[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pouchitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pouchitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,67,130,155,184,212,234,256,283],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100630380","phase-2-etrasimod-as-prevention-of-pouchitis-100630380",false,"NCT07486921","Etrasimod as Prevention of Pouchitis","Etrasimod as Primary and Secondary Prevention of Pouchitis (ESPIRIT)","ESPIRIT","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years (verified at screening)\n* Ability to provide written informed consent and to be compliant with protocol assessments (verified at screening)\n* Diagnosed with UC and underwent TPC with IPAA for medically refractory disease or dysplasia (verified at screening)\n* Screening may take place at any time from one month to two years after the final surgical stage\n* High-risk of developing acute pouchitis - defined as fulfilling at least one of the criteria defined in section 2 (verified at screening)\n* Patients with 1 prior episode of acute pouchitis can be enrolled - after a minimum period of 4 weeks after completion of a course of antibiotics and resolution of symptoms of pouchitis\n* Symptomatic remission defined by a symptom mPDAI subscore ≤2 points at the baseline visit (verified at screening, baseline)\n* Adequate hematological function defined by white blood cell count ≥ 3.5 × 109\u002FL with absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, absolute lymphocyte count (ALC) ≥ 0.8 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 8 g\u002FdL (verified at screening)\n* Healthcare professional-confirmed history of varicella or a full course of vaccination against varicella zoster virus (VZV) or a positive antibody test to VZV (verified at screening)\n* 12-lead electrocardiogram (ECG) that showed no clinically significant abnormalities as defined by the clinician's judgement (verified at screening)\n* Females must be non-pregnant, as determined by qualitative urine hCG testing, non-lactating, and if premenopausal, must agree to using a highly effective contraception method (that can achieve a failure rate of less than 1% per year when used consistently and correctly) during treatment and for one week after stopping treatment with etrasimod (verified at screening)\n\nExclusion Criteria:\n\n* Isolated cuffitis (verified at screening pouchoscopy)\n* Diagnosis of Crohn's disease (verified at screening)\n* Diagnosis of Crohn's disease-like pouch inflammation (verified at screening)\n\n  o Crohn's disease-like pouch inflammation is defined as ulcerations of the pre-pouch ileum extending \\> 10 cm above the inlet, strictures in the pre-pouch ileum or pouch body outside of the anastomoses, and\u002For fistulae of the pre-pouch ileum, pouch body, or perineum\n* Diagnosis of chronic pouchitis (verified at screening)\n\n  o Chronic pouchitis is defined as persistent (\\> 4 weeks) or recurrent (\\> 4 episodes\u002Fyear) symptoms of pouchitis\n* Anastomotic stenosis or other mechanical complications of the pouch (verified at screening pouchoscopy)\n* Treatment with probiotics ≤ 3 months prior to screening (verified at screening)\n* Treatment with topical rectal 5-ASA, or steroids ≤ 2 weeks prior to or during screening (verified at screening)\n* Any use of a biologic or small molecule approved for moderately to severely active UC or investigational, after TPC with IPAA (verified at screening)\n* Any prior exposure to a S1P receptor modulator therapy, at any time (verified at screening)\n* Any investigational or biologic agent within 30 days of screening pouchoscopy (verified at screening)\n* Have the following cardiovascular history (verified at screening):\n\n  * In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure\n  * Have a history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker\n  * A history of symptomatic bradycardia, recurrent cardiogenic syncope, Mobitz type I second-degree AV block, or severe untreated sleep apnea\n  * Significant QT prolongation (QTcF interval ≥ 450 ms in male or ≥ 470 ms in females)\n  * Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs\n* Clinically significant or serious active infection ≤ 28 days prior to baseline - including but not limited to (verified at screening):\n\n  * Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or\n  * positive test for Clostridioides difficile toxin at screening\n  * Active tuberculosis\n  * Acute or chronic hepatitis B or hepatitis C\n  * HIV infection\n* Pregnancy, lactation, or a positive urine pregnancy test measured during screening\n* Severe hepatic impairment (Child Pugh Class C) (verified at screening)\n* Have a known history of macular edema or retinopathy (verified at screening)\n* History of cancer within the last 5 years (excluding in situ squamous or basal cell carcinoma of the skin that has been excised and resolved) or current malignancy (verified at screening)\n* History of posterior reversible encephalopathy syndrome (PRES)\n* Have a history of any clinically significant medical condition that, in the investigator's opinion, precludes participation in the study (verified at screening)","ALL","18 Years","65 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The researchers propose conducting a multi-center, randomized, placebo-controlled study to investigate the potential role of etrasimod for the primary and secondary prevention of pouchitis among high-risk patients submitted to total proctocolectomy (TPC) with ileal-pouch anal anastomosis (IPAA) for medically refractory disease. The trial will be conducted in compliance with this protocol, Good Clinical Practice guidelines, and Institutional Review Board requirements.",[28],"Pouchitis","RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-10","ACTUAL",{"date":35,"type":22},"2026-06-12",{"date":37,"type":22},"2030-02-06",{"name":39,"class":40},"Maia Kayal","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100610320","phase-2-clf065-for-chronic-pouchitis-100610320","NCT07226050","CLF065 for Chronic Pouchitis","A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis","OPUS","Inclusion Criteria:\n\n1. Adult subjects aged 18-80 years, inclusive.\n2. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.\n3. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n4. Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:\n\n   ≥ 3 episodes of pouchitis within 1 year of Screening visit, each treated with antibiotic or other prescription therapy for at least 2 weeks OR Requiring maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the Baseline endoscopic visit\n5. The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.\n6. The patient agrees that antibiotic therapy will be managed per investigator discretion in accordance with standard of care.\n7. Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.\n8. A male subject who is nonsterilized and sexually activity with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing informed consent throughout the duration of the study.\n9. Women of childbearing potential must not have a positive pregnancy test at the Screening Visit and must have a negative pregnancy test at the baseline visit prior to study drug dosing. Note: subjects with borderline serum pregnancy test at Screening must have an absence of clinical suspicion of pregnancy or other pathological cause of a borderline result and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.\n10. If female, the patient must be either postmenopausal, OR permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, that is effective from baseline visit through at least 30 days after the last dose of study drug.\n11. Patient is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination\n\nExclusion Criteria:\n\n1. Inability to give informed consent.\n2. The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)\n3. No prior exposure to CLF065\n4. Chronic pouchitis specific:\n\n   1. The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Randomization Visit\n   2. Crohn's disease with disease proximal to the pouch inlet confirmed on prior imaging or endoscopy\n   3. Irritable pouch syndrome\n   4. Predominate or isolated cuffitis\n   5. Mechanical complications of the pouch\n   6. Diverting stoma\n   7. Planned surgical intervention of the pouch\n5. History of malignancy including melanoma (with the exception of localized skin cancers, carcinoma in situ of the cervix and localized prostate cancer) within 2 years of study enrollment\n6. Pregnant or breast feeding.\n7. Lack of effective contraception in women of childbearing potential.\n8. Ongoing treatment with NSAID (nonsteroidal anti-inflammatory drug).\n9. Anastomotic or anal canal stricture which precludes endoscopic evaluation.\n10. The patient has evidence of pelvic sepsis and pelvic penetrating fistulizing disease on clinical exam.\n11. Known diagnosis of primary sclerosing cholangitis.\n12. Fecal transplantation within 12 weeks prior to study enrollment.\n13. History of clinically significant medical conditions or any other reason that in the opinion of the investigator would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug or would put the subject at risk by participating in the study.\n14. The patient has any of the following laboratory abnormalities during the Screening Period:\n\n    1. Hemoglobin level \\\u003C8 g\u002FdL\n    2. White blood cell (WBC) count \\\u003C3 x 109\u002FL\n    3. Platelet count \\\u003C100 x 109\u002FL or \\>1200 x 109\u002FL\n    4. Serum creatinine \\>2 x ULN\n    5. Alanine aminotransferase (ALT) or aspartate aminiotransferase (AST) \\>2x ULN\n    6. Alkaline phosphatase \\>2 x ULN","80 Years",{"count":52,"type":22},20,[25],"This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.",[28],[57],"chronic pouchitis","2026-05-29",{"date":60,"type":33},"2026-06-01",{"date":60,"type":22},{"date":63,"type":22},"2027-06",{"name":65,"class":40},"Calibr, a division of Scripps Research",3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100611443","phase-4-outcomes-from-hyperbaric-oxygen-hbo2-treatment-for-emerging-indications-100611443","NCT07240649","Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications","Emerging Indications for Hyperbaric Oxygen Treatment","Inclusion Criteria:\n\n* Patients referred for HBOT with an emerging indication\n\nExclusion Criteria:\n\n* Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)\n* Pregnant persons",{"count":75,"type":22},100,[77],"PHASE4","This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.",[80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,28,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119],"Post-COVID-19 Condition","Ulcerative Colitis","Crohn Disease","Calciphylaxis","Frostbite","Acute COVID-19","Pyoderma Gangrenosum","Pterygium","Hypospadias","Head Trauma","Pneumatosis Intestinalis","Ischemic Bowel","Raynaud Syndrome","Malignant Otitis Externa","Nonarteritic Anterior Ischemic Optic Neuropathy","Central Retinal Vein Occlusion","Femoral Head Necrosis","Invasive Fungal Infection","Chronic Anal Fissure","Vasculitic Ulcer","Graft-vs-Host Disease","Decubitus Ulcer","Greater Trochanteric Pain Syndrome","Rectovaginal Fistula","Tinnitus","Clostridium Enterocolitis","Branch Retinal Artery Occlusion","Axonotmesis","Multiple Sclerosis","Inclusion Body Myositis","Epidermolysis Bullosa (EB)","Osteonecrosis","Ulcer Ischemic","Avascular Necrosis of Bone","Prosthesis Related Infections","Facial Filler Injections","Cystitis Chronic","Ligament Injury","Anastomosis, Leaking","Cartilage Injury","NOT_YET_RECRUITING","2026-05-01",{"date":123,"type":33},"2026-05-05",{"date":125,"type":22},"2026-08",{"date":127,"type":22},"2035-12",{"name":129,"class":40},"Jay C. Buckey Jr.",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":41},"100586516","phase-4-guselkumab-intervention-and-diet-evaluation-for-pouchitis-100586516","NCT06916390","GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis","Guselkumab Intervention and Diet Evaluation for Pouchitis","GUARDIAN","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n4. Participant with a proctocolectomy and IPAA for UC who heveloped chronic or relapsing pouchitis, defined as mPDAI score ≥5 and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:\n\n   1. ≥2 recurrent episodes within 1 year prior to the screening visit, each treated with ≥2 weeks of antibiotic or other prescription therapy, or\n   2. patients treated with maintenance antibiotic therapy taken continuously for four consecutive weeks before the screening visit and who are refractory to this antibiotic therapy, or\n   3. previously failure of another biologic therapy to treat chronic pouchitis.\n5. The subject agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study. For patients who did previously not tolerate quinolone therapy, an alternative antibiotic therapy between Day 1 and Week 4 with metronidazole (500 mg three times a day) will be allowed. (Additional courses of antibiotics will be allowed, as needed, for flares after Week 16.)\n\nAll participants that are considered for Trial participation, per the above criteria will be documented via applicable log forms in Investigator Site File (including Screen Failures).\n\nExclusion Criteria:\n\n1. Crohn's disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectious pouchitis, diverting ostomy or mechanical complications of the pouch\n2. Previous treatment with an anti-IL12\u002F23 or an anti-IL23 antibody\n3. Any investigational or approved biologic agent within 30 days of screening\n4. Nonbiologic investigational therapy or JAK inhibitors within 30 days prior to screening\n5. Active or untreated latent tuberculosis (TB). In case of a newly identified positive diagnostic TB test result (defined as a positive tuberculin skin test) , active TB has to be ruled out and appropriate treatment for latent TB has to be initiated for a minimum of 4 weeks prior to the first administration of study medication.