Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
- Conditions
- Clostridium Difficile InfectionClostridioides Difficile Infection
- Interventions
- Other: PlaceboOther: Fecal microbiota transplantion (FMT)
- Registration Number
- NCT04885946
- Lead Sponsor
- Christian Hvas
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
-
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vancomycin 125 x 4 for 10 days + 2 Placebo Placebo Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, placebo. Open-label for screened, but not randomized patients with fulminant CDI Fecal microbiota transplantion (FMT) This arm exists for patients with fulminant CDI and for randomization to placebo may be considered unethical. Vancomycin 125 x 4 for 10 days + 2 Fecal Microbota Transplantation Fecal microbiota transplantion (FMT) Patients are required to undergo full treatment with vancomycin and are randomized following completion to, in this arm, FMT.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Negative CD toxin-test week 1 1 week following treatment Faecal C difficile PCR test
Health-related quality of life 8 weeks EDQ5D-5L
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.
Mortality week 8 8 weeks Date of death
Colectomy rate week 8 8 weeks Date of colectomy
Negative CD toxin-test week 8 8 weeks following treatment Faecal C difficile PCR test
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus N, Denmark