[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05852587":3,"trial-entities:NCT05852587":106,"trial-summary:NCT05852587":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":51,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":93,"overall_officials":100,"references":104,"see_also_links":105},"NCT05852587","2023P001327","Xylitol Use for Decolonization of C. Difficile in Patients With IBD","Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease","NOT_YET_RECRUITING","2033-01-01","2026-02","2026-02-25","2026-08-01","Brigham and Women's Hospital","OTHER",true,"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.","This randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the IBD patient population.\n\nParticipants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital or clinic appointment at the Crohn's and Colitis Center will be eligible for screening. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment.\n\nParticipants may only have inactive or mild IBD based in clinical scores (see inclusion criteria) to be eligible for screening. Risk factors for colonization will be assessed by comparing colonized vs. not colonized patients.\n\nParticipants who are found to be colonized will be randomized 1:1:1 to either placebo or one of two dosing groups of xylitol. The dose A treatment arm will receive 7.5 grams daily of xylitol via gel capsule for 4 weeks. The dose B treatment arm will receive 15 grams daily of xylitol via gel capsule for 4 weeks. The placebo arm will receive identical capsule dosing for 4 weeks. Participants will end dosing at week 4, but monitoring will continue through week 52. Both participants and study team will be blinded to treatment arm allocation.\n\nThe primary endpoints assessed are decolonization at week 8 as well as safety and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI, which will be evaluated at week 8, week 26 and week 52. Disease activity and symptoms will be recorded from informed consent through the week 52 trial visit.\n\nStool samples for biomarker assessments and C. difficile testing will be collected at scheduled trial visits per Schedule of Assessments.",[19,20],"Inflammatory Bowel Diseases","Clostridioides Difficile Infection",[22,23],"Crohn's Disease","Ulcerative colitis","INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},99,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"Dose A of Xylitol","Dose B of Xylitol",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Placebo","The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.",[40],[44,48],{"measure":45,"description":46,"timeFrame":47},"C.difficile decolonization","Absence of C. difficile via PCR in week 8 stool sample","8 weeks",{"measure":49,"description":50,"timeFrame":47},"safety and tolerability","Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)",[52,55,58,60],{"measure":53,"description":54,"timeFrame":47},"biomass of C.difficile","Change in biomass of C. difficile",{"measure":56,"description":57,"timeFrame":47},"IBD clinical outcomes","Clinical Remission: Partial Mayo score less than 1 \\& HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points",{"measure":56,"description":57,"timeFrame":59},"52 weeks",{"measure":61,"description":62,"timeFrame":59},"C. difficile infection","Incidence of patients developing CDI","ALL","18 Years",null,false,{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"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",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":90},"Boston","Massachusetts","02115","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Jessica Allegretti, MD, MPH","CONTACT","617-732-6389","jallegretti@partners.org",{"name":87,"role":83,"phone":88,"email":89},"Heidy Cabral","617-525-7322","hjcabral@bwh.harvard.edu",{"lat":91,"lon":92},42.35843,-71.05977,[94,96],{"name":87,"role":83,"phone":95,"email":89},"6175257322",{"name":97,"role":83,"phone":98,"email":99},"Jessica Allegretti, MD","6177326389","jallegretti@bwh.harvard.edu",[101],{"name":102,"affiliation":13,"role":103},"Jessica R Allegretti, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":112},[108,109,110,111],"Colitis of Indeterminate Type","Crohn Disease","Inflammatory Bowel Disease","Ulcerative Colitis",[],{"nct_id":4,"found":15,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a randomized, placebo-controlled study involving 99 participants. Participants will be assigned by chance to receive one of two doses of xylitol or a placebo, and neither you nor the study team will know which treatment you are receiving.","completed","Xylitol for C. difficile in IBD Patients","This study is looking at whether xylitol, a sugar alcohol, can help clear *Clostridioides difficile* (C. difficile) bacteria from the gut in people with Inflammatory Bowel Disease (IBD). Xylitol is already approved as a food additive. You might be able to join if you are 18 or older, have an IBD diagnosis (Crohn's disease, ulcerative colitis, or indeterminate colitis) that is inactive or mild, and are scheduled for an outpatient colonoscopy or clinic appointment. The study will compare two different doses of xylitol to a placebo (an inactive substance) to see if xylitol can successfully clear C. difficile after 8 weeks, and to check for any side effects. The study aims to enroll 99 participants.","Participants will be monitored for 52 weeks after starting the treatment, even though dosing stops at week 4.",115,"You would take capsules daily for 4 weeks. You will also have C. difficile and microbiome tests at the beginning, at 4 weeks, 8 weeks, 26 weeks, and 52 weeks.","Not stated in the trial record.",[34,40],"v2"]