[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibd---inflammatory-bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibd---inflammatory-bowel-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,45,79,109,136,163,188,212,239,259],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100605665","pre-packaged-low-residue-diet-assisting-bowel-preparation-in-patients-with-inflammatory-bowel-disease-100605665",false,"NCT07165470","Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease","Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease：A National Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age: Adult patients between 18 and 75 years old;\n* Diagnosis of IBD according to the 2023 Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;\n* Voluntary participation in this clinical trial and provision of signed informed consent.\n\nExclusion Criteria:\n\n* Patients with acute IBD, severe conditions, combined with major bleeding, suspected toxic megacolon, CD with severe intestinal stricture, gastrointestinal obstruction, or other conditions deemed unsuitable for colonoscopy by the physician;\n* Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction;\n* History of previous colorectal surgical resection or use of medications that may affect intestinal motility within one week (e.g., antidepressants, sedatives, calcium channel blockers);\n* History of stroke, spinal cord injury, or psychiatric disorders that impair compliance with bowel preparation and colonoscopy;\n* Allergy to any component of the administered drugs or meal replacements;\n* Pregnant or lactating women, and other individuals considered unsuitable for bowel preparation and colonoscopy by the physician.","ALL","18 Years","75 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objectives of this study are as follows:\n\n1.To evaluate the efficacy of Maifu Changqing® Complete Nutritional Formula Powder in bowel preparation for colonoscopy among inflammatory bowel disease (IBD) patients;2.To enhance nutritional status and procedural comfort during bowel preparation in the IBD population.",[27,28],"Colonoscopy: Bowel Preparation","IBD - Inflammatory Bowel Disease",[30,31,28],"bowel preparation","colonoscopy","RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-14","ACTUAL",{"date":38,"type":36},"2025-09-01",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"Changhai Hospital","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"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":56,"type":21},140,[24],"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.",[60,61,28],"Crohn Disease (CD)","IBD (Inflammatory Bowel Disease)",[63,64,65,66,67,68],"CDED","Exclusion Diet","Infliximab","Nutritional therapy","Pediatric","Diet Intervention","2026-04-27",{"date":71,"type":36},"2026-05-01",{"date":73,"type":36},"2026-04-22",{"date":75,"type":21},"2029-10-01",{"name":77,"class":43},"University of British Columbia",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},"100622606","exploring-fecal-calprotectin-levels-maternal-and-infant-microbiota-infant-health-nutrition-and-adverse-pregnancy-outcomes-with-patient-with-inflammatory-bowel-disease-100622606","NCT07385807","Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease","Exploring the Gut Microbiota and Dietary Contributors to Elevated Infant Fecal Calprotectin In Patients With Inflammatory Bowel Disease: A Pilot Study (CALINA-IBD)","CALINA-IBD","Inclusion Criteria:\n\nAll patients\n\n* Pregnant individuals ≥19 years recruited during their first, second or early third trimester.\n* Own or have regular access to a smartphone compatible with the study smartphone application RXFood.\n\nIBD patients\n\n● A documented IBD diagnosis (CD or UC) with active or quiescent disease.\n\nNon-IBD controls ● Absence of IBD.\n\nExclusion Criteria:\n\nAll patients\n\n* Inability to provide consent\n* Previous gastrointestinal cancer or bowel surgery\n* Renal disease\n* HIV\u002FAIDS or other serious infection\n* Fetal chromosomal or structural abnormalities\n* Other immune-mediated diseases (e.g., multiple sclerosis, rheumatoid arthritis, primary sclerosing cholangitis)\n* Prebiotic, probiotic or postbiotic supplements in the month prior to first sample collection\n* Gastroenteritis during or 1 month before the first sample collection\n* Travel outside of Canada and the United States in the month prior to first sample collection\n\nIBD patients\n\n● Pregnant individuals with active perianal or extra-intestinal disease in IBD",true,"FEMALE","19 Years",{"count":91,"type":21},80,"OBSERVATIONAL","The goal of this prospective longitudinal cohort study is to examine how the human microbiome of pregnant women-including bacteria and fungi in the gastrointestinal tract, vaginal canal, skin, and breastmilk-may influence infant gut inflammation, measured by fecal calprotectin (FCP) levels, and to identify factors that could inform dietary interventions to improve infant health outcomes. Specifically, the study aims to determine which maternal gut microbiome characteristics and dietary patterns during pregnancy are associated with elevated FCP levels in infants, and which infant gut microbiota compositions and dietary factors are linked to high FCP levels. Researchers will compare microbiome signatures and dietary factors in pregnant women and their infants with active or inactive IBD, as well as non-IBD controls, to identify microbial patterns that may predict infant gut inflammation. Participants will provide fecal samples at all study timepoints, one vaginal swab during the third trimester of pregnancy, and optional breastmilk and breast skin swab samples. They will also complete 3-day diet recalls using a smartphone app and participate in a longitudinal follow-up over 12 months after birth to monitor dietary patterns, microbiome profiles, and gut inflammation in both mother and infant.",[61,95,28,96],"IBD","Pregnancy",[96,95,98,99,85,100],"Crohn's Disease","Ulcerative Colitis","Inflammatory Bowel Disease","2026-04-03",{"date":103,"type":36},"2026-04-06",{"date":105,"type":36},"2026-03-20",{"date":107,"type":21},"2028-02-01",{"name":77,"class":43},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":78},"100627086","guselkumab-vs-ustekinumab-in-stricturing-crohns-disease-100627086","NCT07444060","Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease","Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study","Inclusion Criteria:\n\n* Confirmed patients with moderate-to-severe Crohn's disease (CD), aged 18 to 80 years, receiving treatment with Guselkumab or Ustekinumab.\n* Presence of obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks, with confirmed postprandial abdominal pain attributable to strictures, with the exclusion of: ① mild to moderate pain (postprandial abdominal pain or abdominal pain exacerbated by diet, ameliorated with abdominal bowel sounds) without nausea, vomiting or abdominal colic; ② dietary restrictions unrelated to abdominal pain.\n* Evidence of definite luminal strictures caused by the disease itself confirmed by radiographic imaging or endoscopic examination, i.e., meeting any of the following criteria:\n\n  1. Enteric computed tomography (CT): Presence of intestinal strictures on enteric CT, with two of the three following findings at the stricture site compared with the adjacent proximal bowel: ① a \\>50% reduction in luminal diameter; ② a \\>25% increase in bowel wall thickness; ③ pre-stenotic dilation \\>2.5 cm.\n  2. Endoscopic examination: Intestinal strictures that are impassable to the endoscope.\n\nExclusion Criteria:\n\n* Patients with severe disease requiring emergency surgery or endoscopic therapeutic intervention, or those judged by the attending clinician to need a switch of medication or elective surgery within 2 months, such as those with acute severe intestinal obstruction, perforation, intra-abdominal abscess, intra-abdominal adhesion, and other conditions leading to obstruction, hemorrhage, infection, etc.\n* Intestinal obstruction, intra-abdominal abscess, isolated intestinal stricture and other lesions secondary to surgery.\n* Patients who have received definitive therapeutic interventions for strictures within the past 6 months, such as endoscopic balloon dilation, stricture incision, intestinal stricture plasty, surgical\u002Fmanual anal dilatation, etc.\n* Severe patients who remain unable to take oral intake despite enteral nutrition (EN) administration for more than 2 months.\n* Patients who have used Guselkumab (GUS), Ustekinumab (UST) or other IL-23 antagonists within the past 12 months; or those with contraindications to GUS\u002FUST, or intolerance to the study medications due to other causes (e.g., allergy to IL-23 antagonists).\n* Patients with contraindications to small intestinal computed tomography (CT), such as contrast media allergy.\n* Patients with relative contraindications to biological agents, such as active tuberculosis with a positive chest X-ray for pulmonary tuberculosis or a strongly positive tuberculin skin test; a history of myocardial infarction, heart failure or demyelinating neurological diseases within the past 5 years.\n* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.\n* Patients complicated with intestinal dysplasia (e.g., diagnosed with short bowel syndrome), colostomy or colorectal neoplasms.\n* Patients complicated with active massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, as well as intractable vomiting and severe malabsorption syndrome.\n* Pregnant or lactating patients.\n* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.\n* Patients with psychiatric disorders, or those with insufficient educational level to fully understand the study content or unable to cooperate with the completion of the study.","80 Years",{"count":118,"type":21},100,"This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.",[121,122,28],"CD - Crohn's Disease","Stricture; Bowel",[124,125,126],"Stricturing Crohn's Disease","Guselkumab","Ustekinumab","2026-02-25",{"date":129,"type":36},"2026-03-02",{"date":131,"type":21},"2026-03-01",{"date":133,"type":21},"2029-12-31",{"name":135,"class":43},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":54,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":78},"100607943","evaluation-of-the-smart-ibd-app-in-pediatric-ibd-100607943","NCT07195123","Evaluation of the SMART IBD App in Pediatric IBD","Evaluation of the SMART IBD App Digital Therapeutic Tool for Pediatric Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Confirmed diagnosis of IBD (Crohn's Disease, ulcerative colitis, or indeterminate colitis)\n* Prescribed at least one daily or weekly medication for treatment of IBD\n* \\\u003C86% adherence to prescribed medication\n* Access to internet via Wi-Fi or data plan and access to smartphone\n* English fluency for patient and caregiver\n\nExclusion Criteria:\n\n* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review\n* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review","13 Years",{"count":145,"type":21},70,[24],"The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.",[149,61,28,150,151,60,95],"Inflammatory Bowel Disease (IBD)","Ulcerative Colitis (UC)","Indeterminate Colitis",[95,100,99,151,153],"Crohns Disease","2025-11-19",{"date":156,"type":36},"2025-11-21",{"date":158,"type":36},"2025-10-23",{"date":160,"type":21},"2027-08-31",{"name":162,"class":43},"Children's Hospital Medical Center, Cincinnati",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":78},"100610644","trial-comparing-multiport-robotic-and-laparoscopic-surgery-for-elective-colorectal-resections-in-ibd-patients-acro-ibd-100610644","NCT07230262","Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients (ACRO-IBD)","A Controlled Randomized Trial Comparing Multiport RObotic and Laparoscopic Surgery for Elective Colorectal Resections in IBD Patients","ACRO-IBD","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. Diagnosed with IBD and eligible for elective minimally invasive colorectal surgery, including:\n\n   1.4 Ileocecal\u002Fileocolic resections 1.5 Segmental colectomies 1.6 Total colectomy 1.7 Proctocolectomy 1.8 Proctectomy\n4. Procedures involving primary anastomosis or temporary or permanent stoma creation\n5. Suitable for minimally invasive surgery\n\nExclusion Criteria:\n\n1. Non IBD patients\n2. Urgent surgery (\\\u003C24 hours from hospital admission)\n3. Not suitable for minimally invasive surgery\n4. Ileoanal pouch construction",{"count":172,"type":21},110,[24],"The aim of this study is to better understand whether robotic surgery leads to better outcomes than laparoscopy in terms of complications, recovery and quality of life.",[28],[177,178],"Patients with inflammatory bowel disease (IBD)","Colorectal surgery in IBD patients","2025-11-14",{"date":181,"type":36},"2025-11-17",{"date":183,"type":36},"2025-10-01",{"date":185,"type":21},"2028-12-01",{"name":187,"class":43},"Universitaire Ziekenhuizen KU Leuven",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":87,"sex":16,"minAge":17,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100602180","a-pharmacokinetic-pharmacodynamic-modeling-and-simulation-study-of-subcutaneous-infliximab-in-patients-with-inflammatory-bowel-disease-100602180","NCT07120152","A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Patients with Crohns disease with a score on the Crohn's disease activity index between 220 and 450.\n* Patients with active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only)\n\nExclusion Criteria:\n\n* Patients who have previously received a biological agent for the treatment of CD and UC and\u002For a tumor necrosis factor-alpha (TNFa)-inhibitor for the treatment of other diseases.\n* Patients who have allergies to any of the excipients of infliximab or any other murine and\u002For human proteins or patients with a hypersensitivity to immunoglobulin products.\n* Patients who have a current or past history of infection with HIV, hepatitis B or C (carriers of hepatitis B and C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled).\n* Patients who have acute infections requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of the study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug.\n* Patient who have an indeterminate result for interferon-y release assay (IGRA) or latent tuberculosis (TB) at Screening. For part 2, if IGRA result is indeterminate at the Screening, one retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.","55 Years",{"count":196,"type":21},439,"A subcutaneous formulation of infliximab CT-P13 (Remsima, Celltrion) has been approved for clinical use in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) after demonstration of pharmacokinetic (PK) non-inferiority compared to intravenous CT-P13. The added value of the subcutaneous formulation of CT-P13 has been recognized by IBD physician expert, patients and nurses. However, further investigation is needed to select the right patients and timing for switching to the new subcutaneous formulation. Before investing resources into the design and execution of a prospective clinical trial to address these remaining clinical questions and concerns, an in silica simulation study using a population pharmacokinetic-pharmacodynamic (popPK-PD) model of CT-P13 would be highly informative. While popPK models of subcutaneous infliximab CT-P13 have been developed for both IBD and RA, a popPK-PD model is still awaited. The development of a popPK-PD model would allow us to bridge infliximab exposure and response, and address clinically relevant questions by focussing on therapeutic