Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence (FENDER)
Clostridioides Difficile Infection
About this trial
This is an interventional treatment trial for Clostridioides Difficile Infection focused on measuring Clostridioides difficile, Clostridium difficile, Fecal Microbiota Transplantation, Vancomycin, Fidaxomicin
Eligibility Criteria
Inclusion Criteria:
- Adults (≥18 years old) at the time of informed consent
- Informed consent signature
Medical record documentation of first recurrence of CDI defined as:
- Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a clinical picture of CDI combined with a CDI test performed according to CDI diagnosis ESCMID guidelines
- 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 test performed according to CDI diagnosis ESCMID guidelines, with a mandatory toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea.
- No multiple episodes (more than one recurrence) of CDI that occurred within 3 last months.
- Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.
- Willing and able to have FMT by capsule
Exclusion Criteria:
- Complicated CDI (at least one of the following signs or symptoms are present and related to CDI: hypotension requiring vasopressors, intensive care unit admission for a complication of CDI, ileus leading to placement of nasogastric tube, toxic megacolon, colonic perforation, colectomy or colostomy)(2),
- Prior FMT within 6 months of randomization,
- Prior colectomy, colostomy, ileostomy, or gastrectomy.
- Metronidazole already given for the treatment of the first rCDI for more than 3 days,
- Need for continued non-anti-CDI systemic antibiotics,
- Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks,
- Other infectious causes of diarrhea beyond CDI,
- Inflammatory bowel disease,
- Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,
- Known hypersensitivity to vancomycin or fidaxomicin,
- Pregnant/lactating women,
- Estimated patient's life expectancy of less than 10 weeks,
- Inability to follow protocol study procedures,
- Inability to give informed consent,
- Any condition or medications that will put the participant at greater risk from FMT according to the investigator,
- Severely immunocompromised
Sites / Locations
- CHUVRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SoC + oral Fecal Microbiota Transplantation
SoC
Antibiotic (vancomycin 125 mg 4 times daily or fidaxomicin 200 mg 2 times daily, as initially prescribed per SoC) for 10 days, followed 12h to 4 days later by one oral FMT (20 capsules administered at D1 and 20 capsules at D2), and a second oral FMT if CDI is severe.
Antibiotic (vancomycin 125 mg 4 times daily or fidaxomicin 200 mg 2 times daily, as initially prescribed per SoC) for 10 days.