[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pouches-ileoanal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pouches-ileoanal":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,80],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100651116","tirzepatide-for-ileal-pouch-anal-anastomosis-ipaa-and-chronic-high-bowel-frequency-i8f-ns-x008-100651116",false,"NCT07756359","Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)","Efficacy of the Dual GIP - GLP-1 Receptor Agonist Tirzepatide in Patients With an Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)","PROP-ZEP","Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related procedures\n* Age \\> 18 and \\\u003C80 years\n* Patients with an IPAA and bowel frequency \\> 8 bowel movements in 24 hours on at least 4 of 7 days\u002Fweek (and\u002For an average of \\>8 bowel movements in the 7 days preceding enrollment)\n\n  * Patients must have demonstrated high bowel frequency despite adequate therapy for high bowel frequency with loperamide 2 mg orally every 6 hours as needed (at least 3 doses daily) and\u002For diphenoxylate\u002Fatropine 2 mg orally every 6 hours as needed (at least 3 doses daily) or proven intolerance to these anti-diarrheal medications.\n  * Among patients with inflammatory conditions of the pouch, high bowel frequency must be demonstrated despite adequate therapy for intermittent pouchitis, chronic pouchitis, or Crohn's like disease of the pouch. Adequate therapy is required to ensure significant pouch inflammation is not a driver of high bowel frequency (described in Exclusion Criteria).\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\nExclusion Criteria:\n\n* Prior exposure to tirzepatide or other GLP-1RA\n* BMI \\\u003C20 at the time of study screening\n* Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2\n* Known hypersensitivity to tirzepatide or its metabolites\n* Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4\n* Known stricture of the ileo-anal anastomosis or afferent limb stricture\n* New onset of high bowel frequency in the setting of acute pouchitis\n* Final stage of IPAA surgery \\\u003C 6 months prior to enrollment\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 clinically significant chronic nausea and\u002For vomiting in the past\n* Known diagnosis of type 1 or type 2 diabetes\n* Known decreased kidney function with a glomerular filtration rate \\\u003C30 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* New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event\n* Prior history of pancreatitis\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.","ALL","18 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy.\n\nThe main question it aims to answer is:\n\nDoes Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch\n\nParticipants will:\n\nVisit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.",[28,29,30],"Pouch, Ileal","Pouches, Ileoanal","Bowel Diseases, Inflammatory",[32,33,34],"High Bowel Frequency","IPAA","ileal pouch-anal anastomosis","NOT_YET_RECRUITING","2026-08-04",{"date":38,"type":39},"2026-08-10","ACTUAL",{"date":41,"type":22},"2026-09",{"date":43,"type":22},"2027-09",{"name":45,"class":46},"University of North Carolina, Chapel Hill","OTHER",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100648675","evaluation-of-the-ileo-anal-pouch-in-fap-endopol-100648675","NCT07726771","Evaluation of the Ileo-anal Pouch in FAP (ENDOPOL)","ENDOPOL: Dye chromoENDOscopy Versus Virtual Chromoendoscopy for Assessment of the Ileo-anal Pouch in Patients With Familial Adenomatous POLyposis: a Randomized Controlled Trial","ENDOPOL","Inclusion Criteria:\n\nALL of the following:\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years\n\nExclusion Criteria:\n\nANY of the following\n\n1. Diagnosis of FAP i.e., at least one of following:\n\n   * Genetic diagnosis: proven APC germline mutation OR\n   * Clinical diagnosis: \\>100 colorectal adenomas in combination with a positive family history of FAP\n2. Have an ileal-pouch anal anastomosis (IPAA), either after primary proctocolectomy or secondary proctectomy after initial colectomy and ileorectal or ileosigmoidal anastomosis (IRA\u002FISA)\n3. Age ≥ 18 years",{"count":57,"type":22},50,[59],"NA","This international, multi-centre randomised controlled trial will compare dye-based chromoendoscopy with virtual chromoendoscopy, using NBI\u002FBLI, for adenoma detection during routine surveillance pouchoscopy in adults with familial adenomatous polyposis (FAP) and an ileal pouch-anal anastomosis (IPAA). The estimated study duration is 2 years. Participants will undergo their usual scheduled pouchoscopy, performed by endoscopists experienced in FAP. Before the procedure, they will be randomised 1:1 to dye-based or virtual chromoendoscopy. Adenomas requiring endoscopic treatment will be removed during the same procedure according to standard practice.\n\nTo our knowledge, no previous study has directly compared these techniques in this setting. Current guidelines recommend surveillance in patients with FAP and a pouch and permit dye-spray chromoendoscopy, but do not specify whether dye-based or virtual chromoendoscopy should be preferred. Practice varies between centres: virtual chromoendoscopy is commonly used at St Mark's Hospital, while some European centres primarily use dye-based chromoendoscopy. This study therefore aims to standardise practice and generate evidence to inform future surveillance strategies.\n\nEligible patients will be adults aged ≥18 years with FAP, defined by a proven APC germline mutation or a clinical diagnosis of \\>100 colorectal adenomas with a positive family history, and who have undergone IPAA after primary proctocolectomy or secondary proctectomy following IRA\u002FISA. Patients will be identified through routine endoscopy booking systems. Those who have consented to email communication from the Polyposis Registry team will receive a Participant Information Sheet in advance. They will be approached again on the day of their procedure, given the opportunity to ask questions, and consented before randomisation. Patients who do not consent will undergo their planned pouchoscopy as normal, without study randomisation. Patients lacking capacity to consent will not be approached.\n\nRandomisation will be performed using an independent computer-generated programme within Castor EDC, with allocation in a 1:1 ratio. Block randomisation will ensure balanced distribution between arms within each centre, and stratification by centre will account for differences in patient characteristics and local practice. Blinding is not feasible because dye-based and virtual chromoendoscopy have visually distinct appearances.\n\nDuring pouchoscopy, the pre-pouch ileum, pouch body and rectal cuff will be carefully inspected. In the dye-based arm, indigo carmine will be applied using a spray catheter before withdrawal and mucosal inspection. In the virtual chromoendoscopy arm, inspection will be performed using NBI\u002FBLI according to local platform availability. The endoscope will be advanced to the pre-pouch ileum, followed by systematic withdrawal and spiral mucosal inspection. Lesions will be documented by size and location, including pouch body and rectal remnant\u002Frectal cuff, using a polyp burden scoring table. Retroflexion will be performed to assess the rectal cuff. Polyp size will be estimated in millimetres, supported where appropriate by biopsy forceps of known size. Adenomas will be resected using standard polypectomy techniques where indicated, including polyps \\>5 mm in the pouch body, \\>2 mm in the rectal cuff, or lesions suspicious for high-grade dysplasia or early cancer.\n\nBecause assessment of small polyps can vary between endoscopists, particularly for lesions \\\u003C5 mm, endoscopic images will be used to assess inter-rater and intra-rater reliability for polyp burden and size. If reliability is acceptable, smaller polyps will be included and reported.\n\nQuality parameters will be collected for each procedure, including adjusted Boston Bowel Preparation Scale assessment for the pouch and total procedural time. Procedural time will include scope introduction, irrigation, dye application where applicable, withdrawal and inspection, retroflexion, and removal and retrieval of polyps.\n\nPost-procedure follow-up will follow routine care. Patients will be asked to monitor for adverse events after pouchoscopy and contact the hospital if needed. Future surveillance will be scheduled according to each centre's usual policy.\n\nStudy data will be held in routine hospital systems accessible to the patient's usual clinical team and in a study file. Participants will be assigned a study number. No identifiable patient information will leave the Trust or be accessible to anyone outside the usual care team. Anonymised data will be entered into Castor EDC. Pseudonymised data will be transferred to the central study team at Amsterdam University Medical Center under an existing data transfer agreement for pooled analysis.\n\nThe study does not expose participants to risks beyond routine surveillance pouchoscopy. There is no direct individual benefit but findings may benefit future patients with FAP and families by improving evidence.",[62,29],"Familial Adenomatous Polyposis (FAP)",[64,65,66,67,68],"FAP","Endoscopy","Chromoendoscopy","Dye spray","Pouch","RECRUITING","2026-07-21",{"date":72,"type":39},"2026-07-24",{"date":74,"type":39},"2026-07-09",{"date":76,"type":22},"2031-07-09",{"name":78,"class":46},"London North West Healthcare NHS Trust",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"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":87,"type":22},25,[25],"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",[91,29,28],"Pouchitis",[93,94,95,33,96,97],"mirikizumab","Omvoh","chronic pouchitis","Crohn's-like disease of the pouch","Ileal Pouch Anal Anastomosis","2026-01-29",{"date":100,"type":39},"2026-01-30",{"date":102,"type":39},"2025-08-12",{"date":104,"type":22},"2027-04",{"name":45,"class":46}]