Fecal microbiota transfer for treating initial Clostridioides difficile infections
Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
NA · Turku University Hospital · NCT05257538
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Turku University Hospital (other gov) |
| Locations | 1 site (Turku) |
| Trial ID | NCT05257538 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promising results for FMT in treating recurrent CDI, indicating that this approach may be effective for initial infections as well.
Eligibility criteria
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 this trial is running
Turku
- Turku University hospital — Turku, Finland (RECRUITING)
Study contacts
- Study coordinator: Teppo U Stenholm
- Email: teppo.stenholm@tyks.fi
- Phone: 023130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clostridioides Difficile Infection