Fecal Microbiota Transplantation (FMT) for Clostridium Difficile

Clostridium Difficile Infection Clinical Trial

— CEFTA  

Official title:

Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03712722
• Other study ID #: 1-16-02-15-16
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Enterocolitis, Pseudomembranous
• Infection

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