[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577495":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":52,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Finding Cohort","EXPERIMENTAL","One of five consecutively increasing dosing groups of xylitol",[13],"Drug: Xylitol",{"label":15,"type":16,"description":17,"interventionNames":18},"Observational Cohort","NO_INTERVENTION","Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Xylitol","Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g.",[9],[26],{"name":27,"affiliation":5,"role":28},"Jessica Allegretti, MD MPH","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Heidy Cabral","CONTACT","617-525-7322","hjcabral@bwh.harvard.edu",{"name":27,"role":32,"phone":36,"phoneExt":18,"email":18},"617-732-6389",[38],{"facility":5,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Boston","Massachusetts","02115","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.05977,42.35843,{"lat":48,"lon":47},[51],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},{"type":28,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jessica Ravikoff Allegretti","Jessica R. Allegretti, MD, MPH, FACG, AGAF, Principle Investigator","100577495","early-phase-1-pilot-trial-of-xylitol-for-c-difficile-de-colonization-in-patients-with-inflammatory-bowel-disease-100577495",false,"NCT06799039","Pilot Trial of Xylitol for C. Difficile De-Colonization 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 ≤ 4; Partial Mayo score ≤ 4)\n5. Presenting for outpatient colonoscopy or clinic appointment\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. Currently pregnant or breastfeeding","ALL","18 Years",{"count":64,"type":65},69,"ESTIMATED","INTERVENTIONAL",[68],"EARLY_PHASE1","This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.",[71,72],"Inflammatory Bowel Disease (IBD)","Clostridioides Difficile Infection",[74,75,76],"C. Difficile","Decolonization","IBD","NOT_YET_RECRUITING","2025-12-08",{"date":80,"type":81},"2025-12-16","ACTUAL",{"date":83,"type":65},"2026-09-01",{"date":85,"type":65},"2031-09-01",{"name":5,"class":6},1]