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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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