Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection

Alexander Khoruts24 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Recurrent C. Difficile Infection

Interventions

Fecal microbiota transplantation ± bezlotoxumabDRUG

Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent. 2. Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation. 3. Failure of standard antibiotic therapies prior to the initial FMT Exclusion Criteria: 1. Pregnancy. 2. Class III or above heart failure.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Clinical failure

Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.

Time frame: 90 days

Data from ClinicalTrials.gov

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