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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03712722
Other study ID # 1-16-02-15-16
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 31, 2024

Study information

Verified date May 2021
Source University of Aarhus
Contact Christian L Hvas, MD PhD
Phone +4528351839
Email christian.hvas@auh.rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).


Description:

Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - age 18 or higher - documented recurrence of Clostridium difficile Exclusion Criteria: - none

Study Design


Intervention

Other:
Faecal microbiota transplantation (FMT)
FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of Clostridium difficile-Associated disease (CDAD) Number of patients with resolution of CDAD, , defined by the absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) or, in the case of abnormal stool frequency or consistency, a negative Clostridium difficile toxin test week 8 8 weeks
Secondary Clinical effect week 8 Number of patients with clinical effect, defined by absense of diarrhea (3 or fewer bowel movements per day) and formed stools (Bristol 5 or lower) 8 weeks
Secondary Negative CD test week 8 Number of patients with negative Clostridium difficile toxin test week 8 8 weeks
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