Actively Recruiting
Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Episode or First Recurrence A Randomized Controlled, Open-label, Multicenter Phase III Clinical Trial
Led by Benoit Guery · Updated on 2026-06-02
100
Participants Needed
8
Research Sites
43 weeks
Total Duration
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AI-Summary
What this Trial Is About
This trial focuses on adults with Clostridioides difficile infection (CDI), including first episodes with risk factors for recurrence and first recurrences. Researchers aim to compare the effectiveness of adding fecal microbiota transplantation (FMT) to standard antibiotic treatment (vancomycin or fidaxomicin) against standard antibiotic treatment alone. The goal is to see if FMT can prevent further recurrences and improve outcomes in this condition, which is a common cause of healthcare-associated diarrhea and can lead to repeated illness cycles. Participants will be randomly assigned to one of two groups. The experimental group receives 10 days of standard antibiotics followed by FMT capsules administered over two days, with a second FMT given for severe CDI cases. The control group receives only the standard 10-day antibiotic treatment. FMT capsules contain feces from healthy donors and are given orally. This multicenter, open-label phase III trial will observe participants for up to 12 months. During the study, participants will be monitored for clinical cure, recurrence rates, and overall health using questionnaires and medical assessments. The main measure is sustained clinical cure eight weeks after treatment ends. Other outcomes include long-term cure rates, recurrence-free survival, and overall survival over 12 months. Safety and health status will be regularly evaluated to understand the treatment impact and support participant well-being throughout the trial.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 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 antibiotics for CDI within 10 days
- Willing and able to take fecal microbiota transplantation capsules
You will not qualify if you...
- Severe-complicated CDI with signs like hypotension, septic shock, elevated lactate, ileus, toxic megacolon, bowel perforation, or rapid deterioration
- Prior fecal microbiota transplantation within 6 months
- Prior total colectomy, colostomy, ileostomy, or gastrectomy
- Metronidazole treatment alone for current CDI for more than 3 days
- Need for ongoing non-anti-CDI systemic antibiotics except prophylactic trimethoprim/sulfamethoxazole
- Planned antibiotic use for non-CDI reasons in next 8 weeks except prophylactic trimethoprim/sulfamethoxazole
- Other causes of chronic or acute diarrhea beyond CDI
- Inflammatory bowel disease
- Swallowing disorders or prior small bowel obstruction
- Known allergy to vancomycin or fidaxomicin
- Pregnant or breastfeeding
- Life expectancy less than 10 weeks
- Inability to follow study procedures or give informed consent
- Conditions or medications increasing risk from FMT
- Severely immunocompromised
- No response to anti-CDI antibiotics after at least 5 days of treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks including antibiotics and FMT administration
Participants receive antibiotic treatment (vancomycin or fidaxomicin) for 10 days. Those randomized to the FMT arm stop antibiotics for 12 hours to 4 days before receiving oral fecal microbiota transplantation capsules over 2 consecutive days; participants with severe infection receive an additional 2 days of FMT capsules.
Visits for antibiotic treatment and FMT capsule administration as per protocol
Duration - 12 months
Participants are followed for 12 months after treatment completion to monitor clinical cure, recurrence, survival, and health status.
Visits at 8 weeks, 6 months, and 12 months after treatment completion
Trial Site Locations
Total: 8 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
Hirslanden Klinik St Anna
Lucerne, Canton of Lucerne, Switzerland, 6006
Actively Recruiting
5
Kantonsspital St Gallen, HOCH
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
6
CHUV
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
7
Universitätsspital Zürich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
8
Institut central des hôpitaux
Sion, Valais, Switzerland, 1950
Actively Recruiting
Research Team
B
Benoit Guery, MD
P
Project Manager
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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