Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
- Conditions
- Clostridium Difficile Infection
- Interventions
- Other: Faecal microbiota transplantation (FMT)
- Registration Number
- NCT03712722
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- age 18 or higher
- documented recurrence of Clostridium difficile
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description rCDI Faecal microbiota transplantation (FMT) Adult patients with recurrect Clostridium difficile infection
- Primary Outcome Measures
Name Time Method Resolution of Clostridium difficile-Associated disease (CDAD) 8 weeks Number 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 Outcome Measures
Name Time Method Negative CD test week 8 8 weeks Number of patients with negative Clostridium difficile toxin test week 8
Clinical effect week 8 8 weeks Number of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower)
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus N, Denmark