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Diagnosed with medically verifiable IBD or medically verifiable RA\n* Current personal residence in the continental U.S.\n* Willingness and ability to follow dietary protocols\n\nExclusion Criteria:\n\n* Inability to provide consent\n* Individuals with Type 1 or Type II Diabetes on prescription medications including insulin\n* Outside of the age or BMI criteria\n* No medically definitive or verifiable diagnosis of IBD or RA\n* History of strictures or fistula (IBD)\n* History of blood transfusion in the previous 6 months\n* Pregnancy\n* 6 months Postpartum\n* Breastfeeding\n* On other medications outside of FDA approved medications\n* Current initiation of disease modifying or biologic medication within the past 2 months\n* Unable to complete, for any reason, the initial 3-week run-in period prior to the beginning of the formal study intervention\n* Non-English Speaking\n* Organ failure of any kind including heart, liver and kidney failure or disease\n* History of malignancy within the last year prior to enrollment\n* Red meat allergy, alpha-gal allergy","64 Years",{"count":182,"type":21},160,[24],"This study is a randomized controlled clinical trial evaluating whether two therapeutic dietary approaches - a ketogenic diet and a carnivore (lion) diet - can improve quality of life, reduce symptoms, and influence measures of disease activity in adults with inflammatory bowel disease \\[ulcerative colitis and Crohn's disease\\] (IBD) or rheumatoid arthritis (RA).\n\nParticipants will be randomized into one of three groups: 1) Ketogenic Diet, 2) Carnivore (Lion) Diet or 3) Wait-List Control.\n\nParticipants randomized to a dietary group (ketogenic diet or carnivore diet) will be provided guidance on their specific dietary therapy and answer questions about their symptoms and quality of life at different intervals over a 24 week period. Participants will also complete laboratory testing at different intervals to assess for changes in nutritional status, cardiometabolic health and markers of immune activation and inflammation.\n\nParticipants initially placed on the wait-list group will be asked similar questions about their symptoms and quality of life and complete the same laboratory testing as participants in a dietary group. Participants on the wait list will then be compared to participants following a specific dietary pattern to assess for any differences between the 2 groups. After 12 weeks, participants on the wait list will be randomized to a dietary group (ketogenic diet or carnivore diet) and followed in a similar fashion for an additional 12 week period.",[186,27,108],"Rheumatoid Arthritis (RA)",[188,189,190,191,192,193,194,195,196,197,198],"ketogenic diet","carnivore diet","rheumatoid arthritis","inflammatory bowel disease","ulcerative colitis","crohn's disease","autoimmunity","randomized controlled trial","dietary intervention","lion diet","nutritional therapy","2026-04-13",{"date":201,"type":39},"2026-04-16",{"date":203,"type":39},"2026-02-17",{"date":205,"type":21},"2027-09",{"name":207,"class":46},"Fuller Research Foundation",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":47},"100633542","an-observational-multicenter-study-to-evaluate-the-effectiveness-of-guselkumab-for-the-treatment-of-participants-with-crohns-disease-after-surgical-resection-100633542","NCT07528040","An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection","POST-CD","Inclusion Criteria:\n\n* Patients≥ 18，\n* Have a documented diagnosis of moderate to severe CD\n* Have undergone an ileocolonic surgical resection\n\nExclusion Criteria:\n\n* Has complications of CD, such as short bowel syndrome Currently has or is suspected to have an abscess\n* Active infection\n* Currently has a malignancy or has a history of malignancy within 5 years",{"count":216,"type":21},88,"The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.",[27],[220],"IBD","2026-04-07",{"date":223,"type":39},"2026-04-14",{"date":225,"type":21},"2026-04-15",{"date":227,"type":21},"2029-05-31",{"name":229,"class":46},"Shanghai 10th People's Hospital",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":238,"sex":17,"minAge":239,"maxAge":18,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":260},"100633118","biologics-and-paediatric-enteral-nutrition-in-crohns-disease-study-100633118","NCT07522528","Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study","Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study (BIOPIC-Kids): Combining Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Children With Active Crohn's Disease","BIOPIC-Kids","Inclusion Criteria:\n\n* Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg\u002Fkg and who have a clinical indication to initiate standard of care induction treatment with TNFα inhibitors (infliximab or adalimumab).