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

ConditionsInflammatory Bowel Disease (IBD)Clostridioides Difficile Infection
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

69 Participants
are divided into 2 treatment groups
Group A: Dose Finding CohortExperimental treatment 1 intervention
Group B: Observational CohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Safety and Efficacy of Xylitol

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

Time frame
8 weeks
2

C. Diff Decolonization

Proportion of patients decolonized of C. difficile at Week 8

Time frame
8 weeks

Secondary outcomes

1

Biomass of C. Difficile

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

Time frame
8 weeks
2

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.

Time frame
26 weeks
3

C. Difficile infection surveillance

Incidence of patients developing C. Difficile Infection through Week 26

Time frame
26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: