Clostridioides Difficile InfectionFinCDINCT05257538
FMT in Initial CDI
A study testing FMT in people with Clostridioides Difficile Infection, run by Turku University Hospital at 1 site in Finland.
Trial summary
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2021to 28 Feb 2028
- Phase
- Interventional
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- C. difficile PCR in feces positive and clinical symptoms of enteritis.
- Full resolution of diarrhea during antibiotic treatment for C. difficile
- No other ongoing antibacterial treatments.
- No ongoing probiotics.
- Signed informed consent.
Who cannot join
- Pregnant
- Ongoing need for antibacterial treatment
- Life expectancy < 1 year
- Prior C. difficile infection in preceding 3 months
- Unable to provide written consent, due to dementia for example.
- Fecal incontinence i.e. inability to retain enema.
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
Turku University hospital
Turku
Teppo Stenholm, 023130000, teppo.stenholm@tyks.fi
About this study
Official title: Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.
Read the detailed description
Clostridioides difficile infections (CDI) remain a significant burden for the patients and the society. According to the National Institute for Health and Welfare (THL), in 2018 there were 4324 CDIs in Finland. C. difficile typically affects patients whose gut microbiota is profoundly damaged by antibiotics. Standard therapy for CDI is antibiotic such as vancomycin. After the standard therapy gut microbiota remains damaged and vulnerable to C difficile reinfection arising from spores that survived the treatment. Early recurrence of CDI is commonly defined as relapse of symptoms and positive testing for fecal C difficile within three months after the previous episode. Recurrent CDI is reported in 10-30% of patients after initial treatment, with recurrence approaching 60% after the third episode.
Fecal microbiota transplantation (FMT) is currently the most effective treatment for recurrent CDI (rCDI), with efficacy of over 90%. Even though FMT is mostly administered endoscopically, it is considered a cost-effective way to treat rCDI patients. FMT is recommended after the second relapse, in other words, after the third antibiotic course for CDI. FMT is most effective in rCDI when administered via colonoscopy. However, colonoscopy is a costly and invasive procedure. The largest study exploring a simple and inexpensive retention enema FMT for rCDI showed a 62% clinical response following a single FMT, and 85% after the second. Baro et al. found that FMT via enema was the most cost-effective initial strategy for the management of second recurrence of community-onset CDI.
In the controlled FMT trials the adverse events have been similar with placebo. Also, the long term safety in up to four years follow up seems to be good. The patients treated with FMT seem to normalize their bowel symptoms faster compared to CDI patients treated with only antibiotics.
FMT reduces antibiotic resistance genes in gut microbiota and therefore has a theoretical potential to reduce infections caused by multi-resistant organisms.
A balanced gut microbiota is important in infection control and essential to normal bowel function. CDI is an indicator of damaged gut microbiota. After a course of antibiotics, the gut microbiota typically becomes less diverse for at least some months. It is not known whether the gut microbiota ever regains its former constitution after such a treatment. We hypothesize that planting a new microbial population soon after antibiotic treatment for CDI reduces the risk of recurrence as well as post-infectious functional bowel disorders.
FMT via colonoscopy is currently recommended after the third CDI (second relapse). Our study explores FMT via inexpensive and minimally invasive retention enema after the first CDI episode.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- FMT, placebo enema
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTOther
Fecal microbiota transfer from a healthy and tested volunteer
placebo enemaOther
colored water enema
| Study group | Role | What they receive |
|---|---|---|
| FMT enema | Active comparator | FMT enema 3-5 days after standard antibiotic treatment Receives: Other: FMT |
| plasebo enema | Placebo comparator | placebo Receives: Other: placebo enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
clostridioides difficile relapse rate
Measured: month 3
Secondary outcomes (9)
Resolution of gastrointestinal symptoms
Primary symptoms of clostridioides difficile infection
Measured: month 3 and 1 year
composition of fecal microbiota
Characterization of fecal microbiome samples down to species level by polymerase chain reaction (PCR)
Measured: month 3 and 1 year
Retention time, i.e. time from FMT to subsequent defecation
Measured: day 1
Fecal microbiota transfer adverse events
possibly transferred infections, complications of administration etc
Measured: within 1 year of administration
Adherence to FMT
Measured: From recruitment until FMT administration. Up to 15 days
Alterations in mood as measured by total score of BDI
0 to >30 points with higher points meaning more severe depression
Measured: month 3 and 1 year
Anxiety as measured by total score of GAD-7
0 to 21 points with higher points meaning more severe anxiety
Measured: month 3 and 1 year
Quality of life as measured by 15D instrument
Measured: month 3 and 1 year
clostridioides difficile relapse rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Aug 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Satakunta Central Hospital, Helsinki University Central Hospital, PaijatHame Central Hospital
- Responsible party
- Principal investigator, Teppo Stenholm, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257538
- Sponsor's protocol ID
- T123/2021
- Acronym
- FinCDI
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05257538
- Acronym / sponsor ID
- FinCDI / T123/2021
- Conditions
- Clostridioides Difficile Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Satakunta Central Hospital, Helsinki University Central Hospital, PaijatHame Central Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 25 Feb 2022 (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.
