RecruitingNot ApplicableNCT05257538
FMT in Initial CDI
Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
Sponsor
Turku University Hospital
Enrollment
140 participants
Start Date
Aug 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.
Eligibility
Min Age: 18 YearsMax Age: 120 Years
Inclusion Criteria6
- \>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 Criteria6
- 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.
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Interventions
OTHERFMT
Fecal microbiota transfer from a healthy and tested volunteer
OTHERplacebo enema
colored water enema
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05257538
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