Recurrent C. Difficile Infection
Conditions
Brief 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.
Interventions
DRUGFecal microbiota transplantation ± bezlotoxumab
Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.
Sponsors
Alexander Khoruts
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical failure | 90 days | Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool. |
Countries
United States
Outcome results
None listed