[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maia Kayal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"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":50,"type":22},16,[52],"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.",[55,28],"Chronic Pouchitis","2025-07-10",{"date":58,"type":33},"2025-07-15",{"date":60,"type":33},"2024-09-01",{"date":62,"type":22},"2026-12",{"name":39,"class":40},""]