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Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03712722
Acronym
CEFTA
Enrollment
100
Registered
2018-10-19
Start date
2018-10-01
Completion date
2024-12-31
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Brief summary

Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Detailed description

Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

Interventions

FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* age 18 or higher * documented recurrence of Clostridium difficile

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Resolution of Clostridium difficile-Associated disease (CDAD)8 weeksNumber of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8

Secondary

MeasureTime frameDescription
Clinical effect week 88 weeksNumber of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower)
Negative CD test week 88 weeksNumber of patients with negative Clostridium difficile toxin test week 8

Countries

Denmark

Contacts

Primary ContactChristian L Hvas, MD PhD
christian.hvas@auh.rm.dk+4528351839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026