RightFit
Not yet recruitingPhase 4

Use of Fidaxomicin Compared to Vancomycin 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: 26 visits
  • Time periods mentioned: 10 days
  • 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
  • "The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days."
  • "The fidaxomicin arm will receive 200 mg PO BID for 10 days."
  • "In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells."
  • "In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days."
  • "In order to ensure blinding both antibiotics will be concealed in opaque 00 capsule shells."
  • "Disease activity and symptoms will be recorded from time of informed consent through to the week 26 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

This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.

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

Eligibility

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. Presenting for outpatient colonoscopy 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 or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.

Study sites (1)

MA