Status:
UNKNOWN
Fecal Microbiota Transplantation for Early Clostridioides Difficile Infection
Lead Sponsor:
Christian Hvas
Collaborating Sponsors:
Innovation Fund Denmark
Conditions:
Clostridium Difficile Infection
Clostridioides Difficile Infection
Eligibility:
All Genders
18-130 years
Phase:
NA
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 Clostridioi...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04885946
Start Date
June 2 2021
End Date
December 31 2024
Last Update
June 9 2022
Active Locations (1)
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1
Aarhus University Hospital
Aarhus N, Denmark, 8200