RecruitingPhase 3

FMT Capsules for rCDI

Finland76 participantsStarted 2026-04-25

Plain-language summary

Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least twice recurrent CDI\* * Patient has had CDI-related diarrhea during infections (3 or more Bristol Stool Form Scale type 6-7 stools) * Other causes of diarrhea have been excluded based on clinical data * Age over 18 years * Remission of symptoms during antibiotic course (metronidazole, vancomycin or fidaxomicin) * No other antibiotic courses * Able to sign the consent form or accept it electronically via Suomi.fi identification * definition of recurrent CDI: CDI-compatible symptoms and a positive stool test Clostridioides difficile nucleic acid test within 12 weeks of the previous infection Exclusion Criteria: * Pregnancy * Continuous need for antibiotic treatment * Previous anaphylactic reactions to any food * Gastroparesis * Life-threatening fulminant CDI * Life expectancy less than 1 year * Inability to sign a consent form for the study

What they're measuring

Number of patients with recurrence of Clostridioides difficile infection (rCDI), defined as positive fecal Clostridioides difficile nucleinic acid measurement and diarrhea after Fecal Microbiota transplantation (FMT) within 12 weeks after FMT.

Timeframe: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).

Trial details

NCT IDNCT07458984

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Perttu Arkkila, Professor

+358504272272 perttu.arkkila@hus.fi

View on ClinicalTrials.gov More Clostridioides Difficile Infection Recurrence trials