outcomes.",[28,199],"RA - Rheumatoid Arthritis",[201,202,95,100,65],"pharmacokinetic-pharmacodynamic model","Model","NOT_YET_RECRUITING","2025-08-26",{"date":206,"type":36},"2025-09-03",{"date":38,"type":21},{"date":209,"type":21},"2027-03-01",{"name":211,"class":43},"Erwin Dreesen",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":44},"100602316","ex-vivo-confocal-imaging-and-proteomic-profiling-to-determine-treatment-response-in-children-with-ibd-100602316","NCT07121920","Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD","A Prospective Study Evaluating Ex-vivo Confocal Imaging of Fluorescent Tagged Monoclonal Antibodies and Proteomic Profiles of Biopsied Tissue to Predict Therapeutic Response Among Children and Adolescents With Inflammatory Bowel Disease","Inclusion Criteria:\n\n\\- Patients must fall into one of the below categories: (i) with suspected and\u002For established diagnosis of IBD (ii) patients with IBD on treatment with biologics irrespective of treatment response (iii) patients who are diagnosed with IBD but treatment naïve to biologics. (iv) patients diagnosed with IBS and previous endoscopy results were negative for IBD who will serve as controls\n\nExclusion Criteria:\n\n* Those with previous allergy to fluorescein\n* Pregnant and breastfeeding patients","2 Years","21 Years",{"count":222,"type":21},40,[24],"This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of\u002Fstrongly correlated to clinical response\u002Foutcomes observed.\n\nThe key questions under investigation are:\n\nAim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy).\n\nAim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD.\n\nAim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.",[61,95,28],[227,228,95,229,230],"Ex-vivo","Inflammatory bowel disease","CLE","Confocal laser endomicroscopy","2025-08-12",{"date":233,"type":36},"2025-08-14",{"date":38,"type":21},{"date":236,"type":21},"2028-07-01",{"name":238,"class":43},"Cook Children's Health Care System",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":78},"100577791","long-term-treatment-with-ustekinumab-in-patients-with-crohns-disease-and-ulcerative-colitis-a-cohort-study-100577791","NCT06802887","Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Cohort Study","Long-term Treatment With Ustekinumab in Patients With Crohn's Disease and Ulcerative Colitis: a Monocentric, Observational, Retrospective\u002FProspective Cohort Study","Inclusion Criteria:\n\n* Signed informed consent\n* Male and female patients, aged ≥18 years\n* Patients who began treatment with Ustekinumab according to the indications for marketing authorization, following clinical practice and the information contained in the product's technical data sheet, during the period from February 2019 to March 2021.\n\nExclusion Criteria:\n\n* None",{"count":247,"type":21},12,"Monocentric observational retrospective\u002Fprospective pharmacological study. Clinical records of patients with Ulcerative Colitis and Crohn's Disease who started therapy with Ustekinumab between February 2019 and March 2021 at the IBD Unit will be reviewed. The main objective is to evaluate the overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab between February 2019 and March 2021, as well as the impact of treatment on the natural history of the disease. The study involves the collection of follow-up data for a maximum period of 24 months from the start of therapy. For patients who began therapy with Ustekinumab from February 2019 up to 24 months before the start of enrollment, data collection will be conducted retrospectively. For patients who have undergone therapy with Ustekinumab within 24 months prior to the start of enrollment, and up to March 2021, data will be collected both retrospectively and prospectively.",[28],"2025-01-26",{"date":252,"type":36},"2025-01-31",{"date":254,"type":36},"2021-07-18",{"date":256,"type":21},"2025-12",{"name":258,"class":43},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":266,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":78},"100571554","monitoring-of-patients-with-inflammatory-bowel-diseases-the-experience-of-the-reference-center-of-the-emilia-romagna-100571554","NCT06721767","Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna","The Multidisciplinary and Multiparametric Monitoring of Patients With Inflammatory Bowel Diseases: the Experience of the Reference Center of the Emilia-Romagna","Inclusion Criteria:\n\n* Signed informed consent\n* Age \\> 14 years\n* Diagnosis of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Microscopic Colitis) according to ECCO guidelines\n* Having undergone at least one outpatient visit and\u002For hospitalization at the Regional Reference Center for IBD \"Massimo Campieri\"\n* Acquisition of written informed consent from the patient and\u002For both parents\u002Flegal guardian\n\nExclusion Criteria:\n\n\\- None","14 Years",{"count":268,"type":21},10000,"The study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. Specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.",[28],"2024-12-03",{"date":273,"type":36},"2024-12-06",{"date":275,"type":36},"2024-01-08",{"date":277,"type":21},"2034-07-01",{"name":258,"class":43}]