Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Clostridioides Difficile Infection
- Clostridium Difficile Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Patients are randomized to either vancomycin + 2 FMT or 2 placebo. An open-label arm exists for patients with fulminant CDI.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 130 years
- Gender
- Both males and females
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 tre...
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.
Tracking Information
- NCT #
- NCT04885946
- Collaborators
- Innovation Fund Denmark
- Investigators
- Study Chair: Christian L Hvas, PhD Aarhus University Hospital
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