University of Minnesota
Minneapolis, Minnesota, 55455, United States
Completed
NCT Number: NCT06669936
Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection
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.
Completed
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Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Informed consent.
- Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
- Failure of standard antibiotic therapies prior to the initial FMT
Exclusion criteria
- Pregnancy.
- Class III or above heart failure.
Treatment and study plan
Fecal microbiota transplantation ± bezlotoxumab
DrugCo-administration of bezlotoxumab and FMT in patients with recurrent C. difficile infections who failed FMT alone.
Other names: FMT; Zinplava
Primary outcomes
-
Clinical failure
Time frame: 90 days
Recurrence of C. difficile infection as documented by worsened diarrhea symptoms and laboratory evidence for C. difficile infection in stool.
Sponsors and collaborators
Lead sponsor
Alexander Khoruts
Other
Registry information
Official study title
Efficacy Fo Oral Capsule FMT Combined with Bezlotoxumab Following Initial Failure of FMT Alone
Acronym: ZINFMT
Important dates
- Study start
- 2018
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Nov 1, 2024
- Registry last updated
- Nov 1, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.