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Not yet recruitingPhase 1

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

Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 52 visits
  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All arms will receive an identical capsule dosing for four weeks."
  • "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."
  • "Disease activity and symptoms will be recorded from informed consent through the week 52 trial visit."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether xylitol capsules are safe and can clear C. difficile bacteria from the gut in adults with inflammatory bowel disease (IBD). People will be assigned by chance to take one of two xylitol doses or a placebo (a capsule with no active treatment) for four weeks. Stool testing and checks of gut microbes will continue through week 52.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a form agreeing to join the study.
  • Be age 18 or older.
  • Have IBD: Crohn’s disease, ulcerative colitis, or colitis whose type is unclear.
  • Have IBD that is not active or is mild, based on symptom scores.
  • Be coming for a clinic visit or an outpatient colonoscopy (a test to look inside the colon) for any reason.

Who can't join

  • Cannot give consent to join the study.
  • Have had colon surgery, including colon removal, an ostomy (an opening for waste to leave the body), or a J-pouch (an internal pouch made from intestine). Surgery only to remove the appendix is allowed.
  • Cannot complete the study steps.
  • Use antibiotics long-term.
  • Cannot or do not want to swallow capsules.
  • Are allergic to xylitol.
  • Have a stool test showing Listeria monocytogenes bacteria.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MA