Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852587
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-05-02
Brief Title:
Xylitol Use for Decolonization of C Difficile in Patients With IBD
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Xylitol Use for Decolonization of C Difficile in Patients With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 111 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
Detailed Description:
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
Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Womens Hospital or clinic appointment at the Crohns 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
Participants 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
Participants who are found to be colonized will be randomized 111 to either placebo or one of two dosing groups of xylitol The dose A treatment arm will receive 75 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
The 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
Stool samples for biomarker assessments and C difficile testing will be collected at scheduled trial visits per Schedule of Assessments
Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Womens Hospital or clinic appointment at the Crohns 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
Participants 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
Participants who are found to be colonized will be randomized 111 to either placebo or one of two dosing groups of xylitol The dose A treatment arm will receive 75 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
The 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
Stool samples for biomarker assessments and C difficile testing will be collected at scheduled trial visits per Schedule of Assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None