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

ConditionsInflammatory Bowel DiseasesClostridioides Difficile Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

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 ≤ 7; 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. 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.

  • Placebo

    Drug

    The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Dose A of XylitolExperimental treatment 1 intervention
Group B: Dose B of XylitolExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

C.difficile decolonization

Absence of C. difficile via PCR in week 8 stool sample

Time frame
8 weeks
2

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)

Time frame
8 weeks

Secondary outcomes

1

biomass of C.difficile

Change in biomass of C. difficile

Time frame
8 weeks
2

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

Time frame
8 weeks
3

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

Time frame
52 weeks
4

C. difficile infection

Incidence of patients developing CDI

Time frame
52 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: