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Xylitol Use for Decolonization of C. Difficile in Patients With IBD

Primary Purpose

Inflammatory Bowel Diseases, Clostridioides Difficile Infection

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Xylitol
Sucralose
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Crohn's Disease, Ulcerative colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent. Male or female ≥ 18 years of age IBD diagnosis (CD, UC or indeterminant Colitis will be permitted) Presenting for outpatient colonoscopy for any indication Exclusion Criteria: Unable to provide consent Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy) Unable to complete study procedures Chronic use of antibiotics Inability or unwillingness to swallow capsules Allergy to xylitol or sucralose

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylitol

Sucralose

Arm Description

Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.

Patients in this arm will be receiving 250mg/day of sucralose over a 4 week period.

Outcomes

Primary Outcome Measures

C.difficile decolonization
Absence of C. difficile via PCR in week 8 stool sample
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)

Secondary Outcome Measures

biomass of C.difficile
Change in biomass of C. difficile
IBD clinical outcomes
Clinical Remission: SCCAI score less than 3 & HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points
IBD clinical outcomes
Clinical Remission: SCCAI score less than 3 & HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points
C. difficile infection
Incidence of patients developing CDI

Full Information

First Posted
May 2, 2023
Last Updated
September 5, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05852587
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2024 (Anticipated)
Primary Completion Date
May 1, 2030 (Anticipated)
Study Completion Date
May 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized placebo controlled study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 72 patients who meet eligibility criteria will be randomized 1:1 to either the xylitol or sucralose (placebo) arm. Both arms will receive a dose comprising five capsules BID 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 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 (regardless of disease activity) who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital will be eligible for enrollment. Participants will be screened during colonoscopy for C. difficile colonization via colonic wash sampling. Participants who meet eligibility criteria will be randomized 1:1 to either placebo or xylitol. The treatment arm will receive BID dosing of 7.5 grams via gel capsule for 4 weeks. The placebo arm will receive sucralose at BID dosing of 250 mg via gel capsule for 4 weeks. Participants will end dosing at week 4 but monitoring will continue to week 8. Both participants and study team will be blinded to treatment arm allocation. Participants will be assessed through week 8 for the primary outcome, decolonization. Safety and tolerability outcomes will be assessed through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI will be evaluated at week 8 and week 52. Participants will also be followed through week 52 for long-term safety, efficacy, and clinical outcomes. Disease activity and symptoms will be recorded from time of informed consent through to 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. The primary outcome, decolonization of C. Difficile at week 8, will be confirmed via stool sampling. Additional C. difficile testing will be done at week 26 and week 52. The study will prospectively enroll approximately 56 adult participants at a single center. Participants that experience intolerable adverse events will be withdrawn from the study and will be considered treatment failures. Data from these patients will be carried forward from last evaluable assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Clostridioides Difficile Infection
Keywords
Crohn's Disease, Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xylitol
Arm Type
Experimental
Arm Description
Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
Arm Title
Sucralose
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will be receiving 250mg/day of sucralose over a 4 week period.
Intervention Type
Drug
Intervention Name(s)
Xylitol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sucralose
Intervention Description
The placebo in this trial will be sucralose. Sucralose is alternate SA that is poorly absorbed and non-microbially metabolized by bacteria in the microbiome including C. difficile. Because this is a double-blind, controlled trial, the control will be presented in capsules that are identical in size, smell, texture, and appearance to those of the xylitol capsules. These will be produced by the BWH investigational drug service. Sucralose will be ordered from MEDISCA as well and will be 100% pure.
Primary Outcome Measure Information:
Title
C.difficile decolonization
Description
Absence of C. difficile via PCR in week 8 stool sample
Time Frame
8 weeks
Title
safety and tolerability
Description
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
biomass of C.difficile
Description
Change in biomass of C. difficile
Time Frame
8 weeks
Title
IBD clinical outcomes
Description
Clinical Remission: SCCAI score less than 3 & HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points
Time Frame
8 weeks
Title
IBD clinical outcomes
Description
Clinical Remission: SCCAI score less than 3 & HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points
Time Frame
52 weeks
Title
C. difficile infection
Description
Incidence of patients developing CDI
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent. Male or female ≥ 18 years of age IBD diagnosis (CD, UC or indeterminant Colitis will be permitted) Presenting for outpatient colonoscopy for any indication Exclusion Criteria: Unable to provide consent Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy) Unable to complete study procedures Chronic use of antibiotics Inability or unwillingness to swallow capsules Allergy to xylitol or sucralose
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma McClure
Phone
6177329223
Email
elmcclure@bwh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Allegretti, MD
Phone
6177326389
Email
jallegretti@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica R Allegretti, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Allegretti, MD, MPH
Phone
617-732-6389
Email
jallegretti@partners.org
First Name & Middle Initial & Last Name & Degree
Emma McClure
Phone
617-732-9223
Email
elmcclure@bwh.harvard.edu

12. IPD Sharing Statement

Learn more about this trial

Xylitol Use for Decolonization of C. Difficile in Patients With IBD

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