[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibd":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,52,80,101,124,154,187,214,238,262,290,318,343,364,403,432,457,486,515,541,562,586,606,629,653],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100626308","partial-enteral-nutrition-to-prevent-weight-loss-and-sarcopenia-in-ibd-patients-at-nutritional-risk---simba-100626308",false,"NCT07433946","Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA","Partial Enteral Nutrition Effects on Weight Loss and Sarcopenia in Patients With IBD at Risk of Caloric-Protein Malnutrition - SIMBA","SIMBA","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)\n* Ability to provide informed consent\n* Women of childbearing potential must use effective contraception\n\nExclusion Criteria:\n\n* Following an exclusion diet (CDED)\n* Current hospitalization\n* Pregnancy\n* Requirement for a low-protein diet","ALL","18 Years","65 Years",{"count":21,"type":22},146,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.\n\nIBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk.\n\nParticipants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal\u002Fday) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA\u002FBIVA, vitamin B12\u002FD, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score).\n\nThe study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.",[28,29,30,31],"Ulcerative Colitis (Disorder)","Crohn Disease","Malnutrition or Risk of Malnutrition","IBD",[31,33,34,35,36,37,38],"Malnutrition","Sarcopenia","ONS","enteral nutrition","weight loss","clinical nutrition","RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-25","ACTUAL",{"date":45,"type":43},"2026-03-09",{"date":47,"type":22},"2027-01-31",{"name":49,"class":50},"Lionhealth Srl Società Benefit","INDUSTRY",4,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":63,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100580977","impact-of-ibd-activity-on-frailty-in-patients-over-60-years-100580977","NCT06844318","Impact of IBD Activity on Frailty in Patients Over 60 Years","Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years","FRAGIL","Inclusion Criteria:\n\n* Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.\n* Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and\u002For biologics) due to clinical activity based on PRO2 scales (UC: PRO \\>4; CD: PRO2 \\>14) and\u002For biological activity (fecal calprotectin ≥500 mg\u002Fkg, C-reactive protein ≥10 mg\u002FL).\n* Signed informed consent for inclusion.\n\nExclusion Criteria:\n\n* Lack or withdrawal of informed consent.\n* Unclassified\u002Findeterminate colitis.\n* Change in medical treatment solely due to adverse events.\n* Initiation of treatment only with salicylates and\u002For topical steroids for disease activity.\n* Treatment intensification to manage disease activity.\n* Patients with an ostomy.\n* Comorbidities with a life expectancy of less than one year.","60 Years",{"count":62,"type":22},153,"1 Year","OBSERVATIONAL","The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.\n\nThe main questions it aims to answer are:\n\n1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease?\n2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.",[31],[68],"eldearly","2026-05-06",{"date":71,"type":43},"2026-05-07",{"date":73,"type":43},"2025-04-14",{"date":75,"type":22},"2027-05",{"name":77,"class":78},"Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa","OTHER",34,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":5},"100492945","immunological-characteristics-of-preclinical-ibd-100492945","NCT05698745","Immunological Characteristics of Preclinical IBD","Prospective Study of the Natural History, Immunological and Genetic Characteristics of Preclinical Inflammatory Bowel Disease","Inclusion criteria\n\nPatients from cohort A will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* New diagnosis of IBD during a CRC screening colonoscopy, based on the criteria from the European Crohn's and Colitis Organization (33, 34).\n* Presence of a chronic inflammatory infiltrate and histological diagnosis compatible with IBD.\n* The patient must be asymptomatic at diagnosis and without previous symptoms suggestive of IBD.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nPatients from cohort B will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* Recent diagnosis of IBD, with \\\u003C3 months from symptoms onset.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nPatients from cohort C will be included if they fulfill all the following inclusion criteria:\n\n* Male or female ≥18 years of age at baseline.\n* No endoscopic signs of IBD after a complete ileo-colonoscopy within the CRC screening program.\n* Time interval between the index colonoscopy and the baseline visit up to 3 months.\n\nExclusion criteria\n\nPatients from cohort A will be excluded if they fulfill any the following exclusion criteria:\n\n* Identification of any enteropathogen in the stool culture.\n* Isolated findings of acute inflammatory infiltrate without signs of chronicity.\n* Previous or current diagnosis of microscopic colitis.\n* Alteration in biomarkers in blood or stool will not constitute an exclusion criterion.\n\nPatients from cohort B will be excluded if they fulfill any the following exclusion criteria:\n\n\\- Previous use of immunomodulators or biologics for any condition.\n\nPatients from cohort C will be excluded if they fulfill any the following exclusion criteria:\n\n* Any gastrointestinal symptoms at baseline.\n* Previous use of immunomodulators or biologics for any condition.",true,{"count":89,"type":22},450,"The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).",[29,92,31],"Ulcerative Colitis","2026-04-10",{"date":95,"type":43},"2026-04-15",{"date":97,"type":43},"2024-06-01",{"date":99,"type":22},"2038-07-01",{"name":77,"class":78},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100613797","a-randomised-paired-design-study-of-texture-and-colour-enhancement-imaging-txi-versus-high-definition-white-light-endoscopy-100613797","NCT07271264","A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy","A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy for Dysplasia Detection in IBD Surveillance.","Inclusion Criteria:\n\n* Patients \\>16 with inflammatory bowel disease undergoing surveillance colonoscopy.\n* Patients with Crohn's (L2\u002FL3 Montreal classification) with \\>50% colonic involvement OR\n* Patients with ulcerative colitis with Extensive or left sided disease (E3 or E2 Montreal classification) for at least 8 years or a diagnosis of Primary sclerosing cholangitis concomitant with IBD.\n\nExclusion Criteria:\n\n* Disease duration \\\u003C8 years unless a diagnosis of PSC\n* Incomplete colonoscopy\n* BBPS \\\u003C6 or \\\u003C2 in any segment\n* MES ≥2 or any variable of the SES-CD is ≥2 or any stenosis for \\>10cm segment (above the rectum)\n* Previous colorectal resection\n* Thrombocytopaenia (platelet count \\\u003C50) or Coagulopathy precluding biopsy\n* Anticoagulation that has not been held appropriately prior to the procedure (must be held at least the morning of the procedure).\n* Pregnancy\n* Unable or unwilling to consent to study participation","16 Years",{"count":110,"type":22},219,[25],"Texture and Colour Enhancement Imaging (TXI) improves texture, brightness, and colour in white-light endoscopy to highlight subtle tissue differences. Now available through the EVIS X1 system, early evidence suggests potential value in IBD. Studies show that TXI may help predict ulcerative colitis relapse and performs comparably to dye chromoendoscopy in detecting lesions, though no randomised data exist for dysplasia detection in IBD surveillance. We therefore propose a randomised paired study comparing TXI with high-definition white-light endoscopy for dysplasia detection in IBD surveillance.",[31],"2026-04-07",{"date":116,"type":43},"2026-04-13",{"date":118,"type":43},"2025-12-08",{"date":120,"type":22},"2029-03-30",{"name":122,"class":78},"London North West Healthcare NHS Trust",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":87,"sex":132,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"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","FEMALE","19 Years",{"count":135,"type":22},80,"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.",[138,31,139,140],"IBD (Inflammatory Bowel Disease)","IBD - Inflammatory Bowel Disease","Pregnancy",[140,31,142,92,130,143],"Crohn's Disease","Inflammatory Bowel Disease","2026-04-03",{"date":146,"type":43},"2026-04-06",{"date":148,"type":43},"2026-03-20",{"date":150,"type":22},"2028-02-01",{"name":152,"class":78},"University of British Columbia",2,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":87,"sex":17,"minAge":18,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":123},"100616049","phase-2-impact-of-the-gut-microbiota-on-host-cells-energy-metabolism-in-health-and-in-inflammatory-bowel-disease-100616049","NCT07300553","Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease","ENERGISED","Inclusion Criteria:\n\nHealthy volunteer\n\n1. Age ≥ 18 years and \\\u003C 50 years\n2. 17 kg\u002Fm² \\\u003C body mass index \\\u003C 25 kg\u002Fm² (microbiota modified based on BMI, (Le Chatelier et al., 2013)\n3. For women, female of child-bearing age with an active contraception (hormonal, intrauterine device, bilateral tubal occlusion, sexual abstinence\\*) and this during at least the period of treatment (up to v2) \\*Sexual abstinence is defined as refraining from heterosexual intercourse from providing consent until V3. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant\n\n   * A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH), level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient\n4. Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day\n5. Patient with health insurance (AME except)\n6. Informed Written consent Patient with IBD\n\n\u003C!-- -->\n\n1. Age ≥ 18 years and \\\u003C 50 years\n2. Crohn's Disease (Excepting disease involving only the upper GI tract) or ulcerative colitis (excepting disease involving only the rectum), according to the Lennard-Jones criteria for at least 6 months (15 patients with Crohn's disease and 15 with ulcerative colitis will be recruited)\n3. Patient in steroid-free clinical remission for at least 6 months (for Crohn's disease: CDAI \\\u003C150 the week before inclusion, for ulcerative colitis: Partial Mayo Clinic score of 0 or 1).\n4. 17 kg\u002Fm² \\\u003C body mass index \\\u003C 25 kg\u002Fm²\n5. Female of child-bearing age with an active contraception. Efficient contraception include oral contraception, intrauterine devices hormonal device, intrauterine hormone-releasing system, sterilization method and other forms of contraception with failure rate \\\u003C1%)\n\n   \\*\\* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient\n6. Regular bowel movement defined as at least 1 stool every other day and maximum 3 stools per day\n7. Patient with health insurance (AME except)\n8. Informed Written consent\n\nNon inclusion Criteria:\n\nHealthy volunteers\n\n1. Significant chronic disease and particularly chronic gastrointestinal diseases, type 1 and type 2 diabetes, renal alteration\n2. Curative long-term treatment\n3. Pregnant or breastfeeding women\\*\\* \\*\\* A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n4. blood donation in the 3 months before the study\n5. Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0 (V1)\n6. probiotics in the month preceding day 0 (V1),\n7. consumption of a low-calorie diet or any other special diet (except vegetarian) in the month before day 0\n8. abdominal surgery in the past (except for appendectomy)\n9. allergy against the antibiotics and antifungal treatment used in this study or to their excipients\n10. contra-indications to the administration of gentamicin (refer to SmPC)\n11. Participation in any other interventional study\n12. Patients under legal protection Patients with IBD\n\n\u003C!-- -->\n\n1. Pregnant or breastfeeding women\n2. blood donation in the 3 months before the study\n3. Taking antibiotic or antifungal (oral) in the previous 3 months before planned day 0\n4. probiotics in the month preceding day 0 and during the study,\n5. Ileal resection \\> 50cm or colectomy\n6. Diagnosis of Crohn's disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)\n7. Diagnosis of ulcerative colitis restricted to the rectum.\n8. Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion\n9. Participation in any other interventional study\n10. Patients under legal protection\n\nExclusion Criteria:\n\nHealthy volunteers :\n\n* Clinically significant abnormal serum\u002F plasma levels of electrolytes, creatinine, liver enzymes, thyroid stimulating hormone or blood cell count at the biological check-up of the visit v0 (screening and inclusion)\n* Infectious episode requiring antimicrobial treatment since V0\n* Severe diarrhea (increase of seven or more stools per day over baseline)\n\nPatients with IBD - Infectious episode requiring antimicrobial treatment since V0\n\n\\- IBD flare","50 Years",{"count":163,"type":22},45,[165],"PHASE2","Inflammatory Bowel Disease (IBD) often leads to poor disease control and reduced quality of life. Changes in the gut microbiota may disrupt the energy metabolism of immune cells, contributing to IBD.\n\nThis study will examine how gut microbiota affects immune cell metabolism in healthy adults and IBD patients. Healthy volunteers will be tested before and after a short antibiotic treatment, while IBD patients will be tested once.\n\nEnergy metabolism will be measured using SCENITH, a method that analyzes metabolic activity in blood immune cells.\n\nParticipants will also receive a special form of fiber (13C-labeled inulin) to track how gut bacteria break down and use this nutrient. Blood, urine, and stool samples will be analyzed to follow the metabolic fate of inulin. DNA and RNA from stool will be studied to identify which bacteria metabolize the labeled fiber.",[31,29,168],"Ulcerative Colitis (UC)",[170,171,172,173,174,175,176,177],"Energy Metabolism","Gut Microbiota","Healthy volunteers","Patients with IBD","SCENITH analysis","Antimicrobial treatment","Inulin","Biological collection","2026-03-11",{"date":180,"type":43},"2026-03-12",{"date":182,"type":43},"2026-01-02",{"date":184,"type":22},"2027-08",{"name":186,"class":78},"Assistance Publique - Hôpitaux de Paris",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":123},"100527365","the-assessment-of-infrared-treatment-for-crohns-disease-100527365","NCT06146816","The Assessment of Infrared Treatment for Crohn's Disease","An Exploratory Clinical Trial for the Assessment of Infrared Treatment for Crohn's Disease","Inclusion Criteria:\n\n1. An established Crohn's disease\n2. 18 \\\u003C age \\\u003C 80\n3. No therapy or on constant medicinal regimen throughout the study period: mesalamine at least 6 weeks, or steroids at least 2 weeks, or immunomodulatory drugs at least 12 weeks or biologics at least 12 weeks, medical cannabis at least 2 weeks before the study.\n4. CD patients will be included if their symptoms score \\>4 on the Harvey-Bradshaw index (HBI) score and\u002For fecal calprotectin level \\> 150 ug\u002Fgr.\n\nExclusion Criteria:\n\n1. BMI greater than 30 Kg\u002Fm2\n2. Any proven current infection such as Clostridioides difficile infection, positive stool culture, or parasites.\n3. Inability to sign informed consent and complete study protocol\n4. Pregnancy\n5. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.\n6. Presence of abscess and cysts in the liver\u002F kidneys or pancreas\n7. Evidence of an abdominal abscess or entero-enteric fistula.\n8. More than one CD luminal surgery or a small bowel length \\\u003C 1.5 meter","80 Years",{"count":196,"type":22},40,[25],"The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients.\n\nThe main questions it aims to answer are:\n\n1. Is infrared therapy safe for treating Crohn's disease patients?\n2. Is infrared therapy effective for treating Crohn's disease?\n\nParticipants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires.\n\nResearchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.",[31,200,29],"Inflammatory Bowel Diseases",[202,203],"inflammation","Infra-red","2026-02-22",{"date":206,"type":43},"2026-02-24",{"date":208,"type":43},"2023-09-12",{"date":210,"type":22},"2028-01",{"name":212,"class":213},"Shmuel Kivity, MD","OTHER_GOV",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":132,"minAge":18,"maxAge":161,"enrollmentInfo":221,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":123},"100621943","pregnancy-and-inflammatory-bowel-disease-100621943","NCT07377188","Pregnancy and Inflammatory Bowel Disease","MICI-Birth","Inclusion Criteria:\n\n* women between 18 and 50 years old\n* MICI diagnosed between 1988 and 2018\n* included in EPIMAD registry\n* living in Somme\n* having had at least one pregnancy\n\nExclusion Criteria:\n\n* women who has not had pregnancy\n* not included in EPIMAD register",{"count":222,"type":22},945,"Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases.\n\nDiagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.",[31,142,92,140],[31,226,227,228],"Crohn's disease","Ulcerative colitis","pregnancy","2026-02-04",{"date":231,"type":43},"2026-02-05",{"date":233,"type":43},"2020-09-18",{"date":235,"type":22},"2026-07",{"name":237,"class":78},"Centre Hospitalier Universitaire, Amiens",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":4},"100623128","validation-of-pet-questionnaire-for-experience-and-sustainability-in-telemedicine-petpatient-experience-in-telehealth-100623128","NCT07392606","Validation of PET Questionnaire for Experience and Sustainability in Telemedicine. PET(Patient Experience in Telehealth)","Assessment of Patient Experience in Telemedicine: Validation of the Co-designed \"Patient Experience in Telehealth (PET)\" Questionnaire to Measure Experience and Assess Environmental, Economic and Organizational Impact.","PET","Inclusion Criteria:\n\n* Age ≥18 years\n* Receipt of at least one telemedicine service at FPG IRCCS\n* Provision of informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Cognitive or linguistic difficulties preventing comprehension of the questionnaire, in the absence of an available caregiver to provide assistance.\n* Exclusive use of telemonitoring services or asynchronous reporting, as the survey focuses on synchronous interactions (e.g., video consultation).",{"count":247,"type":22},200,"Background: Telemedicine adoption has expanded rapidly in recent years, creating new opportunities for access to care, particularly for frail patients or those with mobility limitations. However, the large-scale deployment of remote healthcare services has highlighted the lack of validated instruments to systematically and multidimensionally assess patients' subjective experience. Patient experience is recognized as a key indicator of quality of care, with direct implications for treatment adherence, appropriate use of digital health technologies, and the effectiveness of organizational care models.\n\nRationale: No instruments have been specifically validated in Italy to measure patient experience in telemedicine. In response, the Fondazione Policlinico Universitario A. Gemelli - Istituto di Ricovero e Cura a Carattere Scientifico (FPG IRCCS) developed, through a co-design process involving expert patients and healthcare professionals, the Patient Experience in Telehealth questionnaire (PET). The tool was designed to capture not only overall satisfaction, but also relational, informational, and organizational domains, as well as perceived economic and environmental impact.\n\nObjectives: The primary objective is psychometric validation of PET, assessing reliability and validity (construct, convergent, and discriminant). Secondary objectives include evaluating the perceived impact of telemedicine on care organization, patient-borne costs, and the environment, and exploring differences according to sociodemographic variables.\n\nMethods: This cross-sectional observational study will administer PET to at least 200 adult patients who received one or more telemedicine services at FPG IRCCS within the preceding three months. Content validity will be assessed by an expert panel. Descriptive analyses, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and reliability testing will be performed. A subgroup will complete a test-retest assessment after 7-14 days.\n\nHypothesis: PET is expected to demonstrate satisfactory psychometric properties, discriminate across different levels of patient experience, and capture the perceived organizational, economic, and environmental impacts of telemedicine in healthcare delivery.",[31,250,251],"Arrythmia","Radiation Therapy Complication","NOT_YET_RECRUITING","2026-01-29",{"date":255,"type":43},"2026-02-06",{"date":257,"type":22},"2026-02-01",{"date":259,"type":22},"2027-02-01",{"name":261,"class":78},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":278,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":123},"100622161","acceptability-adherence-and-impact-on-the-bioavailability-of-iron-and-zinc-of-the-dietary-supplements-goodphyte-ib-defense-and-goodphyte-immunity-in-adults-with-chronic-diseases-100622161","NCT07380022","Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.","PHYTASE","Inclusion Criteria:\n\n* Crohn's disease: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n* Ulcerative colitis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n* Hypertension: Patients with systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg, who maintain blood pressure within these ranges through lifestyle modifications, without active symptoms (e.g., headaches, dizziness), and not receiving antihypertensive medication.