Fecal microbiota transfer for treating initial Clostridioides difficile infections
Official title: Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
Run by Turku University Hospital · NCT05257538 · Data updated 2026-11-12
This study is testing whether a fecal microbiota transfer treatment can help people who are having their first Clostridioides difficile infection by restoring their gut health and preventing the infection from coming back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Turku University Hospital Government |
| Locations | 1 site (Turku) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | April 11, 2025 |
| Trial ID | NCT05257538 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who have a confirmed diagnosis of CDI and have shown clinical symptoms.
✕Probably not a fit
Patients who are pregnant, have ongoing antibacterial treatment, or have had a prior CDI in the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of fecal microbiota transfer (FMT) via retention enema as a treatment for patients experiencing their first episode of Clostridioides difficile infection (CDI). The approach aims to restore the gut microbiota, which is often disrupted by antibiotic treatments, thereby reducing the risk of recurrence. Participants will receive either the FMT or a placebo enema, and the study will assess the effectiveness of this method in preventing CDI recurrence. The study is conducted at multiple hospitals in Finland, focusing on patients who meet specific eligibility criteria.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of CDI in patients after their first episode.
How similar studies have gone: Previous studies have shown promising results for FMT in treating recurrent CDI, indicating that this approach may be effective for initial infections as well.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>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. Exclusion Criteria: * 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.
Where it's running
-
Turku University hospital
Turku, Finland Recruiting
Study contacts
- Study coordinator: Teppo U Stenholm
- Email: teppo.stenholm@tyks.fi
- Phone: 023130000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.
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This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.
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This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.
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This will try a single dose of the antibody AZD5148 versus placebo to see if it prevents repeat C. difficile infections in adults being treated for a current infection.
-
Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics
This trial tests whether taking short-course oral vancomycin while you need systemic antibiotics can prevent a recurrence of C. difficile in adults recently treated for CDI.
-
UDCA added to standard therapy to prevent C. diff recurrence
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.