[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504765":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":68,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":30,"enrollmentInfo":80,"targetDuration":30,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":93,"whyStopped":30,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose A of Xylitol","EXPERIMENTAL","Patients in this arm will be receiving 7.5g\u002Fday of Xylitol over a 4 week period.",[13],"Drug: Xylitol",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose B of Xylitol","Patients in this are will be receiving 15g\u002Fday of Xylitol over a 4 week period.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Patients in this arm will be receiving placebo over a 4 week period.",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Xylitol","Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Xylitol is also an FDA approved as a food additive. Xylitol will be used as a treatment for the decolonization of C. difficile and will be given in gel capsules. The xylitol provided will be prepared by the BWH investigational drug service and ordered from MEDISCA suppliers. It will be 100% pure. Xylitol has a distinct taste and therefore it will be administered in gel capsules as opposed to an oral solution to maintain blinding.",[9,15],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.",[19],[35],{"name":36,"affiliation":5,"role":37},"Jessica R Allegretti, MD","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Heidy Cabral","CONTACT","6175257322","hjcabral@bwh.harvard.edu",{"name":45,"role":41,"phone":46,"phoneExt":30,"email":47},"Jessica Allegretti, MD","6177326389","jallegretti@bwh.harvard.edu",[49],{"facility":5,"status":30,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Boston","Massachusetts","02115","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-71.05977,42.35843,{"lat":59,"lon":58},[62,66],{"name":63,"role":41,"phone":64,"phoneExt":30,"email":65},"Jessica Allegretti, MD, MPH","617-732-6389","jallegretti@partners.org",{"name":40,"role":41,"phone":67,"phoneExt":30,"email":43},"617-525-7322",{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jessica Ravikoff Allegretti","Director, Crohn's and Colitis Center","100504765","phase-1-xylitol-use-for-decolonization-of-c-difficile-in-patients-with-ibd-100504765",false,"NCT05852587","Xylitol Use for Decolonization of C. Difficile in Patients With IBD","Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Male or female ≥ 18 years of age\n3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)\n4. Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)\n5. Presenting for outpatient colonoscopy or clinic appointment for any indication\n\nExclusion Criteria:\n\n1. Unable to provide consent\n2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)\n3. Unable to complete study procedures\n4. Chronic use of antibiotics\n5. Inability or unwillingness to swallow capsules\n6. Allergy to xylitol\n7. Stool positive for Listeria monocytogenes","ALL","18 Years",{"count":81,"type":82},99,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.",[88,89],"Inflammatory Bowel Diseases","Clostridioides Difficile Infection",[91,92],"Crohn's Disease","Ulcerative colitis","NOT_YET_RECRUITING","2026-02-24",{"date":96,"type":97},"2026-02-25","ACTUAL",{"date":99,"type":82},"2026-08-01",{"date":101,"type":82},"2033-01-01",{"name":5,"class":6},1]