\n* Anemia: Patients with hemoglobin \\\u003C12 g\u002FdL, serum iron \\\u003C40 μg\u002FdL, and ferritin \\\u003C15 ng\u002FmL for women, and hemoglobin \\\u003C13 g\u002FdL, serum iron \\\u003C40 μg\u002FdL, and ferritin \\\u003C30 ng\u002FmL for men. Absence of severe clinical consequences. Presence of fatigue, weakness, or dizziness, which is usually manageable.\n* Multiple sclerosis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Current use of antibiotics or antibiotic use within the past month\n* Current use of other probiotic, prebiotic, or synbiotic supplements\n* Current use of iron and\u002For zinc supplements\n* Change in the type of therapeutic regimen (pharmacotherapy) within the past three months\n* Change in the dosage of the therapeutic regimen (pharmacotherapy) within the past month\n* Renal or hepatic disease\n* Inability to provide informed consent (including individuals \\\u003C18 years of age)\n* Insufficient understanding of the Greek language",{"count":270,"type":22},100,[25],"The primary objective of the present postdoctoral research is to evaluate the acceptability and adherence of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity, in adult individuals with chronic diseases, namely Idiopathic Inflammatory Bowel Diseases (IIBD)-that is, Crohn's disease (CD) or Ulcerative Colitis (UC)-Arterial Hypertension (AH), Anemia (AN), or Multiple Sclerosis (MS).\n\nSecondarily, this study will investigate potential changes in iron and zinc absorption following phytase supplementation in these individuals and, consequently, possible changes in their quality of life.",[31,274,275,276,277],"Hypertension (HTN)","Multiple Sclerosis","Anemia","Colitis Ulcerative",[279,280,267],"ACCEPTABILITY","DIETARY SUPPLEMENT","2026-01-23",{"date":283,"type":43},"2026-02-02",{"date":285,"type":43},"2025-07-09",{"date":287,"type":22},"2026-02-28",{"name":289,"class":78},"University of Thessaly",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":297,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":123},"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","17 Years",{"count":300,"type":22},70,[25],"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.",[304,138,139,168,305,306,31],"Inflammatory Bowel Disease (IBD)","Indeterminate Colitis","Crohn Disease (CD)",[31,143,92,305,308],"Crohns Disease","2025-11-19",{"date":311,"type":43},"2025-11-21",{"date":313,"type":43},"2025-10-23",{"date":315,"type":22},"2027-08-31",{"name":317,"class":78},"Children's Hospital Medical Center, Cincinnati",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":87,"sex":17,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":123},"100610171","assessment-and-educational-intervention-to-reduce-ultra-processed-food-consumption-in-pediatric-patients-with-ibd-100610171","NCT07224113","Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD","Inclusion Criteria:\n\n* Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months\n* Age 10 through \\\u003C 22 years at the time of enrollment (i.e., up to the day before the 22nd birthday)\n* Followed by a gastroenterologist at Connecticut Children's\n* IBD in clinical remission based on calculated PUCAI score \\\u003C10 or PCDAI score of \\\u003C10\n* Receiving medical infusions at CCMC Infusion Center as part of IBD treatment\n* Participants must be on full oral intake and not have major dietary restrictions or require oral nutrition supplements\n\nExclusion Criteria:\n\n* Following a medically prescribed or restrictive diet such as Crohn's Disease Exclusion Diet (CDED), ketogenic diet, Specific Carbohydrate Diet (SCD), low FODMAP diet, gluten-free diet, paleo, or Whole30.\n* Receiving any nutrition through feeding tubes (including nasogastric \\[NG\\], nasojejunal \\[NJ\\], gastrostomy \\[G\\], or gastrojejunostomy \\[GJ\\] tubes)\n* History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake\n* Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)","10 Years","21 Years",{"count":327,"type":22},120,"This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.",[31,306,168,304,330,331,332],"Ultra Processed Food","Nutrition Assessment","DGBI",[31,143,29,92,334],"Ultra processed food","2025-11-17",{"date":309,"type":43},{"date":338,"type":43},"2025-11-10",{"date":340,"type":22},"2026-07-30",{"name":342,"class":78},"Connecticut Children's Medical Center",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100608950","texture-and-colour-enhancement-imaging-txi-versus-dye-chromoendoscopy-for-dysplasia-detection-in-ibd-surveillance-100608950","NCT07208214","Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.","A Randomised Parallel-group Study of Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.","TXIorDyE","Inclusion Criteria:\n\n* Patients \\>16 with inflammatory bowel disease undergoing surveillance colonoscopy.\n\n  * Patients with Crohn's (L2\u002FL3 Montreal classification) with \\>50% colonic involvement\n  * Patients with ulcerative colitis with Extensive or left sided disease (E3 or E2 Montreal classification) for at least 8 years or a diagnosis of Primary sclerosing cholangitis concomitant with IBD.\n\nExclusion Criteria:\n\n* The participant may not enter the study if ANY of the following apply:\n\n  * Disease duration \\\u003C8 years unless a diagnosis of PSC\n  * Incomplete colonoscopy\n  * BBPS \\\u003C6 or \\\u003C2 in any segment\n  * MES ≥2 or any variable of the SES-CD is ≥2 or any stenosis for \\>10cm segment (above the rectum)\n  * Previous colorectal resection\n  * Thrombocytopaenia (platelet count \\\u003C50) or Coagulopathy precluding biopsy\n  * Anticoagulation that has not been held appropriately prior to the procedure (must be held at least the morning of the procedure).\n  * Allergy to Indigo Carmine\n  * Pregnancy\n  * Unable or unwilling to consent to study participation",{"count":352,"type":22},242,[25],"In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.",[31],"2025-09-26",{"date":358,"type":43},"2025-10-06",{"date":360,"type":22},"2025-10-01",{"date":362,"type":22},"2027-07-01",{"name":122,"class":78},{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":18,"enrollmentInfo":371,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":123},"100431799","conception-of-a-diagnosis-prognosis-and-therapeutic-decision-tool-for-patients-with-autoimmunity-and-inflammation-100431799","NCT04902807","Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation","ATRACTion","Inclusion Criteria for controls (patients relatives and unrelated subjects):\n\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 6 kg\n* Individuals not affected by an immune-related disease or not affected by cancer\n* Individuals whose parents have signed an enlightened consent.\n\nInclusion criteria for patients\n\n* Individuals with health insurance.\n* Patients treated at Necker hospital with PIDs and autoimmunity\u002Finflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and\u002For Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 9 kg\n* Patients whose parents have signed an enlightened consent.\n\nExclusion Criteria:\n\n* Intake of antibiotics within 2 weeks prior inclusion\n* Absence of parent's or child consent form\n* Cytotoxic cancer treatments\n* antiviral treatments (HIV, hepatitis …)\n* Short term life-threatening conditions\n* Individuals placed under judicial protection",{"count":372,"type":22},500,"The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity\u002Finflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).",[375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,31],"Autoimmune Lymphoproliferative Syndrome","Autoimmune Cytopenia","Autoimmune Diseases","Autoimmune Anemia","Autoimmune Thrombocytopenia","Autoimmune Hepatitis","Autoimmune Diabetes","Autoimmune Rheumatologic Disease","Systemic Lupus Erythematosus","Juvenile Idiopathic Arthritis","Hemophagocytic Lymphohistiocytoses","EBV Lymphoproliferation","RAS-Associated Autoimmune Leucoproliferative Disease","Primary Immunodeficiency","APECED","IPEX","BENTA","Enteropathy, Autoimmune","Combined Immunodeficiency","2025-09-02",{"date":396,"type":43},"2025-09-08",{"date":398,"type":43},"2021-09-07",{"date":400,"type":22},"2026-06",{"name":402,"class":213},"Institut National de la Santé Et de la Recherche Médicale, France",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":417,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":123},"100357795","phase-2-fluorescence-imaging-of-ibd-and-ra-using-adalimumab-800cw-100357795","NCT03938701","Fluorescence Imaging of IBD and RA Using Adalimumab-800CW","Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Elucidate the Drug Distribution Throughout Inflamed Tissue in Inflammatory Bowel Disease and Rheumotoid Arthritis","STRATIFY","Inclusion criteria:\n\n* Established IBD or RD diagnosis\n* Active disease.\n\n  * IBD cohort: clinically active disease of the bowel defined either clinically as at least mild activity using dedicated scoring indices (for definitions of disease activity, see below) or biochemically active disease as defined by a faecal calprotectin \\> 200 µg\u002Fg;\n  * RA cohort: clinically active disease of at least one joint of the hand as assessed by a rheumatologist;\n* Age of 18 years or older and mentally competent;\n* Written informed consent.\n\nIBD patients must already have an ileocolonoscopy scheduled due to a clinical indication.\n\nFor female subjects which are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years postmenopausal\n\n* A negative pregnancy test must be available\n* Willing to ensure that she uses effective contraception during the study and for 3 months thereafter.\n\nExclusion criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;\n* A potential female subject that is pregnant or provides breastfeeding will be excluded from participation in this study.\n* The exclusion criterium that is specific for RD patients involves a skin type above type 3 according to the Fitzpatrick scale due to feasibility of the MDSFR\u002FSFF spectroscopy measurements.",{"count":412,"type":22},36,[165],"Inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are both auto-immune diseases that are characterized by chronic relapsing inflammation of respectively the ileocolonic tissue and the synovium. Pathogenesis of both auto-immune diseases is attributed to the proinflammatory cytokine tumor necrosis factor α (TNFa). Adalimumab is a human monoclonal anti-TNF antibody used for treating patients with moderate to severely active IBD and RA. However, current rates of therapeutic nonresponsiveness to this antibody are variable and difficult to predict in advance, whereas patients are potentially exposed to a non-effective treatment and its potential side effects; while clinical deterioration progresses. A key unmet need is the development of a predictive tool for assessment of a therapeutic (non-) response to patients and finding an optimal dose strategy in individual patients before initiating anti-TNF therapy. Unfortunately, we currently lack crucial information about drug distribution of the drug of interest throughout the targeted inflamed tissue itself. Therefore, it remains unknown in both IBD and RA, if the drug reaches its target (in sufficient amounts) and how local drug concentrations are related to therapeutic response. Thus, we linked adalimumab to a fluorescent dye (adalimumab-800CW) in order to create a fluorescent signal of the labelled drug in the diseased tissue that we can visualize and quantify with dedicated optical fluorescence imaging systems. We hypothesize that this tracer will bind to TNFa in the mucosa\u002Fsynovium and thus create a map of medicine distribution in vivo due to colocalization of the fluorescent labelled compound. Therefore, the aim of this study is to assess the feasibility of fluorescent molecular imaging of adalimumab-800CW in IBD and RA patients.",[31,416],"Rheumatoid Arthritis",[418,419,420,421,422],"Molecular imaging","Adalimumab-800CW","Fluorescence","Inflammatory bowel disease","Rheumatoid arthritis","2025-08-13",{"date":425,"type":43},"2025-08-19",{"date":427,"type":43},"2024-08-06",{"date":429,"type":22},"2026-08-01",{"name":431,"class":78},"University Medical Center Groningen",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":439,"maxAge":325,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":153},"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",{"count":196,"type":22},[25],"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.",[138,31,139],[445,421,31,446,447],"Ex-vivo","CLE","Confocal laser endomicroscopy","2025-08-12",{"date":450,"type":43},"2025-08-14",{"date":452,"type":22},"2025-09-01",{"date":454,"type":22},"2028-07-01",{"name":456,"class":78},"Cook Children's Health Care System",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":17,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":123},"100506576","phase-2-vancomycin-in-primary-sclerosing-cholangitis-in-italy-100506576","NCT05876182","Vancomycin in Primary Sclerosing Cholangitis in Italy","A Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease","VanC-IT","Inclusion Criteria:\n\n1. Willing and able to give informed consent prior to any study specific procedure being performed;\n2. Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;\n3. Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);\n4. Baseline ALP ≥1.5 times upper limit normal at screening;\n5. Absence of biliary obstruction and\u002For malignancy within 6-12 months of entry into the study;\n6. If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;\n7. Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry;\n8. If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry;\n9. PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score \\\u003C 220 and pMayo score \\\u003C5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit;\n10. Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception.\n11. Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n1. Receiving an antibiotic or probiotic within 3 months prior to the study;\n2. Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);\n3. Allergy to vancomycin or teicoplanin;\n4. Biliary intervention within 3 months prior to study enrollment or planned;\n5. Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);\n6. Pregnancy and lactation;\n7. Advanced renal disease (GFR\\\u003C 70);\n8. Active hepatitis B and\u002For C infection;\n9. Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer;\n10. History of CCA;\n11. Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and\u002For bilirubine \\>4 mg\u002FdL);\n12. On active transplantation list;\n13. IBD with uncontrolled moderate to severe activity;\n14. Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks\n15. Active treatment with rifampicin or within the previous three months (washout period);\n16. Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates;\n17. Treatment with any experimental drug within the previous three months;\n18. Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease);\n19. History or active hearing problems;\n20. Any active malignant disease;\n21. Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs;\n22. Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.","15 Years","70 Years",{"count":468,"type":22},84,[165],"Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications.\n\nThis is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg\u002Fday) in subject between 15 - 70 years old with PSC.",[472,473,31],"Primary Sclerosing Cholangitis","Liver and Intrahepatic Bile Duct Disorder",[475,476,477,421],"liver","oral vancomycin","primary sclerosing cholangitis","2025-07-24",{"date":480,"type":43},"2025-07-25",{"date":482,"type":43},"2023-06-15",{"date":400,"type":22},{"name":485,"class":78},"University of Milano Bicocca",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":498,"conditions":499,"keywords":500,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100596252","phase-3-randomized-controlled-trial-comparing-remote-patient-monitoring-vs-standard-care-in-ibd-patients-initiating-or-changing-advanced-therapy-100596252","NCT07043036","Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy","Randomized Controlled Trial Comparing a Strategy Based on Continuous Monitoring at Home Using a Digital Remote Patient Monitoring Solution to Reference Standard in Patients With IBD Initiating an Advanced Therapy or Undergoing a Substantial Change in Their Advanced Therapy.","GC-102","Inclusion Criteria:\n\n* Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before enrolment\n* Initiating an advanced therapy (i.e., biologic therapy or small molecule) OR occurrence of a substantial change in the treatment of the disease.\n* Active disease.\n\nExclusion Criteria:\n\n* Patients with altered intestinal continuity or function due to major abdominal surgery (e.g., stoma, extensive resection, anastomosis), uncontrolled intra-abdominal abscess, or active perianal disease.\n* Patients for whom digestive surgery is expected during the study period.\n* Patients unable or unwilling to use or already using GutyCare.\n* Vulnerable individuals as defined by French law.",{"count":495,"type":22},116,[497],"PHASE3","This clinical trial aims to evaluate whether GutyCare, a digital remote patient monitoring (RPM) solution, can enhance organizational outcomes while maintaining non-inferior clinical results in patients with inflammatory bowel disease (IBD) who are initiating or undergoing significant modifications in advanced therapy.\n\nThe study compares standard care to an intervention involving the use of GutyCare, a mobile application that collects patient-reported outcomes related to symptoms.\n\nWhen clinically significant symptoms are identified, alerts are transmitted to the care team, facilitating timely and personalized therapeutic adjustments.",[31],[501,502,503,504,505,506],"Remote Patient Monitoring","Digital medicine","GutyCare","Resilience","PRO","Patient-reported Outcomes","2025-06-20",{"date":509,"type":43},"2025-06-29",{"date":511,"type":22},"2025-06",{"date":513,"type":22},"2027-06",{"name":504,"class":50},{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":522,"minAge":18,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":123},"100419347","threonine-requirement-in-adult-males-with-crohns-disease-using-iaao-100419347","NCT04740541","Threonine Requirement in Adult Males With Crohn's Disease Using IAAO","Determination of Threonine Requirement in Adult Males With Crohn's Disease Using the Indicator Amino Acid Oxidation (IAAO) Methodology","Inclusion Criteria:\n\n* Male 18 - 49 years of age\n* Having obtained his (or his legal representative's) written informed consent\n* Evidence of ileal and or colon inflammatory involvement and clinically stable disease state and HBI ≤ 8\n* Evidence of some active disease based on history of elevated CRP or parameters of active mucosal\n* No evidence of intestinal strictures that may affect the subjects' ability to consume a normal diet\n* Have maintained a stable weight for at least 3 months and not on enteral feed via tube\n* Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire) and willingness to consume the diet provided\n\nExclusion Criteria:\n\n* Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks\n* Concomitant treatment: corticosteroid \\> 20 mg\u002Fday\n* Subjects without any evidence of inflammatory activity\n* On medications known to affect protein and amino acid metabolism (steroids)\n* Recent significant weight loss\n* Individual on weight reducing diets\n* Inability to tolerate the diet\n* Subjects who cannot be expected to comply with the study procedures\n* Significant coffee consumption of more than 2 cups\u002Fday\n* Significant alcohol consumption of more than one drink\u002Fday","MALE","49 Years",{"count":525,"type":22},10,[25],"The goal of the current study is to measure the requirement for threonine in patients with CD using the IAAO method and compare the requirement to previously determined threonine requirement estimated in young adults using the IAAO technique. It is hypothesize that the requirement for threonine in patients with CD will be higher than the threonine requirement previously determined in young adults using the IAAO method. Up to 10 clinically stable patients with CD will be recruited from the IBD Clinic at Mt. Sinai Hospital, Toronto, and subsequently followed up at the Clinical Research Center (CRC), The Hospital for Sick Children (SickKids), Toronto, Canada. Before the study begins, the participants will be required to visit the CRC (Room 5500 Hill Wing, The Hospital for Sick Children) for a pre-study assessment of their height, weight, fat mass, fat free mass, resting metabolic rate and medical history. These assessments will take about 3 hours to complete. They will need to have been fasted for 10 hours prior to the pre-study assessment. The pre-study assessment is needed to calculate their dietary requirements for the study, and to assess health status. After signing the consent form, the subjects will complete the screening procedures (height, weight, fasting blood sample and medical history questionnaire, BIA, Skinfold and calorimetry).\n\nEach study will consist of a 2-day adaptation period to a prescribed diet in accordance with the energy requirement of the subject and 1-study day. The diet will provide an adequate amount of protein, of 1 g protein\u002Fkg\u002Fd. The 2-day adaptation period is to allow the body to adapt to an adequate amount of protein as it has been shown that protein kinetics is altered without it.\n\nDietary intakes during this time will be provided in the form of lactose-free milk shakes (Scandishake) with added carbohydrate (SolCarb) and protein (beneprotein) to meet the subjects' requirement.\n\nFollowing the 2 days of adaptation is the study day where threonine intake will be randomly assigned and phenylalanine (Phe) kinetics will be measured with the use of isotopically labelled Phe. On this day, VCO2 will be measured by calorimetry immediately after the 5th meal for a period of 20 minutes.\n\nOn the study day (3rd day of each 3-day period), the diet will be provided as 8 hourly isocaloric, isonitrogenous meals made up of a flavored liquid formula and protein free cookies developed for use in amino acid kinetic studies. Each meal will represent 1\u002F12th of the subject's total daily requirements. The nitrogen (protein) content of the diet will be provided in the form of a crystalline amino acid mixture based on the amino acid composition of egg protein.\n\n* A daily multivitamin supplement will be provided during the study period.\n* No other food or beverages will be consumed on the adaptation days except water, 1 cup clear tea, or 1 cup clear coffee.\n* During the 8-hr study day, no other food or drink will be consumed except water.\n* Urine and breath samples will be collected at baseline and at isotopic steady state.\n* Breath samples will be collected simultaneously with urine samples.\n* Five baseline breath samples will be collected 60, 45, 30, 15 min, and just before the tracer protocol begins.\n* Three baseline urine samples will be collected 60, 30 min, and just before the tracer protocol begins.\n* Four plateau breath samples will be collected every 15 minutes 2.5 h after the tracer protocol begins.\n* Three plateau breath samples will be collected every 30 minutes 2.5 h after the tracer protocol begin\n* Breath samples will be collected with subjects breathing into an Exetainers plastic tube and samples will be stored in pre-evacuated glass tubes at room temperature until analysis.\n* Urine samples will be collected in Eppendorf tubes and stored at - 20 º C until analyzed for 1-13C phenylalanine enrichment.\n* The rate of CO2 production (VCO2) will be measured on each testing day using a ventilated hood indirect calorimeter at meal 5 to quantify 13CO2 excretion in breath.\n\nSubjects can choose to withdraw from the study at any time and for any reason, based on his\u002Fher individual judgment. In particular, if a subject is unable to tolerate the diet, whether it is regards to taste, loose stools or constipated stools, he\u002Fshe has the right to withdraw at any time during the study.",[29,31],[530,531],"indicator amino acid oxidation","threonine requirement","2025-05-23",{"date":534,"type":43},"2025-05-30",{"date":536,"type":43},"2024-02-02",{"date":538,"type":22},"2027-08-30",{"name":540,"class":78},"The Hospital for Sick Children",{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":194,"enrollmentInfo":549,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":123},"100174962","stavanger-university-hospital-inflammatory-bowel-disease-trial-100174962","NCT01551563","Stavanger University Hospital Inflammatory Bowel Disease Trial","Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue","SUSI","Inclusion Criteria:\n\n* newly diagnosed IBD\n\nExclusion Criteria:\n\n* previous IBD with specific treatment within 10 year\n* inability to consent\n* inability to adhere to treatment protocol",{"count":550,"type":22},700,"The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.\n\nCytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.",[31],"2025-05-13",{"date":555,"type":43},"2025-05-16",{"date":557,"type":4},"2012-04",{"date":559,"type":22},"2030-12",{"name":561,"class":213},"Helse Stavanger HF",{"id":563,"slug":564,"hasResults":11,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":582,"leadSponsor":584,"locationsCount":4},"100556473","the-presence-of-microplastics-and-nanoplastics-in-the-humans-ileum-colon-and-rectum-and-their-relation-with-inflammatory-bowel-disease-ibd-100556473","NCT06525558","The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD)","The Presence of Microplastics and Nanoplastics in the Humans Ileum, Colon, and Rectum and Their Relation With Inflammatory Bowel Disease (IBD): A Cross-sectional Observational Study","MATISSE","Inclusion Criteria:\n\n* Patients who will undergo any type of bowel surgery due to any type of clinical condition, as established by normal clinical practice, where colon, ileum and\u002For rectum resection is involved.\n* Patients aged ≥ 18 years.\n* Patients who have read, understood, accepted, and signed the informed consent to the study.\n* Female patients within and outside of childbearing age (breastfeeding women can be included in the study)\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years.\n* Pregnant women.\n* Patients who have not accepted informed consent.",{"count":571,"type":22},102,"Based on recent studies it is hypothesized that microplastics and nanoplastics (MNPs) are present in human's ileum, colon, and rectum and that their presence may have a correlation with Inflammatory Bowel Disease (IBD).\n\nThis study is a cross-sectional, single-center, non-profit observational study. The main objectives are to define in vitro the presence of MNPs in the humans ileum, colon, and rectum and to evaluate if there is a correlation between this presence and IBD. In vitro metabolomics and proteomics analyses of the study sample and the assessment of participants' daily plastic exposure are considered exploratory objectives. For this purpose, a total of 102 patients undergoing a surgery where intestinal resection is included, will be enrolled.",[31],[575,576,577,31],"Microplastics","Nanoplastics","Human Intestine","2025-04-29",{"date":580,"type":43},"2025-05-02",{"date":511,"type":22},{"date":583,"type":22},"2025-12-30",{"name":585,"class":78},"Pierpaolo Sileri",{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":4},"100575443","role-of-altered-intestinal-permeability-and-lipopolysaccharide-in-thrombotic-risk-and-vascular-injury-in-ibd-patients-100575443","NCT06772350","Role of Altered Intestinal Permeability and Lipopolysaccharide in Thrombotic Risk and Vascular Injury in IBD Patients","Role of Altered Intestinal Permeability and Lipopolysaccharide in Thrombotic Risk and Vascular Injury of Patients With Chronic Inflammatory Bowel Disease","PERVASC-IBD","Inclusion Criteria:\n\n* Diagnosis of IBD (both CD and UC, both in active and quiescent stages of disease)\n* Age \\> 18 years\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Other inflammatory states other than IBD (e.g., neoplasm, autoimmune diseases, liver cirrhosis)\n* Age \\\u003C 18 years\n* Pregnant woman\n* Lack of informed consent",{"count":270,"type":22},[25],"Chronic inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), are characterized by chronic immune-mediated inflammation primarily affecting the gastrointestinal tract. Venous and arterial thromboembolic events are significant extra-intestinal manifestations of IBD, but their pathogenic mechanisms are not fully understood. IBD patients have double the risk of venous thromboembolism (VTE) compared to the general population, with particularly high risk in pediatric patients, and an increased mortality rate. They also face a higher risk of early atherosclerosis and future cardiovascular events, such as myocardial infarction, ischemic stroke, and peripheral artery disease. The prevalence of thromboembolic events in IBD ranges from 1.3% to 7.7%, with venous events at around 5% and ischemic heart disease, cerebrovascular disease, and peripheral artery disease at 1-2%.",[31],"2025-03-12",{"date":600,"type":43},"2025-03-13",{"date":602,"type":22},"2025-06-15",{"date":604,"type":22},"2036-06-15",{"name":261,"class":78},{"id":607,"slug":608,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":616,"conditions":617,"keywords":618,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":153},"100522974","ibd-cancer-and-serious-infections-in-france-i-care-2-100522974","NCT06089590","Ibd CAncer and seRious Infections in France (I-CARE 2)","I-CARE 2","Inclusion Criteria:\n\n* Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.