[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pouch-ileal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pouch-ileal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"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":55,"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",[59,29,28],"Pouchitis",[61,62,63,33,64,65],"mirikizumab","Omvoh","chronic pouchitis","Crohn's-like disease of the pouch","Ileal Pouch Anal Anastomosis","RECRUITING","2026-01-29",{"date":69,"type":39},"2026-01-30",{"date":71,"type":39},"2025-08-12",{"date":73,"type":22},"2027-04",{"name":45,"class":46}]