Fecal Microbiota Transplantation (FMT) for Clostridium Difficile (CEFTA)

May 10, 2021 updated by: Christian Hvas, University of Aarhus

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with recurrent Clostridium difficile infection

Description

Inclusion Criteria:

  • age 18 or higher
  • documented recurrence of Clostridium difficile

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rCDI
Adult patients with recurrect Clostridium difficile infection
Other: Faecal microbiota transplantation (FMT)
FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Clostridium difficile-Associated disease (CDAD)
Time Frame: 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effect week 8
Time Frame: 8 weeks
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
Negative CD test week 8
Time Frame: 8 weeks
Number of patients with negative Clostridium difficile toxin test week 8
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (ACTUAL)

October 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-16-02-15-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data access agreement may be made upon request; contact to PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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