\n* Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.\n\nExclusion Criteria:\n\n* Patient unable to sign the informed consent form\n* Patient with no regular access to internet\n* Patient refusing to sign the informed consent form\n* Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)","75 Years",{"count":615,"type":22},6000,"This is a French prospective longitudinal observational multicentre cohort study.\n\nPrimary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.",[31,92,29],[619,620],"UC","CD",{"date":622,"type":43},"2025-03-14",{"date":624,"type":43},"2024-01-25",{"date":626,"type":22},"2031-03-01",{"name":628,"class":78},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives",{"id":630,"slug":631,"hasResults":11,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":466,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":643,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":649,"leadSponsor":651,"locationsCount":4},"100582184","psychological-intervention-for-fatigue-in-inflammatory-bowel-diseases-100582184","NCT06860009","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases","Psychological Intervention for Fatigue in Inflammatory Bowel Diseases: a Randomized Controlled Trial","PEARL","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. Males and females 18-70 years old.\n3. Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), inflammatory bowel disease type unclassified (IBDU) based on radiology, endoscopy and\u002For histology\n4. Patients with a disease duration of more than one year\n5. Patients with a score of \\\u003C30 on the FACIT Fatigue scale\n6. Patients possessing a smartphone\n7. Patients with an availability to commit to daily behavioural changes\n8. Patients being fluent in Dutch.\n\nExclusion Criteria:\n\n1. Patients that initiated new IBD medication (steroids, mesalamine, thiopurines, methotrexate, biologicals or small molecules) in the past three months prior to screening\n2. Patients with objective signs of active disease (CRP\\\u003C10mg\u002FL or faecal calprotectin \\\u003C250µg\u002Fg) at screening\n3. Participation in an interventional Study with an investigational medicinal product (IMP) or device at screening\n4. Patients with planned surgery at screening\n5. Patients with an iron (\\\u003C65 µg\u002FdL), vitamin D (\\\u003C11 µg\u002FL), vitamin B12 (\\\u003C197 ng\u002FL) or folic acid (\\\u003C3.9 µg\u002FL) deficiency or malnutrition (weight loss \\>10-15% within six months, BMI \\\u003C18.5 kg\u002Fm², NRS \\>5 or serum albumin \\\u003C30 g\u002FL) at screening\n6. Patients with thyroid dysfunction or hypophosphatemia at screening\n7. Patients with physical injury (according to researcher's interpretation) at screening\n8. Patients with self-reported sleep disturbance or periods of apnoea at screening\n9. Patients with BMI \\>30 kg\u002Fm² at screening\n10. Patients with present or past diagnosis of severe psychiatric disease diagnosis (ongoing major depression, schizophrenia, bipolar disease, ongoing substance abuse) at screening\n11. Patients that initiated new psychotropic medication or had a changed dosage of psychotropic medication in the past three months prior to screening",{"count":638,"type":22},155,[25],"The investigators would like to evaluate the effect of a multicomponent psychological treatment on fatigue as a symptom of patients with inflammatory bowel diseases (IBD). The intervention will be a combined program consisting of a psychological intervention (Acceptance and Commitment Therapy) and a behavioral intervention (implementation of frequent short naps and graded increase of physical activity). Next to the hypothesized effect on fatigue, the investigators will also measure the effect on fatigability, IBD related disability, anxiety, depression, stress, disease acceptance and perceived control as well as (biomarkers of) disease activity.",[31,642,168],"Crohn's Diseases",[644,31],"fatigue","2025-03-05",{"date":647,"type":43},"2025-03-10",{"date":452,"type":22},{"date":650,"type":22},"2027-10-30",{"name":652,"class":78},"Universitaire Ziekenhuizen KU Leuven",{"id":654,"slug":655,"hasResults":11,"nctId":656,"briefTitle":657,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":11,"sex":17,"minAge":439,"maxAge":60,"enrollmentInfo":660,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":662,"conditions":663,"keywords":4,"overallStatus":252,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":4},"100533575","from-nature-to-bedside--algae-based-bio-compound-for-prevention-and-treatment-of-inflammation-pain-and-ibd-100533575","NCT06227598","From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD","Algae4IBD","Inclusion Criteria:\n\nSUBJECTS WITH THE DIAGNOSIS OF UC OR CD:\n\n* subjects undergoing endoscopy and biopsies collection per standard of care\n* patients ≥2 and \\\u003C60 years\n\nAdditionally, for people with UC:\n\n\\- clinical and endoscopic evaluation (Mayo score≥2)\n\nAdditionally, for individuals with CD:\n\n\\- clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) \\>2)\n\nSUBJECTS NOT AFFECTED BY UC OR CD:\n\nsubjects undergoing endoscopy and biopsies collection (≥2 and \\\u003C60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea) subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria All patients will sign the informed consent.\n\nExclusion Criteria:\n\nSUBJECTS WITH THE DIAGNOSIS OF UC OR CD:\n\n\\- subjects with UC or CD who do not have the previously described clinical and endoscopic evaluation criteria\n\nSUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP):\n\n-subjects undergoing anti-inflammatory and\u002For immunosuppressive treatments for other diseases not related to UC or CD",{"count":661,"type":22},90,"This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https:\u002F\u002Falgae4ibd.eu\u002F), where Dept. of Molecular Medicine and Medical Biotechnologies (DMMBM) University of Naples Federico II participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO\u002FFECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert.\n\nIBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life.\n\nAlgae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule\u002Fcompounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, DMMBM is in charge with work package (WP) 4, task 4.4.2, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as \"natural compounds\" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.",[31],"2024-01-18",{"date":666,"type":43},"2024-01-29",{"date":668,"type":22},"2024-05-01",{"date":670,"type":22},"2026-09-01",{"name":672,"class":78},"Federico II University"]