Clostridioides Difficile Infection RecurrencePhase 3FMT CAP CDINCT07458984
FMT Capsules for rCDI
A Phase 3 study testing Healthy donor stool in people with Clostridioides Difficile Infection Recurrence and FMT, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection Recurrence, FMT
- What is being tested?
- Healthy donor stool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFinland
- Study dates
- 25 Apr 2026to 31 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00290
Perttu Arkkila, Professor, +358504272272 ext. +35894711, perttu.arkkila@hus.fi
About this study
Official title: Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
Read the detailed description
The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.
- Conditions
- Clostridioides Difficile Infection Recurrence, FMT
- Being tested
- Healthy donor stool, placebo capsule
- Keywords
- Clostridioides Difficile infection, FMT, Capsule
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy donor stoolBiological
Also called Fecal microbiota transplantation, FMT
Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
placebo capsuleBiological
Also called Placebo FMT capsules
Copenhagen University Hvidrovre Hospital method for capsule production
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving active treatment | Experimental | CDI patients receiving healthy donor stool by capsules Receives: Biological: Healthy donor stool |
| Placebo arm | Placebo comparator | Placebo FMT capsules Receives: Biological: placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.
Measured: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).
Secondary outcomes (1)
Number of patients with side effects after FMT capsules.
Number of patients with side effects after FMT capsules. Number of Safety of FMT capsules is recorded by contacting the patient by phone call after 1 week and by answering the questionnaire after 1, 4 and 12 weeks after FMT (placebo or active FMT). Questionnaire includes information about any symptoms or signs possible related to recurrecy of CDI, such as fever (defined the temperature over 38 degrees), and diarrhea (defindes as more tahn three loose stool per day). Rate of side effects will be expressed by percentage of the patients.
Measured: One, four and twelve weeks after FMT (placebo or active FMT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start25 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile Infection RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perttu Arkkila, Helsinki University Central Hospital
- Investigators
- Perttu Arkkila, Professor, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458984
- Sponsor's protocol ID
- 00290
- Other IDs
- TYH2025304
- Acronym
- FMT CAP CDI
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT07458984
- Acronym / sponsor ID
- FMT CAP CDI / 00290
- Conditions
- Clostridioides Difficile Infection Recurrence, FMT
- Keywords
- Clostridioides Difficile infection, FMT, Capsule
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.
Detailed description
The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving active treatment | Experimental | Biological: Healthy donor stoolCDI patients receiving healthy donor stool by capsules |
| Placebo arm | Placebo comparator | Biological: placebo capsulePlacebo FMT capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- Pregnancy
- Continuous need for antibiotic treatment
- Previous anaphylactic reactions to any food
- Gastroparesis
- Life-threatening fulminant CDI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy donor stoolAlso: Fecal microbiota transplantation, FMTHealthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital | Biological | Patients receiving active treatment |
| placebo capsuleAlso: Placebo FMT capsulesCopenhagen University Hvidrovre Hospital method for capsule production | Biological | Placebo arm |
Primary outcome
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.
Time frame: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).
The investigators compare the number of patients with rCDI in different groups (placebo vs active FMT group) evaluated by Clostridioides difficile nucleinic acid measurement.
1 secondary outcome
Number of patients with side effects after FMT capsules.
Time frame: One, four and twelve weeks after FMT (placebo or active FMT).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. The investigators have no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Perttu Arkkila, Professor principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Healthy donor stool in people with Clostridioides Difficile Infection Recurrence and FMT, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perttu Arkkila, Professor (+358504272272 ext. +35894711, perttu.arkkila@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: The investigators evaluate the number of patietns who get rCDI within 12 weeks after FMT (Placebo or active FMT).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.