Inflammatory Bowel DiseasesPhase 1NCT05852587
Xylitol Use for Decolonization of C. Difficile in Patients With IBD
A Phase 1 study testing Xylitol in people with Inflammatory Bowel Diseases and Clostridioides Difficile Infection, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Clostridioides Difficile Infection
- What is being tested?
- Xylitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Jan 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Male or female ≥ 18 years of age
- IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
- Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
- Presenting for outpatient colonoscopy or clinic appointment for any indication
Who cannot join
- 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
- Stool positive for Listeria monocytogenes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Jessica Allegretti, MD, MPH, 617-732-6389, jallegretti@partners.org
Heidy Cabral, 617-525-7322, hjcabral@bwh.harvard.edu
About this study
Official title: Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
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.
Read the 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.
- Being tested
- Xylitol, Placebo
- Keywords
- Crohn's Disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Clostridium Infections, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolDrug
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.
PlaceboDrug
The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.
| Study group | Role | What they receive |
|---|---|---|
| Dose A of Xylitol | Experimental | Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period. Receives: Drug: Xylitol |
| Dose B of Xylitol | Experimental | Patients in this are will be receiving 15g/day of Xylitol over a 4 week period. Receives: Drug: Xylitol |
| Placebo | Placebo comparator | Patients in this arm will be receiving placebo over a 4 week period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C.difficile decolonization
Absence of C. difficile via PCR in week 8 stool sample
Measured: 8 weeks
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)
Measured: 8 weeks
Secondary outcomes (4)
biomass of C.difficile
Change in biomass of C. difficile
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 52 weeks
C. difficile infection
Incidence of patients developing CDI
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Ravikoff Allegretti, Brigham and Women's Hospital
- Investigators
- Jessica R Allegretti, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852587
- Sponsor's protocol ID
- 2023P001327
- Status last verified
- Feb 2026
- First submitted
- 2 May 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05852587
- Acronym / sponsor ID
- 2023P001327
- Keywords
- Crohn's Disease, Ulcerative colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2033 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose A of Xylitol | Experimental | Drug: XylitolPatients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period. |
| Dose B of Xylitol | Experimental | Drug: XylitolPatients in this are will be receiving 15g/day of Xylitol over a 4 week period. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this arm will be receiving placebo over a 4 week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent.
- Male or female ≥ 18 years of age
- IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
- Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
- Presenting for outpatient colonoscopy or clinic appointment for any indication
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XylitolXylitol 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. | Drug | Dose A of Xylitol, Dose B of Xylitol |
| PlaceboThe placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal. | Drug | Placebo |
Primary outcome
C.difficile decolonization
Time frame: 8 weeks
Absence of C. difficile via PCR in week 8 stool sample
safety and tolerability
Time frame: 8 weeks
Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)
4 secondary outcomes
biomass of C.difficile
Time frame: 8 weeks
IBD clinical outcomes
Time frame: 8 weeks
IBD clinical outcomes
Time frame: 52 weeks
C. difficile infection
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica R Allegretti, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xylitol in people with Inflammatory Bowel Diseases and Clostridioides Difficile Infection, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidy Cabral (6175257322, hjcabral@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C.difficile decolonization (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.