Inflammatory Bowel Disease (IBD)Early Phase 1NCT06799039
Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
A Early Phase 1 study testing Xylitol in people with Inflammatory Bowel Disease (IBD) and Clostridioides Difficile Infection, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Clostridioides Difficile Infection
- What is being tested?
- Xylitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2031
- Phase
- Early 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 ≤ 4; Partial Mayo score ≤ 4)
- Presenting for outpatient colonoscopy or clinic appointment
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.
- Currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Allegretti, MD MPH contact
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Heidy Cabral, 617-525-7322, hjcabral@bwh.harvard.edu
About this study
This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.
Read the detailed description
Participants with confirmed IBD diagnosis 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 for C. difficile colonization via colonic wash sampling during colonoscopy. Participants may only have inactive or mild IBD at the time of the colonoscopy to be eligible.
Eligible participants will be initially enrolled in the observational cohort until there are 39 subjects enrolled. Participants in the observational cohort will be assessed at Week 1, 4 and 8, following confirmation of colonization. Participants will only be assessed for stool sample testing, IBD scoring and occurrence of CDI.
The subsequent participants who meet eligibility criteria will be enrolled into one of five consecutively increasing dosing groups of xylitol. The dose A treatment arm will receive a daily dose of 1 gram of xylitol for 7 days. The dose B treatment arm will receive a daily dose of 2 grams of xylitol for 7 days. The dose C treatment group will receive a daily dose of 5 grams of xylitol for 7 days. The dose D treatment group will receive a daily dose of 7 grams of xylitol for 7 days. The dose E treatment group will receive a daily dose of 9 grams of xylitol for 7 days. Participants will end dosing at day 7 but monitoring will continue through to week 8.
Participants in the will be assessed through week 8 for the primary outcome, determining the maximum tolerated dosage of xylitol. C. difficile decolonization will be assessed through week 8. Participants will also receive weekly phone call for assessment of symptoms and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI will be evaluated at week 8, and week 26. Participants will also be followed through week 26 for long-term safety, efficacy, and clinical outcomes. Disease activity and symptoms will be recorded from informed consent through the week 26 trial visit.
The primary outcome, determining the maximum tolerated dose of xylitol at week 8 will be confirmed via adverse event reporting. Additional C. difficile testing will be done at week 26.
The study will prospectively enroll between 15 and 30 adult participants at a single center. Participants that experience intolerable adverse events will be withdrawn from the study and will be considered treatment failures.
- Being tested
- Xylitol
- Keywords
- C. Difficile, Decolonization, IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Clostridium Infections
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. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g.
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding Cohort | Experimental | One of five consecutively increasing dosing groups of xylitol Receives: Drug: Xylitol |
| Observational Cohort | No intervention | Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of Xylitol
Incidence of Treatment Emergent Adverse Events (TEAEs) through Week 8
Measured: 8 weeks
C. Diff Decolonization
Proportion of patients decolonized of C. difficile at Week 8
Measured: 8 weeks
Secondary outcomes (3)
Biomass of C. Difficile
Change in biomass of C. difficile in patients at Week 8
Measured: 8 weeks
Effect of C. difficile decolonization on Inflammatory Bowel Disease (IBD) clinical outcomes
Change in IBD clinical score at Week 8 and Week 26. IBD clinical scores are used to assess IBD patient symptoms. The assessments are separated between scores for Ulcerative Colitis (UC) and Crohn's Disease (CD). The Harvey Bradshaw Index (HBI) is a clinical assessment for IBD patients with Crohn's disease while Partial Mayo Score is a clinical assessment for Ulcerative Colitis. The scores will be collected at study visit in form of a survey. The HBI score can vary but a score above 8 or 9 is considered severe disease activity. The Partial Mayo Score can range from 0 to 9 and a score above 7 is considered severe disease activity. A decrease in score from baseline to follow-up timepoints is indicative of improved IBD patient symptoms.
Measured: 26 weeks
C. Difficile infection surveillance
Incidence of patients developing C. Difficile Infection through Week 26
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dose Finding
- Masking
- None (open label)
- Enrolment
- 69 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 Allegretti, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799039
- Sponsor's protocol ID
- 2025P000210
- Status last verified
- Dec 2025
- First submitted
- 23 Jan 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06799039
- Acronym / sponsor ID
- 2025P000210
- Keywords
- C. Difficile, Decolonization, IBD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 29 Jan 2025 (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 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.
Detailed description
Participants with confirmed IBD diagnosis 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 for C. difficile colonization via colonic wash sampling during colonoscopy. Participants may only have inactive or mild IBD at the time of the colonoscopy to be eligible.
Eligible participants will be initially enrolled in the observational cohort until there are 39 subjects enrolled. Participants in the observational cohort will be assessed at Week 1, 4 and 8, following confirmation of colonization. Participants will only be assessed for stool sample testing, IBD scoring and occurrence of CDI.
The subsequent participants who meet eligibility criteria will be enrolled into one of five consecutively increasing dosing groups of xylitol. The dose A treatment arm will receive a daily dose of 1 gram of xylitol for 7 days. The dose B treatment arm will receive a daily dose of 2 grams of xylitol for 7 days. The dose C treatment group will receive a daily dose of 5 grams of xylitol for 7 days. The dose D treatment group will receive a daily dose of 7 grams of xylitol for 7 days. The dose E treatment group will receive a daily dose of 9 grams of xylitol for 7 days. Participants will end dosing at day 7 but monitoring will continue through to week 8.
Participants in the will be assessed through week 8 for the primary outcome, determining the maximum tolerated dosage of xylitol. C. difficile decolonization will be assessed through week 8. Participants will also receive weekly phone call for assessment of symptoms and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI will be evaluated at week 8, and week 26. Participants will also be followed through week 26 for long-term safety, efficacy, and clinical outcomes. Disease activity and symptoms will be recorded from informed consent through the week 26 trial visit.
The primary outcome, determining the maximum tolerated dose of xylitol at week 8 will be confirmed via adverse event reporting. Additional C. difficile testing will be done at week 26.
The study will prospectively enroll between 15 and 30 adult participants at a single center. Participants that experience intolerable adverse events will be withdrawn from the study and will be considered treatment failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose Finding
| Arm | Type | Receives |
|---|---|---|
| Dose Finding Cohort | Experimental | Drug: XylitolOne of five consecutively increasing dosing groups of xylitol |
| Observational Cohort | No intervention | –Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring. |
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 ≤ 4; Partial Mayo score ≤ 4)
- Presenting for outpatient colonoscopy or clinic appointment
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. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g. | Drug | Dose Finding Cohort |
Primary outcome
Safety and Efficacy of Xylitol
Time frame: 8 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs) through Week 8
C. Diff Decolonization
Time frame: 8 weeks
Proportion of patients decolonized of C. difficile at Week 8
3 secondary outcomes
Biomass of C. Difficile
Time frame: 8 weeks
Effect of C. difficile decolonization on Inflammatory Bowel Disease (IBD) clinical outcomes
Time frame: 26 weeks
C. Difficile infection surveillance
Time frame: 26 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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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 Allegretti, MD MPH contact
Jessica Allegretti, MD MPH 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 Early Phase 1 study testing Xylitol in people with Inflammatory Bowel Disease (IBD) 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 16 Dec 2025. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 (617-525-7322, hjcabral@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of Xylitol (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 16 Dec 2025.