[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-in-remission\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-in-remission":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100648385","phase-4-safety-and-efficacy-of-a-stopping-strategy-versus-classical-maintenance-dose-of-jak-inhibitors-in-deep-remission-patients-with-ulcerative-colitis-100648385",false,"NCT07718529","Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis","Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis: a Randomized Controlled Trial","STOP","Inclusion Criteria:\n\n1. Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and\u002For radiological criteria.\n2. Male or female age ≥ 18 years\n3. Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.\n4. Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months.\n5. Clinical steroid free remission for at least 6 months, defined by a partial Mayo Score \\\u003C 2, with no subscore \\> 1 and rectal bleeding (RB) subscore of 0 (annex 1).\n6. Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1).\n7. Fecal calprotectin ≤ 150μg\u002Fg.\n8. Without known risk factors for venous thromboembolism (VTE).\n9. Without known risk factors for major adverse cardiovascular events (MACE).\n10. Without known risk factors for malignancy.\n11. For women of child-bearing potential (WOCBP), and for men with partners who are WOCBP, willingness to use appropriate and efficient contraception, as recommended when using JAK inhibitor treatment (notably upadacitinib), during all the experimental treatment and until at least 4 weeks after the end of the experimental treatment, according to SmPC and CTFG (Clinical Trials Facilitation and Coordination Group) recommendations.\n12. Patients able to understand information provide to them and to give written informed consent for study.\n13. Affiliation to a social security scheme.\n14. Good general health according to history and clinical examination.\n\nExclusion Criteria:\n\n1. Steroid use ≤ 6 months prior to enrolment.\n2. Currently treated by steroid, immunosuppressive agents or biologics.\n3. Pregnancy or planned pregnancy during the study.\n4. Breastfeeding.\n5. Non-compliant subject or inability to follow study protocol.\n6. Intolerance of JAK inhibitors (excipients included) or severe adverse event.\n7. Contraindications to using a JAK inhibitor (excipients included).\n8. Known risk factors for VTE.\n9. Known risk factors for MACE.\n10. Active neoplasia or history of malignant tumours less than 5 years old.\n11. Participation to another interventional study protocol (except for RIPH3 studies)\n12. Severe hepatic insufficiency.\n13. Severe to end-stage renal insufficiency.\n14. Active tuberculosis, serious infections such as septicemia or opportunistic infections.\n15. Absence or refusal of informed consent.\n16. People under guardianship, conservatorship, or judicial protection;\n17. People receiving psychiatric care;\n18. People who have been deprived of their liberty by judicial or administrative order\n19. People with difficulty understanding and\u002For cognitive disorder","ALL","18 Years",{"count":20,"type":21},224,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates",[27],"Ulcerative Colitis in Remission",[29,30],"ulcerative colitis","treatment removal","NOT_YET_RECRUITING","2026-07-17",{"date":34,"type":35},"2026-07-22","ACTUAL",{"date":37,"type":21},"2027-01",{"date":39,"type":21},"2031-01",{"name":41,"class":42},"Assistance Publique Hopitaux De Marseille","OTHER",22,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100565492","evaluation-of-prolife-10-forte-on-gut-microbiota-composition-in-uc-patients-100565492","NCT06642883","Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients","Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase","ProZ-UC","Inclusion Criteria:\n\n* Diagnosis of UC confirmed by clinical, endoscopic, and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic, and histopathological evidence.\n* Age between 18 and 75 years old.\n* Ability of the subject to participate fully in all aspects of this clinical trial.\n\nExclusion Criteria:\n\n* Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.\n* Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis.\n* Positive stool culture for active C. difficile.\n* Pregnant women.\n* Allergy to soy or fructose (contained in Prolife 10 FORTE)\n* Patients under antibiotic and\u002For probiotic treatment within 10 days before visit1.","75 Years",{"count":54,"type":21},70,[56],"NA","This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are:\n\n* Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis?\n* Is it possible to highlight the variation in microbial pathways?\n* What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota.\n\nParticipants will:\n\n* Take 1 vial\u002Fday of Prolife 10 Forte \u002FPlacebo for 60 days.\n* Visit the clinic two times for checkups, Questionaire and tests",[27],[60],"Microbiota, Probiotics","RECRUITING","2024-10-14",{"date":64,"type":35},"2024-10-15",{"date":66,"type":35},"2024-05-15",{"date":68,"type":21},"2026-06-15",{"name":70,"class":42},"University of Padova",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":71},"100560404","effect-of-procyanidins-in-leaky-gut-repairing-in-ibd-100560404","NCT06576700","Effect of Procyanidins in Leaky Gut Repairing in IBD","Effect of Procyanidins in the Leaky Gut Repairing Associated with Inflammatory Bowel Disease","EcoVitis","Inclusion Criteria:\n\n* Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.\n\n  * Age between 18 and 75 years old\n  * Ability of subject to participate fully in all aspects of this clinical trial.\n\nExclusion Criteria:\n\n* ● Patients that have active UC, determined by clinical, endoscopic and histopathological evidences\n\n  * Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis\n  * Positive stool culture for active C. difficile\n  * Pregnant women\n  * Patients under antibiotic and\u002For probiotic treatment within 10 days prior to Visit 1.","80 Years",{"count":82,"type":21},25,[56],"The goal of this clinical trial is to learn if the Grape Seed Extract Ecovitis, featuring low monomeric catechins content and a high concentration of oligo-polymeric procyanidins, could modulate the Gut Microbiota composition of Ulcerative Colitis patients during the remission phase. The main questions it aims to answer are:\n\nDoes Ecovitis improve the microbiota composition in patients with Ulcerative colitis? Is the intestinal permeability affected? What about the variation in the quality of life?\n\nParticipants will:\n\nTake 2 capsules\u002Fday of Ecovitis for eight weeks Visit the clinic two times for checkups, serum collection, and Questionaire.",[27],[87,88,89],"Microbiota","proanthocyanidine","polyphenols","2024-09-03",{"date":92,"type":35},"2024-09-19",{"date":94,"type":35},"2024-06-15",{"date":96,"type":21},"2026-06-12",{"name":70,"class":42}]