Clostridioides Difficile Infection, Clostridium Difficile Infection
Conditions
Keywords
Fecal microbiota tranplantation, FMT, CDI
Brief summary
Clostridioides difficile (CD) infection (CDI) is a global health threat with an urgent need for new treatment strategies. Faecal microbiota transplantation (FMT) is effective for recurrent Clostridioides difficile infection (CDI), and is currently recommended for multiple (three or more), recurrent CDI infections. The role of FMT earlier in the treatment hierarchy of CDI remains to be determined. In this randomized, double-blinded, placebo-controlled clinical trial, we compare FMT with placebo following standard antibiotic treatment for first or second Clostridioides difficile infection.
Detailed description
This is a parallel arm placebo-controlled clinical trial. We aim to include 84 adult patients with their first or second episode of Clostridioides difficile (formerly Clostridium difficile) infection. All patients receive vancomycin standard therapy. Patients are randomised in a 1:1 ratio to two treatments with capsules that contain either FMT+FMT or placebo+placebo. The primary outcome is absence of C difficile-associated disease 8 weeks after randomisation. Patients who have fulminant disease where it is deemed unethical to give placebo are offered open-label FMT. The primary outcome in patients with fulminant C difficile infection is 8 weeks mortality.
Interventions
OTHERFecal microbiota transplantion (FMT)
Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
OTHERPlacebo
Food coloring, water, glycerol
Sponsors
Innovation Fund Denmark
Christian Hvas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of CD-associated diarrhea (CDAD) week 8 | 8 weeks following treatment | Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test. |
| Mortality week 8 | 8 weeks following treatment | In the open-label arm for patients who cannot be randomized due to ethical reasons, the primary outcome is mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative CD toxin-test week 8 | 8 weeks following treatment | Faecal C difficile PCR test |
| Mortality week 8 | 8 weeks | Date of death |
| Resolution of CD-associated diarrhea (CDAD) week 1 | 1 week following treatment | Measured as a combined clinical resolution or persistent diarrhea, but with negative CD test. |
| Health-related quality of life | 8 weeks | EDQ5D-5L |
| Colectomy rate week 8 | 8 weeks | Date of colectomy |
| Negative CD toxin-test week 1 | 1 week following treatment | Faecal C difficile PCR test |
Countries
Denmark
Outcome results
None listed