An observational study in Recurrent C. Difficile Infection, sponsored by Alexander Khoruts. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Alexander Khoruts · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 24 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with Alexander Khoruts as lead sponsor.
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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.
Exclusion Criteria:
Patients with recurrent C. difficile infections, who failed FMT. This cohort includes patients treated with a combination of bezlotoxumab (Zinplava) and 2nd FMT.
Drug: Fecal microbiota transplantation ± bezlotoxumab
Co-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.
Also known as: FMT; Zinplava
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
Plan to share: Undecided — All relevant data are going to be published.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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