Clinical trial NCT05852587: Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Official title: Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Inflammatory Bowel Diseases
Clostridioides Difficile Infection
Keywords: Crohn's Disease
Ulcerative colitis
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

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 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Male or female ≥ 18 years of age
3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
4. Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
5. Presenting for outpatient colonoscopy or clinic appointment for any indication

Exclusion Criteria:

1. Unable to provide consent
2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
3. Unable to complete study procedures
4. Chronic use of antibiotics
5. Inability or unwillingness to swallow capsules
6. Allergy to xylitol
7. Stool positive for Listeria monocytogenes

Primary outcomes:
measure: C.difficile decolonization
timeFrame: 8 weeks
measure: safety and tolerability
timeFrame: 8 weeks
Secondary outcomes:
measure: biomass of C.difficile
timeFrame: 8 weeks
measure: IBD clinical outcomes
timeFrame: 8 weeks
measure: IBD clinical outcomes
timeFrame: 52 weeks
measure: C. difficile infection
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jessica R Allegretti, MD
role: PRINCIPAL_INVESTIGATOR
References: