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

NCT06794944 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025P000187
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection

Keywords

C. difficile; Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• C. difficile decolonization

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

  8 weeks

• 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)

  8 weeks

Secondary Outcomes (3)

• Biomass of C. difficile

  8 weeks

• Long-term effect of C. difficile decolonization on IBD clinical outcomes

  26 weeks

• C. difficile infection surveillance

  26 weeks

Study Arms (2)

Vancomycin

ACTIVE COMPARATOR

Vancomycin is glycopeptide antibiotic that has broad gram-positive coverage. The current approved dose is 125mg PO every 6 hours for 10 days. Appropriate dosing and tolerance of vancomycin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.

Drug: Vancomycin (POC)

Fidaxomicin

ACTIVE COMPARATOR

Fidaxomicin is a macrolide antibiotic. It is narrow spectrum with potent bactericidal activity specifically against C. difficile. The approved dose is 200mg PO twice daily for 10 days. Appropriate dosing and tolerance of fidaxomicin is well defined in both healthy and hospitalized populations, as it is already approved and indicated by the FDA for use in treating C. difficile infection.

Drug: Fidaxomicin

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.

Vancomycin

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.

Fidaxomicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Male or female \> 18 years of age.
• IBD diagnosis (CD, UC or indeterminant Colitis will be permitted.)
• Presenting for outpatient colonoscopy for any indication.

You may not qualify if:

• 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 or sensitivity to vancomycin, fidaxomicin, or microcrystalline cellulose.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections; Colitis, Ulcerative

Interventions

Vancomycin; Fidaxomicin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Jessica Allegretti, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Carlin

CONTACT

6175257322; acarlin@bwh.harvard.edu

Jessica Allegretti, MD, MPH

CONTACT

6177326389; jallegretti@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jessica Ravikoff Allegretti, MD, MPH, FACG, AGAF, Principal Investigator

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)