[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456075":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":66,"collaborators":17,"id":68,"slug":17,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":17,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":17,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants that experience pediatric ulcerative colitis activity index score \u003C10.","pediatric ulcerative colitis activity index, remission is \\\u003C10, mild disease 10-34, moderate 35-64, severe 65 or greater","12 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin","normalization or at least improvement of inflammatory markers described above",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"open label intervention arm","EXPERIMENTAL","Butyrate enemas will be administered once daily for twelve weeks.",[31],"Drug: Butyrate",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Butyrate","Butyrate enemas will be administered once a day for 12 weeks",[27],[39],"Butyrate enemas",[41],{"name":42,"affiliation":5,"role":43},"Sonia Michail, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":17,"email":48},"CONTACT","3233611353","sonia.michail@hotmail.com",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Los Angeles","California","90027","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-118.24368,34.05223,{"lat":61,"lon":60},[64],{"name":42,"role":46,"phone":65,"phoneExt":17,"email":48},"(323) 361-1353",{"type":43,"investigatorFullName":42,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Principal Investigator","100456075",false,"NCT05218850","The Use of Butyrate Therapy in Pediatric Ulcerative Colitis","Butyrate Therapy in Hispanic Children With Ulcerative Colitis","Inclusion Criteria:\n\n* 7-21 years, mild to moderate ulcerative colitis\n\nExclusion Criteria:\n\n* UC therapy within 4 weeks of study medication initiation\n* infectious colitis, -pregnancy","ALL","7 Years","21 Years",{"count":78,"type":79},10,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.",[85],"Ulcerative Colitis",[87],"ulcerative colitis","2026-06-02",{"date":90,"type":91},"2026-06-04","ACTUAL",{"date":93,"type":91},"2022-06-29",{"date":95,"type":79},"2027-06-30",{"name":5,"class":6},1]