| Study name |
Fecal microbiota transplantation for early Clostridioides difficile infection (EarlyFMT) |
| Methods |
Double‐blind, randomized controlled trial |
| Participants |
Inclusion criteria
1 or 2 CDI (within 1 year) defined as: > 3 bowel movements of Bristol 6–7 per day and positive stool CD test Age ≥ 18 years
Exclusion criteria
Pregnancy Does not speak or understand the Danish language Current antibiotic treatment other than vancomycin Current treatment with potential interactions with vancomycin Allergy to vancomycin Previous anaphylactic reactions due to food allergies Continuous need for proton pump inhibitor Documented gastroparesis Fulminant CDI
|
| Interventions |
Intervention
Treatment with vancomycin then single donor FMT from healthy human donors
Comparator
Treatment with vancomycin then placebo consisting of food coloring, water, glycerol
Open‐label for screened, but not randomized participants with fulminant CDI (considered unethical to give placebo) |
| Outcomes |
Primary outcomes
Resolution of CDAD. Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test (time frame: 8 weeks following treatment) Mortality. In the open‐label arm for participants who cannot be randomized due to ethical reasons, the primary outcome is mortality (time frame: 8 weeks following treatment)
Secondary outcomes
Resolution of CDAD. Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test (time frame: 1 week following treatment) Negative CD toxin. Fecal C difficile PCR test (time frame: 1 and 8 weeks following treatment) Mortality (time frame: 8 weeks) Colectomy rate. Date of colectomy (time frame: 8 weeks) Health‐related quality of life measured using EQ‐5D‐5L (time frame: 8 weeks)
|
| Starting date |
May 2021 |
| Contact information |
Christian L Hvas PhD, Consultant, Aarhus University Hospital |
| Notes |
No results posted |