\n* Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg\u002Fkg and who are due to initiate standard of care induction treatment with EEN therapy alongside TNFα inhibitors (infliximab or adalimumab) or standard of care induction treatment with EEN therapy without TNFα inhibitors (infliximab or adalimumab)\n\nExclusion Criteria:\n\n* Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are unable to provide consent on behalf of their child).\n* Presence of stoma or of short bowel syndrome.\n* Patients currently receiving oral or intravenous steroids at a dosage \\>20mg\u002Fday prednisolone or \\>9mg\u002Fday budesonide.\n* Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks.\n* CD with a major fistulising or symptomatic fibrotic stricturing phenotype.\n* Patients with comorbid anorexia nervosa.\n* Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition.\n* Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C.\n* Patients with untreated tuberculosis (latent or active).\n* Current enrolment in other studies of an investigational product or dietary intervention.\n* Food allergies, which do not permit participation in the study (e.g., cow's milk allergy).\n* Pregnant and\u002For breastfeeding individuals.",true,"6 Years",{"count":83,"type":21},[24],"Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 55-60%. The liquid-only diet also has a better safety and effectiveness profile than traditional treatments like steroids. However, gut inflammation often returns not long after the normal diet is re-introduced, and it is difficult for patients to stick to as their sole source of nutrition for 6-8 weeks.\n\nThe BIOPIC-Kids study aims to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment and maintenance of remission with biologics in children and young adults with CD. To achieve this, children and young adults (aged 6-18 years) with active CD commencing biologics as standard of care treatment will be randomly allocated to follow their normal diet OR replace varying amounts of their normal diet with specialised milkshakes for 6 weeks. Participants not wanting to be randomised can choose the group of their preference. Patients starting a liquid-only diet OR biologics alongside a liquid-only diet as standard of care treatment will also be recruited to compare different treatment outcomes.",[27],[245,246,247,248,249,250,251,252],"Crohn's Disease","Partial Enteral Nutrition","Exclusive Enteral Nutrition","Biologic Therapy","Infliximab","Adalimumab","Combination Therapy","Paediatric","2026-04-03",{"date":199,"type":39},{"date":256,"type":39},"2026-03-27",{"date":71,"type":21},{"name":259,"class":46},"University of Glasgow",6,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":269,"minAge":18,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":282,"leadSponsor":284,"locationsCount":47},"100618921","comparing-over-the-counter-pain-medicines-for-discomfort-in-crohns-disease-avid-cd-100618921","NCT07337902","Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)","Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial","AVID-CD","Inclusion Criteria:\n\n* Ages 18-44 years\n* Assigned female at birth\n* Crohn's Disease (CD) diagnosis\n* In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) \\\u003C150 without use of corticosteroids\n* Self-reported primary dysmenorrhea\n* Regular menstrual cycles occurring every 23-35 days\n* Using an appropriate contraceptive method or abstinence\n\nExclusion Criteria:\n\n* Any of the following conditions: endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids\u002Fpolyps, chronic pelvic inflammatory disease, a history of pelvic surgery including hysterectomy, any other pathological pelvic conditions, or current pregnancy\n* Plans to become pregnant during the study period\n* Use of an oral contraceptive for less than 3 months, on an unstable oral contraceptive dose within the last 3 months, switched from one oral contraceptive to another within the last 3 months or intend to do so during the course of the trial\n* Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptive\n* Known hypersensitivity or contraindication to ibuprofen or acetaminophen\n* Inability to complete REDCap questionnaires (including confusion despite training and\u002For lack of smart phone and\u002For computer access).