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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinplava/FMT | Patients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation ± bezlotoxumab | Drug | Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical failure | Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with history of recurrent C. difficile infection who suffered a relapse without a new antibiotic provocation within 90 days of FMT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
All relevant data are going to be published.
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| C000613978 | bezlotoxumab |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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