[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500071":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":40,"locations":46,"responsibleParty":141,"collaborators":40,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":40,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":66,"whyStopped":40,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Wolfson Medical Center","OTHER_GOV",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Ulcerative colitis Exclusion Diet + Partial enteral nutrition","EXPERIMENTAL","Participants in Group 1 will receive the UCED combined with partial enteral nutrition (PEN) using a novel nutritional formula for 6 weeks (diet phase 1) that will add to oral budesonide 9 mg topical therapy for 6 weeks and will follow diet + PEN (phase 2: wk6-wk12) and diet phase 3 for 24 weeks.",[13,14,15],"Other: Ulcerative colitis Exclusion Diet","Other: Partial enteral nutrition (PEN)","Drug: Oral Budesonide",{"label":17,"type":18,"description":19,"interventionNames":20},"Free diet","ACTIVE_COMPARATOR","Participants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention",[21,15],"Other: free diet",[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"OTHER","Ulcerative colitis Exclusion Diet","a limited whole food diet (UCED)",[9],[29],"UCED",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Partial enteral nutrition (PEN)","The diet will be supplemented by 3 glasses a day (750 m\"l) of the formula developed for UC using the UCED principles.",[9],[35],"UC nutritional formula, Nestle",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"free diet","oral Budeosnide for 6 weeks + free diet",[17],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":40},"DRUG","Oral Budesonide","Oral Budesonide 9 mg",[17,9],[47,65,82,96,112,126],{"facility":48,"status":49,"city":50,"state":40,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Emek Medical Center","NOT_YET_RECRUITING","Afula","1834111","Israel","IL",{"type":55,"coordinates":56},"Point",[57,58],35.2892,32.60907,{"lat":58,"lon":57},[61],{"name":62,"role":63,"phone":40,"phoneExt":40,"email":64},"Eran Zittan, MD","CONTACT","eranzittan@clalit.org.il",{"facility":5,"status":66,"city":67,"state":40,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"RECRUITING","Holon","58100",{"type":55,"coordinates":70},[71,72],34.77918,32.01034,{"lat":72,"lon":71},[75,79],{"name":76,"role":63,"phone":77,"phoneExt":40,"email":78},"Eran Israeli, Professor","972-52-5912199","erani@wmc.gov.il",{"name":80,"role":63,"phone":77,"phoneExt":40,"email":81},"Chen Sarbagili, RD","ibd.chen@gmail.com",{"facility":83,"status":66,"city":84,"state":40,"zip":85,"country":52,"countryCode":53,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Tel Aviv Sourasky Medical Center","Tel Aviv","6423906",{"type":55,"coordinates":87},[88,89],34.78057,32.08088,{"lat":89,"lon":88},[92],{"name":93,"role":63,"phone":94,"phoneExt":40,"email":95},"Nitsan Maharshak, Professor","972-52-7360384","nitsanm@tlvmc.gov.il",{"facility":97,"status":49,"city":98,"state":40,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth","Roma","00168","Italy","IT",{"type":55,"coordinates":103},[104,105],11.10642,44.99364,{"lat":105,"lon":104},[108],{"name":109,"role":63,"phone":110,"phoneExt":40,"email":111},"Franco Scaldaferri, MD, PhD","+390630155923","francoscaldaferri@gmail.com",{"facility":113,"status":49,"city":114,"state":40,"zip":40,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Radboud University Medical Center (Radboudumc)","Nijmegen","Netherlands","NL",{"type":55,"coordinates":118},[119,120],5.85278,51.8425,{"lat":120,"lon":119},[123],{"name":124,"role":63,"phone":40,"phoneExt":40,"email":125},"Marjolijn Duijvestein, MD, PhD","marjolijn.Duijvestein@radboudumc.nl",{"facility":127,"status":66,"city":128,"state":40,"zip":40,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Kantonsspital St. Gallen","Sankt Gallen","Switzerland","CH",{"type":55,"coordinates":132},[133,134],9.37477,47.42391,{"lat":134,"lon":133},[137],{"name":138,"role":63,"phone":139,"phoneExt":40,"email":140},"Claudia Krieger-Grübel, MD","+417977390545","Claudia.Krieger-Gruebel@kssg.ch",{"type":142,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100500071","combination-of-diet-and-oral-budesonide-for-ulcerative-colitis-100500071",false,"NCT05791487","Combination of Diet and Oral Budesonide for Ulcerative Colitis","Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial","ReDUCE","Inclusion Criteria:\n\n* Informed consent\n* Established diagnosis of UC with mild to moderate active disease, 5 ≤ SCCAI ≤ 10\n* Age: 17-65 years (inclusive)\n* Extent E1-E3 by the Montreal classification\n* Active colitis in the rectum or sigmoid colon on sigmoidoscopy\n* Stable medication use of oral 5ASA for at least 8 weeks, thiopurines, vedolizumabs, Ustekinumab or tofacitinib for at least 12 weeks\n\nExclusion Criteria:\n\n* Severe colitis (SCCAI\\>10) hospitalization for acute severe colitis (ASC) in the previous 6 months\n* Use of steroids in the previous 3 months\n* Patients treated with Anti-TNF currently or in patients who had previously failed or lost response to anti TNF\n* Vegans (vegetarians may enroll)\n* Pregnancy\n* Inability use of budesonide due to severe adverse events\n* Extraintestinal manifestations such as arthritis, spondyloarthropathy or uveitis\n* Presence of baseline hypoalbuminemia\n* Fever \\>38°C\n* Evidence for Clostridioides difficile infection\n* Renal failure\n* Hepatitis or PSC (Primary Sclerosing Cholangitis)\n* Active malignancy (excluding skin BCC).","ALL","17 Years","65 Years",{"count":155,"type":156},90,"ESTIMATED","INTERVENTIONAL",[159],"NA","The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula.\n\nThe investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.",[162,163,164],"Ulcerative Colitis","Ulcerative Colitis Chronic Mild","Ulcerative Colitis Chronic Moderate",[166,167,168,169],"Ulcerative colitis","Diet","Partial enteral nutrition","Microbiome","2024-05-21",{"date":172,"type":173},"2024-05-23","ACTUAL",{"date":175,"type":173},"2023-12-01",{"date":177,"type":156},"2026-09-01",{"name":5,"class":6},6]