\n* Not able to speak and read English language.","FEMALE","44 Years",{"count":272,"type":21},24,[24],"The purpose of this pilot study is to prepare for a larger study that will compare the effectiveness and safety of two common pain medications, ibuprofen and acetaminophen, to help treat period cramps in women with Crohn's disease. The goal of this study is to identify any challenges in running a larger study. The investigators will track how many people sign up for the study, how well participants follow the study plan, how many people stay in the study, and whether they are able to complete all the study activities, such as taking the medication, submitting samples, and filling out surveys.\n\nDuring the study, participants will undergo a screening visit that includes a blood draw, physical exam, pregnancy test, stool testing, and complete surveys about Crohn's disease and menstrual cycles. Once this visit is complete, the rest of the study will occur at home.\n\nParticipants will be assigned to take either ibuprofen or acetaminophen to help treat period cramps for four menstrual cycles in a row. Participants will take ibuprofen for two cycles and acetaminophen for two cycles. Participants will know which medication is being taken at any given time, but the order in which they take the medications will be randomly assigned.\n\nBefore each menstrual cycle, participants will submit a stool sample and fill out a short (\\\u003C1 minute) electronic survey. When participants develop period cramps, they will take the assigned medication for three days and fill out short (\\\u003C1 minute) electronic surveys about their cramps. After participants finish taking the medication for three days, they will submit another stool sample and fill out two more short (\\\u003C1 minute) electronic surveys. After have completing this process for four menstrual cycles, a remote interview with a researcher to give feedback on the study will be conducted.",[27,276],"Dysmenorrhea Primary",[245],"2026-03-18",{"date":280,"type":39},"2026-03-23",{"date":278,"type":39},{"date":283,"type":21},"2028-07",{"name":121,"class":46},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":47},"100616756","early-phase-1-universal-car-t-cell-injection-targeting-cd19bcma-in-patients-with-inflammatory-bowel-disease-100616756","NCT07309744","Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Inflammatory Bowel Disease","Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* The subject voluntarily participates in this trial and signs the informed consent form.\n* Aged ≥ 18 years and ≤ 70 years, regardless of gender.\n* Organ function and laboratory tests:\n\n  1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's syndrome).\n  2. Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml\u002Fmin.\n  3. Complete blood count: Neutrophil count ≥ 1 × 10⁹\u002FL; Hemoglobin ≥ 60 g\u002FL; Platelet count ≥ 20 × 10⁹\u002FL; Lymphocyte count \\> 0.3 × 10⁹\u002FL.\n  4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, or Prothrombin Time (PT) ≤ 1.5 × ULN.\n  5. Oxygen saturation (SpO₂) ≥ 92% in room air at rest.\n  6. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n* Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.\n* Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion until 12 months after RD06-05 infusion. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion until 12 months after RD06-05 infusion, and must not donate semen or sperm during the entire trial period.\n\nInclusion Criteria for Patients with Ulcerative Colitis (UC)\n\n* Diagnosis of ulcerative colitis confirmed by clinical and endoscopic evidence at least 3 months before screening, and verified by histopathological report. If no pathological report is available, additional biopsies may be performed during the screening period to obtain specimens, which will be sent to a local pathological laboratory for diagnostic confirmation.\n* Moderate to severe active ulcerative colitis, defined as a Mayo score between 6 and 12 points with an endoscopic subscore ≥ 2 points (endoscopic examination performed within 14 days before screening).\n* Confirmed that the extent of ulcerative colitis lesions involves above the rectosigmoid junction (approximately ≥ 15 cm from the anal verge).