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NCT Number: NCT06799039

Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Disease (IBD) Bacterial Infections Bacterial Infections and Mycoses Clostridioides Difficile Infection Clostridium Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.
  • Currently pregnant or breastfeeding

Treatment and study plan

Xylitol

Drug

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.

Primary outcomes

  1. Safety and Efficacy of Xylitol

    Time frame: 8 weeks

    Incidence of Treatment Emergent Adverse Events (TEAEs) through Week 8

  2. C. Diff Decolonization

    Time frame: 8 weeks

    Proportion of patients decolonized of C. difficile at Week 8

Secondary outcomes

  1. Biomass of C. Difficile

    Time frame: 8 weeks

    Change in biomass of C. difficile in patients at Week 8

  2. Effect of C. difficile decolonization on Inflammatory Bowel Disease (IBD) clinical outcomes

    Time frame: 26 weeks

    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.

  3. C. Difficile infection surveillance

    Time frame: 26 weeks

    Incidence of patients developing C. Difficile Infection through Week 26

Study contacts

Contact information is provided by the study sponsor or research team.

Heidy Cabral

CONTACT

[email protected]

617-525-7322

Jessica Allegretti, MD MPH

CONTACT

617-732-6389

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 29, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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