NCT06669936

Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection

Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Alexander Khoruts · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.

Detailed description

Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.

Conditions

• Recurrent C. Difficile Infection

Interventions

Type	Name	Description
DRUG	Fecal microbiota transplantation ± bezlotoxumab	Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.

Timeline

• Start date: 2018-05-01
• Primary completion: 2024-10-01
• Completion: 2024-10-28
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: United States