\n6. Chronic hepatitis B virus (HBV)\\* infection, chronic hepatitis C virus (HCV)\\*\\* infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient (e.g., due to organtransplantation, history of common variable immunodeficiency, etc). \\* Subjects who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For subjects who are negative for HBsAg but are positive for either surface antibodiesand\u002For core antibodies, HBV DNA polymerase chain reaction will be performed and if anytest result meets or exceeds detection sensitivity, the subject will be excluded.\\*\\* If subject is HCV antibody positive, then a viral load test will be performed. If the viralload test is positive then the subject will be excluded.\n7. Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)\n8. The subject has allergies to and\u002For contraindications for ciprofloxacin and metronidazole\n9. Participant has a history of malignancy or current malignancy, except for the following: adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer and cervical carcinoma in situ. Subjects with a remote history of malignancy (e.g., \\>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy.\n10. Any disorder or laboratory abnormalities which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n11. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial (see list in 5.3).\n12. Female who is pregnant, breast-feeding or intends to become pregnant before, during, or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period or is of child-bearing potential and not using an adequate, highly effective contraceptive or males who want to make their partner pregnant or intends to donate sperm during the course of this study or for 18 weeks after the last dose of study drug\n13. Participation in another interventional Trial with an investigational medicinal product (IMP) or device.\n\nParticipants who meet one or more of the above exclusion criteria must not proceed to be enrolled\u002Frandomized in the Trial and will be identified via applicable log forms in Investigator Site File.",{"count":52,"type":22},[77],"Restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) is considered the procedure of choice in patients with ulcerative colitis (UC) refractory to medical therapy or with neoplasia. The most common complication after IPAA is the development of pouchitis. Pouchitis is clinically characterized by variable symptoms including increased stool frequency, altered consistency, bloody stools, abdominal cramping, urgency, and incontinence. Symptomatic pouchitis longer than four weeks is considered chronic pouchitis.\n\nThe conventional treatment for acute and chronic pouchitis is antibiotics, such as metronidazole and ciprofloxacin. The disease course of antibiotic responsive pouchitis may evolve into antibiotic dependent (requiring antibiotic maintenance therapy) pouchitis and then antibiotic refractory (no response to antibiotic treatment) pouchitis. Although many patients respond to antibiotic therapy, there is also evidence that suggest that aberrant regulation of the mucosal immune system might play a part in the pathogenesis of pouchitis arising from an abnormal mucosal immune response to a dysbiosis of the pouch microbiota. If individuals fail to respond to antibiotics, anti-tumor necrosis factor (anti-TNF) agents and vedolizumab have been proposed for the treatment of chronic pouchitis.\n\nGuselkumab, an interleukin-23 (IL-23) p19 subunit antagonist monoclonal antibody, is proven to be efficacious in patients with moderately-to-severely active UC. Efficacy of guselkumab in treating UC has been shown in multiple large clinical trials. However, patients with pouchitis were never the targeted population and were even often excluded from the trials.\n\nPouchitis becomes a chronic problem with a huge impact in the quality of life of these patients. The incidence of pouchitis has been rising in the last decades. This increase might be explained by a change in dietary habits of this population.\n\nThis open label single center trial at UZ Leuven aims to evaluate the efficacy and safety of guselkumab in the treatment of chronic antibiotic refractory pouchitis during a 48-week treatment period, with or without a dietary intervention. Twenty subjects with a proctocolectomy and IPAA for UC who have developed chronic or relapsing pouchitis will be enrolled.",[28],[143,144,145,146],"pouchitis","guselkumab","high fruit diet","low intake of NOVA 4 food products","2026-04-28",{"date":123,"type":33},{"date":150,"type":33},"2026-04-23",{"date":152,"type":22},"2029-05-30",{"name":154,"class":40},"Universitaire Ziekenhuizen KU Leuven",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100582522","phase-4-mirikizumab-in-the-treatment-of-chronic-inflammatory-conditions-of-the-pouch-100582522","NCT06864403","Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch","Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related procedures\n* Age \\>\u002F= 18 and \\\u003C\u002F= 80 years\n* Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:\n\n  * Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after stopping antibiotics, thus necessitating continuous antibiotic therapy to achieve symptom control.\n  * Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with typical symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort).\n  * Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after the final stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch ileum, or the presence of pre-pouch ileitis. Pouch body inflammation (pouchitis) may often coexist in the setting of Crohn's-like disease of the pouch.\n* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown\n* Ability to access internet for electronic database entry\n* Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation.\n\nExclusion Criteria:\n\n* Prior exposure to mirikizumab\n* Known hypersensitivity to mirikizumab or its metabolites\n* Current infection with Clostridioides difficile\n* Known HIV or active Hepatitis B\u002FC\n* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \\\u003C1.5 upper limit of normal can be included)\n* Severe hepatic impairment, defined as Child-Pugh Class C\n* Known decreased kidney function with a glomerular filtration rate \\\u003C45 ml\u002Fmin\u002F1.732\n* History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.\n* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.\n* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.",{"count":162,"type":22},25,[77],"The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:\n\nDoes mirikizumab reduce symptoms of pouch disorders\n\nParticipants will:\n\nTake mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms",[28,166,167],"Pouches, Ileoanal","Pouch, Ileal",[169,170,57,171,172,173],"mirikizumab","Omvoh","IPAA","Crohn's-like disease of the pouch","Ileal Pouch Anal Anastomosis","2026-01-29",{"date":176,"type":33},"2026-01-30",{"date":178,"type":33},"2025-08-12",{"date":180,"type":22},"2027-04",{"name":182,"class":40},"University of North Carolina, Chapel Hill",5,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":211},"100550163","phase-3-a-study-to-learn-about-the-safety-of-vedolizumab-and-how-well-it-works-in-children-and-teenagers-with-active-chronic-pouchitis-100550163","NCT06443502","A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis","An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis","Inclusion Criteria:\n\n1. The participant weighs \\>=10 kg at the time of screening and first dose.\n2. Has active chronic pouchitis, defined by a mPDAI score \\>=5 assessed using the 3-day average of participant-reported clinical symptoms prior to the screening endoscopy (that is \\[ie\\] video pouchoscopy with biopsy) or bowel preparation for the endoscopy and a minimum mPDAI endoscopic subscore of 2 (outside the staple or suture line) and either:\n\n   * \\>=1 previous episodes of pouchitis within 1 year before the screening visit, with symptoms lasting for at least a total of 4 weeks, treated with \\>=2 weeks of antibiotic or other prescription therapy (ie, other antibiotics, probiotics, immunomodulators, or anti-tumor necrosis factor \\[TNFs\\] within 1 year before screening). Or\n   * Have had an inadequate response with, or lost response to, or be intolerant to antibiotic therapy (ie, requiring maintenance antibiotic therapy taken for \\>=4 weeks immediately before the baseline endoscopy visit or not able to receive or continue antibiotic treatment due to intolerance or other contraindication).\n3. The participant is aged 2 to 17 years, inclusive, at the time of screening and first dose.\n4. The participant has a history of proctocolectomy and ileal pouch-anal anastomosis (IPAA) as treatment for ulcerative colitis (UC), Crohn's disease (CD), familial adenomatous polyposis (FAP), or other underlying conditions, such as Hirschsprung's disease, for which construction of a pouch was medically indicated, completed at least 1 year before the screening visit.\n\nExclusion Criteria:\n\nThe exclusion criteria are divided into 3 categories: active chronic pouchitis exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria.\n\nActive Pouchitis Exclusion Criteria:\n\n1. Has symptoms believed to be predominantly due to irritable pouch syndrome.\n2. Has isolated cuffitis.\n3. Is found to have dysplasia at the screening endoscopy.\n4. Has mechanical complications of the pouch (for example \\[e.g.\\] pouch stricture or pouch fistula).\n5. Currently requires or has a planned surgical intervention during the study.\n6. Has a diverting stoma.\n\n   Infectious Disease Exclusion Criteria:\n7. Has evidence of an active infection (e.g. sepsis, cytomegalovirus \\[CMV\\], or listeriosis) during screening.\n8. Had a clinically significant infection (e.g. pneumonia, pyelonephritis, coronavirus disease 2019 \\[COVID-19\\]) within 35 days before first dose of study drug.\n9. Has active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 3 months of screening or during the screening period that is positive, as defined by:\n\n   * A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, or\n   * A TB skin test reaction \\>=5 millimeter (mm). NOTE: If participant have received Bacillus Calmette-Guérin vaccine, then a QuantiFERON TB Gold test should be performed instead of the TB skin test.\n\n   NOTE: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.\n10. Has evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (e.g. HBsAg negative and hepatitis B antibody positive) may, however, be included.\n\n    NOTE: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.\n11. Has chronic hepatitis C virus (HCV) (ie, positive HCV antibody \\[HCVAb\\] and HCV Ribonucleic Acid \\[RNA\\]).\n\n    NOTE: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \\[defined as no evidence of HCV RNA at least 12 weeks before baseline\\]).\n12. Has any identified congenital or acquired immunodeficiency (e.g. common variable immunodeficiency, HIV infection, organ transplantation).\n13. Has positive stool studies for ova and\u002For parasites or stool culture at screening visit.\n14. Has positive Clostridium difficile stool test at screening visit.\n\n    General Exclusion Criteria:\n15. Is taking, has taken, or is required to take any excluded medications.\n16. Has active cerebral\u002Fmeningeal disease, signs\u002Fsymptoms, or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.\n17. Has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.\n18. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematologic, coagulation, immunological, endocrine\u002Fmetabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.","2 Years","17 Years",{"count":194,"type":22},30,[196],"PHASE3","When some people have their large bowel removed, a surgeon can make a \"pouch\" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab.\n\nThis study consists of two parts: Part 1 includes the induction and maintenance periods, and Part 2 includes the continued maintenance period. Participants will receive up to 12 infusions of vedolizumab. In Part 1 of the study, first 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in the maintenance period for Part 1. After completing treatment with vedolizumab in Part 1, participants will visit their clinic for a health check at Week 34.\n\nParticipants who show clinical response at Week 34 will continue to Part 2, receiving vedolizumab every 8 weeks for an additional 40 weeks, starting at Week 38 and ending with the last dose being at Week 78. Final efficacy assessments, including a pouchoscopy will be performed at Week 82.",[28],[200],"Drug Therapy","2025-09-18",{"date":203,"type":33},"2025-09-19",{"date":205,"type":33},"2024-11-19",{"date":207,"type":22},"2029-12-31",{"name":209,"class":210},"Takeda","INDUSTRY",14,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":41},"100502965","early-phase-1-fecal-microbiota-transplant-for-patients-with-chronic-pouchitis-100502965","NCT05829109","Fecal Microbiota Transplant for Patients With Chronic Pouchitis","Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation","Inclusion Criteria:\n\nPatients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as:\n\n* Chronic antibiotic dependent pouchitis:\n* The need for continuous antibiotic therapy (\\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes, OR\n* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months\n* Chronic antibiotic refractory pouchitis:\n* Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics\n* Crohn's disease like pouch inflammation on biologic or small molecule therapy with persistent symptoms:\n* Pre-pouch ileal inflammation, strictures, and\u002For fistulae, AND\n* Active biologic or small molecule therapy, AND\n* Persistent symptoms with mPDAI clinical sub-score ≥ 2\n\nExclusion Criteria:\n\nPatients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:\n\n* Allergy to vancomycin, metronidazole, or ingredients present in the FMT\n* Women who are breastfeeding\n* Women who are pregnant\n* Participants with fever \\> 100.4F\u002F38C or other signs of active illness\n* Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)\n* Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids or any investigational drugs\n* Crohn's disease like pouch inflammation\n* Active enteric infection\n* Isolated cuffitis\n* Clinically significant strictures of the pouch inlet or outlet\n* Participation in a clinical trial in the preceding 30 days\n* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines will put the participant at greater risk from FMT",{"count":220,"type":22},16,[222],"EARLY_PHASE1","The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.",[225,28],"Chronic Pouchitis","2025-07-10",{"date":228,"type":33},"2025-07-15",{"date":230,"type":33},"2024-09-01",{"date":232,"type":22},"2026-12",{"name":39,"class":40},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100540118","phase-4-rifaximin-for-the-secondary-prevention-of-recurrent-pouchitis-100540118","NCT06312683","Rifaximin for the Secondary Prevention of Recurrent Pouchitis","Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related procedures\n* Age \\> 18 and \\\u003C75 years\n* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage Ileal pouch anal anastomosis (IPAA) and ileostomy takedown\n* Diagnosis of initial episode of pouchitis within the first 12 months after ileostomy takedown\u002Ffinal stage of IPAA surgery\n\nExclusion Criteria:\n\n* Known hypersensitivity to rifaximin or its metabolites\n* Known Crohn's disease\n* History of perianal fistula\n* Known incontinence due to anal sphincter dysfunction\n* Known irritable pouch syndrome\n* Active ongoing pelvic infection\u002Fsepsis at baseline visit\n* New onset of high bowel frequency in the setting of acute pouchitis in the first 4 weeks after IPAA\n* Known Clostridoides difficile infection\n* Need for antibiotic long-term therapy (e.g. doxycycline for acne)\n* Known active Hepatitis B, C, HIV\n* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \\\u003C1.5 upper limit of normal can be included)\n* Severe hepatic impairment, defined as Child-Pugh Class C\n* Concomitant use of p-glycoprotein (P-gp) inhibitors (e.g. cyclosporine)\n* Known decreased kidney function with a glomerular filtration rate \\\u003C60 ml\u002Fmin\u002F1.732\n* Fecal microbiota transplantation within 16 weeks before ileostomy takedown\n* History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to Screening and no recurrence.\n* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. Women of child-bearing potential must have a negative urine pregnancy test prior to drug being dispensed.\n* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.\n* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.","74 Years",{"count":220,"type":22},[77],"Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis.",[28],[246],"Recurrent pouchitis","2025-07-08",{"date":249,"type":33},"2025-07-11",{"date":251,"type":33},"2024-07-01",{"date":253,"type":22},"2026-07",{"name":182,"class":40},2,{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100582271","exploring-the-influence-of-trptophan-on-the-treatment-of-pouchitis-100582271","NCT06861140","Exploring the Influence of Trptophan on the Treatment of Pouchitis","Untersuchung Des Einflusses Einer Tryptophanreichen Diät Auf Das Therapeutische Potential Von Probiotika Nach Antibiotischer Therapie Bei Chronischer Pouchitis (Try Pro Pouch). Eine Prospektive Randomisierte Kontrollierte Doppelblinde Interventionsstudie","TryProPouch","Inclusion Criteria:\n\n* Pouchitis (PDAI \\>= 7)\n* indication for the application of antibiotics and probiotics\n* Age \\>=18 years\n* Informed consent\n\nExclusion Criteria:\n\n* major surgery planned druing the intervention\n* high risk for malnutrition (NRS 2002 \\>=3\u002F BMI \\\u003C18,5 kg\u002Fm\\^2)",{"count":52,"type":22},[266],"NA","Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.",[28],[28,270,271,272,273],"Antibiotics","Probiotics","Tryptophan","Metabolites","2025-03-01",{"date":276,"type":33},"2025-03-06",{"date":278,"type":22},"2025-04-01",{"date":280,"type":22},"2027-04-30",{"name":282,"class":40},"Universitätsklinikum Hamburg-Eppendorf",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":41},"100327611","phase-2-fecal-microbiota-transplantation-for-pouchitis-100327611","NCT03545386","Fecal Microbiota Transplantation for Pouchitis","Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis","Inclusion Criteria:\n\n1. Patients aged 18 or over\n2. Active pouchitis defined as PDAI of 7-18 points\n3. Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance\n\nExclusion Criteria:\n\n1. Participating in another clinical trial\n2. Unable to give informed consent\n3. Severe comorbid medical illness\n4. Concomitant Clostridium difficile infection","99 Years",{"count":292,"type":22},34,[25],"This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.",[28],{"date":297,"type":33},"2024-11-20",{"date":299,"type":33},"2019-04-17",{"date":301,"type":22},"2025-09-30",{"name":303,"class":40},"McMaster University"]