Actively Recruiting
Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection
Led by Helsinki University Central Hospital · Updated on 2026-04-29
76
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of fecal microbiota transplantation (FMT) capsules to treat recurrent Clostridioides difficile infection (rCDI) in a double-blind randomized controlled trial. The study aims to assess the effectiveness and safety of these capsules in patients who have experienced multiple recurrences of CDI. It will also explore whether stool antigen tests or clinical risk factors can help identify which patients are most likely to benefit from this treatment. Participants will be randomly assigned to receive either capsules containing healthy donor stool or placebo capsules produced by a standardized method. The study includes 76 patients who have had recurrent CDI, and the treatments will be given orally in capsule form. The trial is designed to compare outcomes between the active FMT group and the placebo group over a 12-week period following treatment. During the study, participants will be monitored for recurrence of CDI by stool tests and symptoms of diarrhea. Safety will be assessed by tracking any side effects at one, four, and twelve weeks after treatment. The main outcome measured is the number of patients who experience CDI recurrence within 12 weeks after receiving either the FMT capsules or placebo. The study will continue through 2030, with follow-up visits and evaluations to ensure participant safety and treatment adherence.
CONDITIONS
Brief Title
FMT Capsules for rCDI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least two recurrent Clostridioides difficile infections
- Experienced CDI-related diarrhea with 3 or more loose stools during infections
- Other causes of diarrhea have been excluded based on clinical data
- Age over 18 years
- Symptoms improved during antibiotic treatment (metronidazole, vancomycin, or fidaxomicin)
- No other antibiotic courses ongoing
- Able to provide informed consent (including electronic consent)
You will not qualify if you...
- Pregnancy
- Continuous need for antibiotic treatment
- Previous anaphylactic reactions to any food
- Gastroparesis
- Life-threatening severe CDI
- Life expectancy less than 1 year
- Unable to provide informed consent
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 - Up to 12 weeks
Participants receive either healthy donor stool capsules or placebo capsules to treat recurrent Clostridioides difficile infection.
1 baseline visit and 3 follow-up visits at 1, 4, and 12 weeks after treatment
Trial Site Locations
Total: 1 location
1
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00290
Actively Recruiting
Research Team
P
Perttu Arkkila, Professor
S
Suvi Niku, PhD, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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