Clinical trial Recruiting at 1 site Interventional Ages 18 to 120

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 typeInterventional
Ages18 Years to 120 Years
SexAll
Enrollment140 (estimated)
SponsorTurku University Hospital
Government
Locations1 site (Turku)
StatusRecruiting
StartedAugust 1, 2021
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2028
Registry record updatedApril 11, 2025
Trial IDNCT05257538 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.