Status:
RECRUITING
FMT in Initial CDI
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Satakunta Central Hospital
Helsinki University Central Hospital
Conditions:
Clostridioides Difficile Infection
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- \>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
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05257538
Start Date
August 1 2021
End Date
February 28 2028
Last Update
April 11 2025
Active Locations (1)
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1
Turku University hospital
Turku, Finland