\n* Patients with extensive colitis or pancolitis with a disease duration of more than 8 years, or left-sided colitis with a disease duration of more than 12 years, must have written evidence of having undergone a colonoscopy within 12 months before the first screening visit (may be performed during the screening period or within 14 days before screening).\n* Subjects with a family history of colorectal cancer, personal history of high risk for colorectal cancer, age \\> 50 years, or other known risk factors must have completed colorectal cancer-related screening (including but not limited to colonoscopic biopsy, imaging, biomarkers, etc., which may be performed during the screening period).\n* Previous proven inadequate response, loss of response, or intolerance to at least one of the following drugs:\n\nGlucocorticoids:\n\nAfter at least one cycle of induction therapy (equivalent to oral prednisone 30 mg daily for 2 weeks or intravenous administration for 1 week), signs and symptoms of persistent active disease still exist; OR Previous failure of at least two attempts to reduce glucocorticoid dosage to below oral prednisone 10 mg\u002Fday or equivalent dose; OR Previous history of glucocorticoid intolerance (including but not limited to: Cushing's syndrome, osteopenia or osteoporosis, hyperglycemia, insomnia, infection, etc.).\n\nImmunomodulators:\n\nAfter previous treatment with oral azathioprine (≥ 1.5 mg\u002Fkg) or 6-mercaptopurine (≥ 0.75 mg\u002Fkg) for at least 8 weeks, signs and symptoms of persistent active disease still exist; OR Previous history of intolerance to at least one immunomodulator (including but not limited to: nausea, vomiting, abdominal pain, pancreatitis, abnormal liver function tests, lymphopenia, TPMT gene mutation, infection, etc.).\n\n* Patients with previous inadequate response, loss of efficacy, or intolerance to at least two drugs of different mechanism classes among biological therapy (such as anti-TNF antibodies, anti-IL antibodies, or anti-integrin antibodies) or Janus kinase (JAK) inhibitor therapy (such as upadacitinib) for ulcerative colitis. The aforementioned drugs must be domestically approved for the treatment of ulcerative colitis. Investigators must be able to provide relevant records of sufficient clinical treatment with the drug. Patients must meet any of the following criteria:\n\nInadequate efficacy: Despite induction therapy with the approved induction dose as specified in the drug instruction manual, the patient still shows signs and symptoms of persistent active disease; OR Loss of efficacy: On the basis of previous benefit, recurrence of signs and symptoms of active disease occurs during treatment with the approved maintenance dose as specified in the drug instruction manual (even if the drug is discontinued voluntarily after obtaining clinical benefit, it is not considered as biological therapy failure or intolerance to ulcerative colitis treatment); OR Intolerance: Previous history of intolerance to biological agents or JAK inhibitors approved for ulcerative colitis, including but not limited to infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, upadacitinib, or others (including but not limited to infusion-related events, demyelination, congestive heart failure, or any drug-related adverse event leading to dose reduction or discontinuation).\n\n* The following drugs are allowed to be used in the study under stable dosage:\n\nOral 5-aminosalicylic acid (5-ASA) treatment: The prescribed dosage has been used stably for at least 2 weeks before the screening colonoscopy; Oral glucocorticoid treatment (prednisone ≤ 20 mg\u002Fday or equivalent dose, or extended-release budesonide tablets 9 mg\u002Fday): The prescribed dosage has been used stably for at least 2 weeks before the screening colonoscopy.\n\n* Having the condition to discontinue other therapeutic drugs for UC (except the above-mentioned allowed concomitant drugs) before pretreatment. For specific drugs, please refer to the \"Section 7.14 Prohibited Concomitant Treatments\" in the protocol and the corresponding drug washout period regulations.\n* Willing and able to complete the scheduled study assessments, including but not limited to endoscopic examinations.\n\nInclusion Criteria for Patients with Crohn's Disease (CD)\n\n* The subject must be diagnosed with Crohn's disease at least 3 months before enrollment, and the diagnosis must be confirmed by clinical, endoscopic, and histopathological criteria. If no pathological report is available, the investigator may obtain specimens through additional biopsies during the screening period and send them to a local pathological laboratory for diagnostic confirmation.\n* The subject must be a patient with moderate to severe active Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 points during the screening period, and meet any of the following conditions:\n\nElevated C-reactive protein (CRP) level during the screening period (based on the upper limit of the reference range of the laboratory of each study center); OR Colonoscopy within 4 months before screening shows at least 3 non-anastomotic ulcers (each with a diameter \\> 0.5 cm) or at least 10 aphthous ulcers (involving a continuous intestinal segment ≥ 10 cm), consistent with the characteristics of Crohn's disease; OR Computed Tomography Enterography (CTE), Magnetic Resonance Enterography (MRE), Contrast-Enhanced Small Bowel Radiography, or Capsule Endoscopy within 4 months before screening shows Crohn's disease-related ulcers (patients with only aphthous ulcers, fixed strictures, or small bowel strictures with pre-stenotic dilatation should not be enrolled).\n\n* Subjects with a family history of colorectal cancer, personal history of high risk for colorectal cancer, age \\> 50 years, or other known high-risk factors must complete the latest colorectal cancer monitoring (including but not limited to colonoscopy and endoscopic biopsy, imaging, tumor biomarkers, etc.).\n* The subject has inadequate efficacy, loss of efficacy, or poor tolerance to at least one of the following drugs:\n\nGlucocorticoids:\n\nGlucocorticoid-refractory disease: Refers to subjects who still have signs and\u002For symptoms of active Crohn's disease after receiving oral prednisone (or equivalent drug) at a daily dose of ≥ 30 mg or budesonide at a daily dose of ≥ 9 mg for at least 4 weeks; OR Glucocorticoid-dependent disease: Refers to (1) inability to reduce the dose to prednisone equivalent dose \\\u003C 10 mg\u002Fday or budesonide \\\u003C 3 mg\u002Fday within 3 months after starting glucocorticoid use; or (2) recurrence within 3 months after completing a course of glucocorticoid treatment; OR Glucocorticoid intolerance: Refers to adverse reactions that lead to drug discontinuation when the subject uses glucocorticoids, including but not limited to Cushing's syndrome, osteopenia\u002Fosteoporosis, hyperglycemia, neuropsychiatric adverse reactions, etc.\n\nImmunomodulators:\n\nPersistent signs and\u002For symptoms of active disease still exist after using any of the following drugs for at least 3 months:\n\n1. Oral azathioprine (AZA) at a daily dose of ≥ 1.5 mg\u002Fkg, or 6-mercaptopurine (6-MP) at a daily dose of ≥ 0.75 mg\u002Fkg, or methotrexate (MTX) at 25 mg per week (intramuscular injection or subcutaneous injection); OR\n2. Oral AZA or 6-MP within the therapeutic range determined by thiopurine metabolite detection; OR\n3. Combined use of thiopurine and allopurinol, and within the therapeutic range determined by thiopurine metabolite detection; OR Intolerance to at least one immunomodulator: Adverse reactions leading to drug discontinuation when using any immunomodulator, including but not limited to nausea\u002Fvomiting, abdominal pain, pancreatitis, abnormal liver function, lymphopenia.\n\n   * Subject with biological therapy failure: Refers to subjects with inadequate efficacy, loss of efficacy, or poor tolerance to at least two biological agents of different mechanisms that have been approved for the treatment of Crohn's disease (such as anti-TNF antibodies, anti-IL antibodies, or anti-integrin antibodies). Investigators must be able to provide sufficient medication history records during the induction period and\u002For maintenance period. The subject must meet one of the following criteria:\n\nInadequate efficacy: Refers to persistent signs and\u002For symptoms of active disease after induction therapy with the induction dose specified in the product instruction manual; OR Loss of efficacy: Refers to the recurrence of signs and\u002For symptoms of active disease after obtaining clinical improvement during treatment with the approved maintenance dose; OR Poor tolerance: Refers to adverse reactions that lead to dose reduction or discontinuation when the subject uses domestically or approved biological agents (including but not limited to infusion-related events, demyelination, congestive heart failure, etc.).\n\n* Subjects are allowed to use the following drugs concomitantly at a stable dose during the study:\n\nOral 5-aminosalicylic acid (5-ASA) treatment: The dose has been stable for at least 2 weeks before the screening colonoscopy; Oral glucocorticoid treatment (prednisone ≤ 20 mg\u002Fday or equivalent dose, or budesonide ≤ 9 mg\u002Fday): The dose has been stable for at least 2 weeks before the screening colonoscopy; Antibiotics specifically used for the treatment of Crohn's disease: If used continuously, the dose has been stable for at least 2 weeks before the screening colonoscopy; Probiotics: Such as Saccharomyces boulardii, etc., with a stable dose for at least 2 weeks before the screening colonoscopy; Antidiarrheals: Such as loperamide, compound diphenoxylate with atropine, etc., used to control chronic diarrhea.\n\n* Having the condition to discontinue other therapeutic drugs for CD (except the above-mentioned allowed concomitant drugs) before pretreatment. For specific drugs, please refer to the \"Section 7.14 Prohibited Concomitant Treatments\" in the protocol and the corresponding drug washout period regulations.\n* Willing and able to complete the planned study assessments, including endoscopic examinations and daily diary records.\n\nExclusion Criteria:\n\n* Presence of other coexisting autoimmune diseases that may significantly interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months and is not expected to interfere with study assessments, enrollment may be permitted after confirmation by the investigator and the sponsor's medical monitor (or their designee).\n\nSubjects with the following cardiac diseases will be excluded:\n\nHistory of heart failure classified as New York Heart Association (NYHA) Class III or IV.\n\nHistory of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other severe cardiac diseases within 12 months before enrollment.\n\nHistory of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as traumatic brain injury, disturbance of consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhage.\n\nHistory of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.\n\nPrimary immunodeficiency. Presence of uncontrolled infection; simple urinary tract infections and upper respiratory tract infections are permitted as judged by the investigator and the sponsor's medical monitor (or their designee).\n\nKnown history of infection with human immunodeficiency virus (HIV), hepatitis C virus, or syphilis.\n\nActive or latent hepatitis B virus infection. Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies at screening.\n\nHistory of recurrent tuberculosis or known presence of recurrent tuberculosis. Subjects with a history of previous chimeric antigen receptor T-cell (CAR-T) therapy or any other genetically modified immune cell therapy will be excluded.\n\nAdministration of live-attenuated vaccines within 4 weeks before enrollment. History of allergy to any component of the cell therapy product. History of hypersensitivity to tacrolimus, or previous occurrence of ≥ Grade 3 tacrolimus-related toxicity (including but not limited to neurological, gastrointestinal, hepatic, renal, or hematological toxicity), especially subjects requiring hospitalization, will be excluded. Other cases may be considered eligible after confirmation by the investigator and the sponsor's medical monitor (or their designee).\n\nParticipation in another clinical trial within 30 days before screening. Pregnant or lactating subjects, as well as subjects of childbearing potential who cannot use effective contraceptive measures.\n\nConcomitant diseases requiring systemic treatment with therapeutic doses of glucocorticoids (except glucocorticoid treatment for adrenal insufficiency).\n\nPositive results for Clostridioides difficile (C. difficile) toxin or other intestinal pathogens detected within 30 days before colonoscopy screening or at screening. For subjects diagnosed with cytomegalovirus-associated colitis, adequate treatment must be completed and symptoms must be fully resolved for at least 3 months before the screening endoscopy.\n\nPatients with a history of lymphoma, leukemia, or any malignant tumor within the past 10 years are not allowed to enroll.\n\nThe following conditions do not exclude enrollment:\n\nBasal cell carcinoma or squamous cell carcinoma of the skin that has been adequately treated with no evidence of metastasis within 1 year; Carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence within 3 years before baseline.