FMT in Initial CDI
FinCDI
Fecal Microbiota Transplantation in Initial Clostridioides Difficile Enteritis: a Randomized, Placebo-controlled Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
April 11, 2025
April 1, 2025
5.6 years
January 27, 2022
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
clostridioides difficile relapse rate
month 3
Secondary Outcomes (9)
Resolution of gastrointestinal symptoms
month 3 and 1 year
composition of fecal microbiota
month 3 and 1 year
Retention time, i.e. time from FMT to subsequent defecation
day 1
Fecal microbiota transfer adverse events
within 1 year of administration
Adherence to FMT
From recruitment until FMT administration. Up to 15 days
- +4 more secondary outcomes
Study Arms (2)
FMT enema
ACTIVE COMPARATORFMT enema 3-5 days after standard antibiotic treatment
plasebo enema
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- \>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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Satakunta Central Hospitalcollaborator
- Helsinki University Central Hospitalcollaborator
- PaijatHame Central Hospitalcollaborator
Study Sites (1)
Turku University hospital
Turku, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in gastroenterology and internal medicine
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 25, 2022
Study Start
August 1, 2021
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
April 11, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share