NCT04626947

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: David Binion, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.

Detailed description

Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn Disease
• C. Diff. Infections

Interventions

Type	Name	Description
BIOLOGICAL	Bezlotoxumab	Bezlotoxumab infusion

Timeline

• Start date: 2021-10-14
• Primary completion: 2024-04-24
• Completion: 2024-05-31
• First posted: 2020-11-13
• Last updated: 2025-06-05
• Results posted: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study