[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632959":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":19,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":19,"enrollmentInfo":40,"targetDuration":19,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":19,"overallStatus":49,"whyStopped":19,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":19},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"On-Off Cycling Intervention","EXPERIMENTAL","1 week standard diet, followed by\n\n1 week high-protein, high-fiber diet, followed by\n\n1 week standard diet, followed by\n\n1 week high-protein, high-fiber diet",[13],"Other: High Protein, High Fiber (HPHF) Diet",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"High Protein, High Fiber (HPHF) Diet","The HPHF diet is a diet designed to maximize the intake of proteins and fermentable dietary fibers. Frozen meals are provided to participants weekly and consumed over two non-consecutive 7-day periods.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Levi Teigen","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Lulu Chen","CONTACT","612-301-8294","chen8124@umn.edu",{"type":31,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100632959","microbiome-targeted-diet-therapy-in-ulcerative-colitis-100632959",false,"NCT07520461","Microbiome-targeted Diet Therapy in Ulcerative Colitis","Inclusion Criteria:\n\n* Ability and willingness to provide informed consent\n* Age at least 18 years old\n* Diagnosis of UC based on clinical and endoscopic criteria\n* UC duration of at least 3 months\n* Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization\n* On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).\n\n  1. ≥4 weeks if no medication, 5-ASA\n  2. ≥8 wk for immunomodulatory therapy\n  3. ≥12 wk for biologics\n* Ability to comply with study requirements in the opinion of the primary investigator\n\nExclusion Criteria:\n\n* Moderate or severe UC as defined by UCEIS ≥5\n* History of stomach surgery or bowel resection\n* Antibiotic use within 3 months\n* Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)\n* Pregnancy or breastfeeding\n* History of anaphylactic food allergies\n* Intolerance of high dietary fiber content\n* Ongoing alcohol or drug abuse\n* Habitual vegan diet pattern\n* Insufficient freezer space to accommodate meal delivery","ALL","18 Years",{"count":41,"type":42},40,"ESTIMATED","INTERVENTIONAL",[45],"NA","The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.",[48],"Ulcerative Colitis","NOT_YET_RECRUITING","2026-08-03",{"date":52,"type":53},"2026-08-05","ACTUAL",{"date":55,"type":42},"2026-09-07",{"date":57,"type":42},"2029-06-01",{"name":5,"class":6}]