Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and F
The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioid
| Condition(s) | Clostridioides Difficile Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) after standard of care treatment (either vancomycin or fidaxomicin) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first episode and first recurrence of Clostridioides difficile infection (CDI). Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days) followed by FMT by oral capsules (one FMT, i.e. 20 FMT capsules given on 2 consecutive days, and followed by a 2nd FMT in severe CDI). Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days. |
| Who can participate | Inclusion Criteria: 1. Adults (≥18 years old) at the time of informed consent 2. Informed consent signature 3. Medical record documentation of CDI defined as: a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI PCR positive test with Ct \< 25 or a toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea, iii. Presenting at least one of the following risks factors for CDI recurrence: * age \>65 years-old, * hospitalization within the last 3 months, * use of proton pump inhibitors (PPI) within the last 3 mont |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Benoit Guery |
| Locations | Basel, Basel, Switzerland; Bern, Canton of Bern, Switzerland; Fribourg, Canton of Fribourg, Switzerland; Lucerne, Canton of Lucerne, Switzerland; Sankt Gallen, Canton of St. Gallen, Switzerland; Lausanne, Canton of Vaud, Switzerland (+2 more sites) |
| Start date | 2023-03-15 |
| NCT ID | NCT05266807 |
| Official listing | https://clinicaltrials.gov/study/NCT05266807 |