Crohn'sUCNot yet recruiting

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Phase 4 · Testing Vancomycin (POC) and Fidaxomicin · 1 site · Brigham and Women's Hospital

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Vancomycin (POC) (a drug) and Fidaxomicin (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD) and Clostridioides Difficile Infection.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

Signed informed consent.
Male or female > 18 years of age.
IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.)

Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 60 participants are expected to take part.
Start date: 2026-09 (planned).
Main results expected around 2030-09-01 (estimate from the record).
1 study site listed in United States.

Main thing being measured

C. difficile decolonization (8 weeks)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional
Conditions	Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection
Lead sponsor	Brigham and Women's Hospital
Enrollment	60 (estimated)
Start date	2026-09
Primary completion (est.)	2030-09-01
First posted	2025-01-27
Last updated	2025-11-03
Official title	Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
ClinicalTrials.gov ID	NCT06794944

Interventions

Vancomycin (POC) (Drug)
Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. Patients will receive 125mg PO every 6 hours for 10 days.
Fidaxomicin (Drug)
Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. Patients will receive 200mg PO twice daily for 10 days.

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
Brigham and Women's Hospital	Boston, Massachusetts	United States

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.