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.
Detailed description
Clostridioides difficile infections (CDI) remain a significant burden for the patients and the society. According to the National Institute for Health and Welfare (THL), in 2018 there were 4324 CDIs in Finland. C. difficile typically affects patients whose gut microbiota is profoundly damaged by antibiotics. Standard therapy for CDI is antibiotic such as vancomycin. After the standard therapy gut microbiota remains damaged and vulnerable to C difficile reinfection arising from spores that survived the treatment. Early recurrence of CDI is commonly defined as relapse of symptoms and positive testing for fecal C difficile within three months after the previous episode. Recurrent CDI is reported in 10-30% of patients after initial treatment, with recurrence approaching 60% after the third episode.
Fecal microbiota transplantation (FMT) is currently the most effective treatment for recurrent CDI (rCDI), with efficacy of over 90%. Even though FMT is mostly administered endoscopically, it is considered a cost-effective way to treat rCDI patients. FMT is recommended after the second relapse, in other words, after the third antibiotic course for CDI. FMT is most effective in rCDI when administered via colonoscopy. However, colonoscopy is a costly and invasive procedure. The largest study exploring a simple and inexpensive retention enema FMT for rCDI showed a 62% clinical response following a single FMT, and 85% after the second. Baro et al. found that FMT via enema was the most cost-effective initial strategy for the management of second recurrence of community-onset CDI.
In the controlled FMT trials the adverse events have been similar with placebo. Also, the long term safety in up to four years follow up seems to be good. The patients treated with FMT seem to normalize their bowel symptoms faster compared to CDI patients treated with only antibiotics.
FMT reduces antibiotic resistance genes in gut microbiota and therefore has a theoretical potential to reduce infections caused by multi-resistant organisms.
A balanced gut microbiota is important in infection control and essential to normal bowel function. CDI is an indicator of damaged gut microbiota. After a course of antibiotics, the gut microbiota typically becomes less diverse for at least some months. It is not known whether the gut microbiota ever regains its former constitution after such a treatment. We hypothesize that planting a new microbial population soon after antibiotic treatment for CDI reduces the risk of recurrence as well as post-infectious functional bowel disorders.
FMT via colonoscopy is currently recommended after the third CDI (second relapse). Our study explores FMT via inexpensive and minimally invasive retention enema after the first CDI episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT enema | Active comparator | Other: FMTFMT enema 3-5 days after standard antibiotic treatment |
| plasebo enema | Placebo comparator | Other: placebo enemaplacebo |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years
- C. difficile PCR in feces positive and clinical symptoms of enteritis.
- Full resolution of diarrhea during antibiotic treatment for C. difficile
- No other ongoing antibacterial treatments.
- No ongoing probiotics.
Key exclusion criteria (6 listed)
- Pregnant
- Ongoing need for antibacterial treatment
- Life expectancy < 1 year
- Prior C. difficile infection in preceding 3 months
- Unable to provide written consent, due to dementia for example.
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 |
|---|---|---|
| FMTFecal microbiota transfer from a healthy and tested volunteer | Other | FMT enema |
| placebo enemacolored water enema | Other | plasebo enema |
Primary outcome
clostridioides difficile relapse rate
Time frame: month 3
9 secondary outcomes
Resolution of gastrointestinal symptoms
Time frame: month 3 and 1 year
composition of fecal microbiota
Time frame: month 3 and 1 year
Retention time, i.e. time from FMT to subsequent defecation
Time frame: day 1
Fecal microbiota transfer adverse events
Time frame: within 1 year of administration
Adherence to FMT
Time frame: From recruitment until FMT administration. Up to 15 days
Alterations in mood as measured by total score of BDI
Time frame: month 3 and 1 year
Anxiety as measured by total score of GAD-7
Time frame: month 3 and 1 year
Quality of life as measured by 15D instrument
Time frame: month 3 and 1 year
clostridioides difficile relapse rate
Time frame: 1 year
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT in people with Clostridioides Difficile Infection, run by Turku University 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 6 inclusion and 6 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 11 Apr 2025. 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.
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 Teppo U Stenholm (023130000, teppo.stenholm@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clostridioides difficile relapse rate (time frame: month 3). 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 11 Apr 2025.