Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection (EarlyFMT)
Clostridium Difficile Infection, Clostridioides Difficile Infection
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Fecal microbiota tranplantation, FMT, CDI
Eligibility Criteria
Inclusion Criteria:
- 1. or 2. CDI (within a year) defined as: > 3 bowel movements of Bristol 6-7 per day and positive stool CD-test.
- Age 18 years or higher.
Exclusion Criteria:
- Pregnancy
- Does not speak or understand the Danish language
- Current antibiotic treatment other than vancomycin
- Current treatment with potential interations with vancomycin
- Allergy to vancomycin
- Previous anaphylactic reactions due to food allergies
- Continuous need for proton pump inhibitor
- Documented gastroparesis
- Fulminant CDI
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Other
Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation
Vancomycin 125 x 4 for 10 days + 2 Placebo
Open-label for screened, but not randomized patients with fulminant CDI
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.
Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo.
This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical.