Oral donor fecal capsules for recurrent C. difficile infection
Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection
This study tests whether taking donor fecal (FMT) capsules can prevent further C. difficile recurrences in adults who have already had at least two episodes.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki, Uusimaa) |
| Trial ID | NCT07458984 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized placebo-controlled Phase 3 trial enrolling 76 adults with at least two prior recurrences of Clostridioides difficile infection. Participants who are in remission on antibiotics are randomized to receive either donor stool capsules or placebo capsules and are followed for recurrence and safety outcomes. The trial also examines whether stool antigen tests or clinical risk-factor information can identify which patients benefit most from fecal transplantation. Standard exclusion criteria include pregnancy, ongoing need for antibiotics, gastroparesis, fulminant disease, or limited life expectancy.
Who should consider this trial
Good fit: Adults over 18 who have had at least two episodes of recurrent CDI with prior remission on appropriate antibiotics and who can provide informed consent are the intended participants.
Not a fit: Patients who are pregnant, require continuous antibiotics, have life-threatening fulminant CDI, gastroparesis, prior severe food anaphylaxis, or a life expectancy under one year are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the treatment could offer an easy, non-invasive capsule option to reduce repeat C. difficile infections.
How similar studies have performed: Prior randomized and observational studies have shown fecal transplantation is effective for recurrent CDI, though high-quality phase 3 data specifically on capsule formulations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Helsinki, Uusimaa
- Helsinki University Hospital — Helsinki, Uusimaa, Finland (Recruiting)
Study contacts
- Principal investigator: Perttu Arkkila, Professor — Helsinki University Central Hospital
- Study coordinator: Perttu Arkkila, Professor
- Email: perttu.arkkila@hus.fi
- Phone: +358504272272
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.