FMT in Initial CDI
ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorTurku University Hospital
About this trial
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
Pregnant
Ongoing need for antibacterial treatment
Life expectancy < 1 year
Prior C. difficile infection in preceding 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
FMT
Other interventionFecal microbiota transfer from a healthy and tested volunteer
placebo enema
Other interventioncolored water enema
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: FMT enemaActive comparator 1 intervention
Group B: plasebo enemaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
clostridioides difficile relapse rate
Time frame
month 3Secondary outcomes
1
Resolution of gastrointestinal symptoms
Primary symptoms of clostridioides difficile infection
Time frame
month 3 and 1 year2
composition of fecal microbiota
Characterization of fecal microbiome samples down to species level by polymerase chain reaction (PCR)
Time frame
month 3 and 1 year3
Retention time, i.e. time from FMT to subsequent defecation
Time frame
day 14
Fecal microbiota transfer adverse events
possibly transferred infections, complications of administration etc
Time frame
within 1 year of administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Satakunta Central Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
PaijatHame Central Hospital
Collaborator
Source ClinicalTrials.gov