Actively Recruiting
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
Led by Benoit Guery · Updated on 2025-09-18
220
Participants Needed
7
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older) at the time of informed consent
- Signed informed consent
- Documented first CDI episode with risk factors for recurrence or first CDI recurrence confirmed by microbiological tests
- No more than 2 CDI episodes within the last 3 months
- Currently taking or starting vancomycin or fidaxomicin treatment for CDI
- Willing and able to take fecal microbiota transplantation capsules
You will not qualify if you...
- Severe or complicated CDI with signs like hypotension, septic shock, or bowel perforation
- Received fecal microbiota transplantation within 6 months before randomization
- History of colectomy, colostomy, ileostomy, or gastrectomy
- Use of metronidazole for current CDI for more than 3 days
- Need for ongoing systemic antibiotics other than prophylactic trimethoprim/sulfamethoxazole
- Expected need for antibiotics for non-CDI reasons in next 8 weeks except prophylactic doses
- Other causes of chronic or acute diarrhea besides CDI
- Inflammatory bowel disease
- Swallowing disorders or prior small bowel obstruction
- Known allergy to vancomycin or fidaxomicin
- Pregnant or breastfeeding women
- Life expectancy less than 10 weeks
- Unable to follow study procedures or give informed consent
- Conditions or medications increasing risk from FMT
- Severely immunocompromised
- No improvement after at least 5 days of anti-CDI antibiotic treatment
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Universitätsspital
Basel, Basel, Switzerland, 4031
Actively Recruiting
2
Inselspital Bern
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
3
HFR Fribourg - Hôpital cantonal
Fribourg, Canton of Fribourg, Switzerland, 1708
Actively Recruiting
4
Kantonsspital St Gallen, HOCH
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
5
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
6
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
7
Institut central des hôpitaux
Sion, Valais, Switzerland, 1950
Actively Recruiting
Research Team
B
Benoit Guery, MD
CONTACT
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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