\n\nPatients with significant, uncontrolled neuropsychiatric diseases, patients judged by the investigator to be at risk of suicide, or patients with a history of alcohol dependence and\u002For substance abuse currently or within the past year are not allowed to enroll.\n\nPresence of unstable or uncontrolled diseases, including but not limited to cerebrocardiovascular, respiratory, gastrointestinal (excluding ulcerative colitis), hepatic, renal, endocrine, hematological, or neurological diseases, which may affect patient safety during the study or interfere with efficacy assessment.\n\nPatients with a known allergy to any component of the investigational drug are not allowed to enroll.\n\nAny other conditions deemed unsuitable for participation in the study by the investigator.","70 Years",{"count":294,"type":21},30,[296],"EARLY_PHASE1","This is an open-label, Phase I, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). The enrolled population consists of patients with refractory moderate-to-severe inflammatory bowel disease who have received multiple lines of biologic therapy.\n\nTwo cohorts are established in the study to explore the optimal biological dose (OBD) for each indication:\n\nCohort 1: Ulcerative Colitis Cohort Cohort 2: Crohn's Disease Cohort The study presets 3 dose groups, which are 3, 6, and 10×10⁶ CAR+T cells\u002Fkg respectively. The initial dose group is 3×10⁶ CAR+T cells\u002Fkg (Dose Group 1), and dose de-escalation or escalation may be conducted based on the assessment of the Safety Review Committee (SRC).\n\nIt is expected that no more than 9 patients will be enrolled in each cohort.",[299,27],"Moderate-to-severe Ulcerative Colitis","2025-12-15",{"date":302,"type":39},"2025-12-30",{"date":304,"type":21},"2025-12-20",{"date":306,"type":21},"2028-12-30",{"name":308,"class":46},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":335},"100599015","phase-2-clinical-study-of-the-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-bcd-261-in-subjects-with-moderate-to-severe-active-crohns-disease-100599015","NCT07078994","Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease","A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease","COMANDOR","Inclusion Criteria:\n\n1. The diagnosis of Crohn's disease involving the terminal ileum or colon (types L1-L3 according to the Montreal classification), established ≥3 months prior to signing the informed consent form and confirmed by endoscopic findings.\n2. Moderate to severe active Crohn's disease, manifested by the following signs:\n\n(1) Crohn's Disease Activity Index (CDAI) ≥220 and ≤450 points.\n\n(2) Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 points or ≥4 points for the disease form with isolated involvement of the ileum (according to central independent review).\n\n3\\. Inadequate response to therapy according to the investigator's assessment, manifested by at least one of the following signs:\n\n1. Persistent symptoms of disease activity despite treatment with at least one course of glucocorticoids including prednisolone at a dose of ≥40 mg\u002Fday or equivalent or budesonide ≥9 mg\u002Fday or equivalent for at least 2 weeks with oral administration (at least 1 week with intravenous administration at a dose equivalent to oral prednisolone ≥40 mg\u002Fday).\n2. Steroid dependence manifested by an increase in disease activity after initial improvement, with a decrease in the dose of glucocorticoids below the dose equivalent to 10 mg of oral prednisolone per day, within 3 months from the beginning of treatment, or a relapse of the disease within 3 months after the end of glucocorticoid use.\n3. Persistent symptoms of disease activity despite treatment with at least one course of immunosuppressants (azathioprine at a dose of ≥2.0 mg\u002Fkg and\u002For 6-mercaptopurine at a dose of ≥1.0 mg\u002Fkg and\u002For methotrexate at a dose of ≥15.0 mg\u002Fweek) for ≥12 weeks, or in response to another treatment regimen with these drugs according to a regional standard of care.\n4. Primary lack of response to therapy with TNFa inhibitors and\u002For anti-integrins, and\u002For IL-12\u002F23 inhibitors, and\u002For targeted immunosuppressors (upadacitinib), defined as the persistence of symptoms of disease activity despite at least one course of induction of remission according to a treatment scheme approved by the regional standard.\n5. Loss of response to therapy with TNFa inhibitors and\u002For anti-integrins, and\u002For IL-12\u002F23 inhibitors, and\u002For targeted immunosuppressors (upadacitinib), defined as the appearance of symptoms of disease activity after initial improvement as a result of treatment with at least one course of induction of remission and at least one course of maintenance of remission according to a treatment scheme approved by the regional standard.\n6. A history of intolerance to glucocorticoid therapy and\u002For immunosuppressors (azathioprine, 6-mercaptopurine, methotrexate) and\u002For biologic therapies (TNFα inhibitors, anti-integrins, IL-12\u002F23 inhibitors) and\u002For targeted immunosuppressors (upadacitinib), as determined by the treating physician.\n\n4\\. Maintaining a stable dose of concomitant medications for ≥2 weeks prior to signing the ICF and in the screening period for glucocorticoids and for ≥4 weeks prior to signing the\n\nICF and in the screening period for immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate).\n\nExclusion Criteria:\n\n1. A history of or current at the time of signing the ICF ulcerative colitis, unspecified colitis, ischemic colitis, radiation colitis, microscopic colitis, complicated form of diverticular disease.\n2. A history of primary sclerosing cholangitis.\n3. Presence of active intra-abdominal or perianal abscess at the time of signing the ICF.\n4. Presence of an endoscopically obstructed stricture\u002Fstenosis of the intestine at the time of signing the ICF.\n5. A history of toxic megacolon, intestinal obstruction, intestinal perforation (except for those caused by injury or appendicitis).\n6. A history of dysplasia in any part of the gastrointestinal tract at the time of signing the ICF.\n7. Previous resections of the small intestine with a total length of resected segments \\>100 cm and\u002For resection of \\>2 segments of the large intestine (ascending colon (including the cecum), transverse colon, descending colon (including the sigmoid colon), rectum)3.\n8. Presence of intestinal stoma or artificial rectum or the need for them.\n9. Failure of ≥3 classes of biologics\u002Ftargeted immunosuppressors (according to INN) with different mechanisms of action (TNFa inhibitors, anti-integrins, IL-12\u002F23 inhibitors, upadacitinib) or ≥4 biologics\u002Ftargeted immunosuppressants (according to INN), regardless of the mechanism of actio\n\n   * Use of any of the indicated therapies within the specified time frame or need for therapy with these drugs during the study period:\n\n     1. Use of TNFa inhibitors within 8 weeks prior to signing the ICF or during the screening period.\n     2. Use of anti-integrins or IL-12\u002F23 inhibitors within 12 weeks before signing the ICF or during the screening period.\n     3. Use of Janus kinase inhibitors (upadacitinib) within 2 weeks prior to signing the ICF or during the screening period.\n     4. Use of oral glucocorticoids at a dose equivalent to prednisone \\>20 mg\u002Fday or budesonide \\>9 mg\u002Fday or rectal administration of glucocorticoids at any dose within 2 weeks prior to signing the ICF or during the screening period or parenteral administration of glucocorticoids at any dose within 4 weeks prior to signing the ICF or during the screening period.\n     5. Use of immunosuppressants not included in the approved therapy (tacrolimus, cyclosporine, mycophenolate mofetil, rapamycin, leflunomide, penicillamine, etc.) within 4 weeks before signing the ICF or during the screening period.\n     6. Long-term regular use of non-steroidal anti-inflammatory drugs (≥3 times a week for ≥6 weeks) for 2 weeks prior to signing the ICF.\n     7. Use of any other investigational drugs in other clinical trials at the time of signing the ICF or less than 8 weeks or 5 half-lives (whichever is longer) before the date of signing the ICF or during screening.",{"count":318,"type":21},204,[320],"PHASE2","The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients with moderate to severe active Crohn's Disease. The study will be conducted in a population of male and female subjects ≥18 years and ≤75 years with moderate to severe active Crohn's Disease and an inadequate response to prior treatment with glucocorticoids, immunosuppressants, or biologics\u002Ftargeted immunosuppressants.",[27],[324,34,325,326],"biologics","monoclonal antibodies","TL1A","2025-09-16",{"date":329,"type":39},"2025-09-17",{"date":331,"type":39},"2025-08-14",{"date":43,"type":21},{"name":334,"class":171},"Biocad",20]