[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bowel-diseases-inflammatory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bowel-diseases-inflammatory":30},{"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":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100626336","phase-3-use-of-dexmedetomidine-to-improve-pain-control-and-recovery-after-laparocopic-assisted-bowel-surgery-in-adults-100626336","NCT07434310","Use of Dexmedetomidine to Improve Pain Control and Recovery After Laparocopic-Assisted Bowel Surgery in Adults","Postoperative Dexmedetomidine (PODEX) for Enhanced Recovery in Bowel Surgery: A Double-Blinded, Randomized Controlled Trial","PODEX","Inclusion Criteria:\n\n1. Adults aged 18-70 years.\n2. Undergoing elective or semi-elective laparoscopic-assisted bowel surgery (e.g., bowel resection, colectomy, ileostomy reversal).\n3. ASA physical status I-III.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to dexmedetomidine.\n2. Cardiac impairment defined as:\n\n   1. Moderate or severe systolic dysfunction\n   2. Moderate or severe valvulopathy (as per American Society of Echocardiography criteria)\n   3. Significant bradycardia (baseline heart rate \\\u003C 60) or\n   4. Heart block without a pacemaker.\n3. Active infection or sepsis at the time of surgery.\n4. Use of medications with significant interactions with dexmedetomidine (e.g., MAO inhibitors).\n5. Pregnant or breastfeeding individuals.\n6. Current opioid use (\\> 30 mg daily oral morphine equivalent) or history of opioid use disorder.\n7. Current clonidine use.\n8. Patients undergoing thoracic epidurals.\n9. Patients with liver impairment with a Child-Pugh class of B (moderate) or C (severe).","70 Years",{"count":58,"type":22},70,[60],"PHASE3","This study is testing whether continuing a medication called dexmedetomidine after surgery can improve quality of recovery for adults undergoing laparoscopic-assisted bowel surgery.\n\nAfter bowel surgery, many patients experience significant pain and slow recovery. Pain is often treated with strong opioid medications, which can cause side effects such as nausea, vomiting, constipation, sedation, and delayed return of bowel function. Other pain control options, such as epidurals or nerve blocks, are not always suitable for laparoscopic bowel surgery and may have their own risks or limitations. As a result, there are few effective non-opioid options for managing pain in this patient group.\n\nDexmedetomidine is a medication that can reduce pain and the need for opioids while providing sedation without affecting breathing. It is commonly used during surgery, but it is not known whether continuing dexmedetomidine after surgery improves pain control and overall recovery in bowel surgery patients. This study aims to answer that question.\n\nThe PODEX study is a single-centre, randomized, double-blind, placebo-controlled trial. Adults aged 18 to 70 years who are having elective or semi-elective laparoscopic-assisted bowel surgery will be invited to take part. About 94 participants will be enrolled. After surgery, participants will be randomly assigned (by chance) to receive either a continuous dexmedetomidine infusion or a placebo (salt water) infusion for 48 hours. Neither the participants nor the study team will know which treatment a participant receives during the study. All participants will receive the same standard surgical care, anesthesia, and postoperative pain medications.\n\nThe main outcome of the study is quality of recovery, measured 48 hours after surgery using a short questionnaire (QoR-15) that asks about comfort, pain, physical well-being, and emotional state. Other outcomes include recovery scores at additional time points, pain levels, opioid use, nausea and vomiting, return of bowel function, length of hospital stay, and side effects such as low blood pressure or slow heart rate.\n\nThe results of this study may help determine whether postoperative dexmedetomidine is a safe and effective way to improve recovery and reduce opioid use after bowel surgery.",[30,63,64],"Bowel Surgery","Laparoscopic Abdominal Surgeries",[66,67,68,69,70,71,72,73,74,75],"bowel surgery","pain after surgery","quality of recovery","recovery after surgery","laparoscopic surgery","postoperative pain","bowel surgery pain","laparoscopy surgery pain","abdominal pain","laparoscopy","2026-06-19",{"date":78,"type":39},"2026-06-24",{"date":80,"type":22},"2026-07-01",{"date":82,"type":22},"2027-12-01",{"name":84,"class":46},"Dr. Naveed Siddiqui",1]