Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (FACIT)

October 14, 2019 updated by: University of Aarhus
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

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 C, Denmark, 8000
        • 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

Description

Inclusion Criteria:

1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin

Exclusion Criteria:

  1. Pregnancy or breastfeeding
  2. Does not speak or understand the Danish language
  3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin
  4. fulminant colitis which contraindicates medical treatment
  5. physician's evaluation that the patient cannot tolerate project inclusion

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FMT
Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor
Other: Fecal microbiota transplantation
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
ACTIVE_COMPARATOR: Fidaxomicin
10 days fidaxomicin 200 mg x 2 daily
Drug: Fidaxomicin
Fidaxomicin 200 mg x 2 daily for 10 days
ACTIVE_COMPARATOR: Vancomycin
10 days vancomycin 125 x 4 daily
Drug: Vancomycin
Vancomycin 125 mg x 4 daily for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
Time Frame: 8 weeks
Global resolution is defined as combined clinical and microbiological resolution, without need for rescue FMT or colectomy. Clinical resolution is absence of abdominal pain (pain score 0 (no pain), 1 (mild pain), 2 (moderate pain), 3 (severe pain)) and less than 3 bowel movements of Bristol 5 or lower, per day. Microbiological resolution is negative Clostridium difficile test 8 weeks after finishing allocated treatment
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with clinical resolution 1 week after primary treatment
Time Frame: 1 week
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 1 week after finishing allocated treatment
1 week
Number of patients with clinical resolution 8 weeks after primary treatment
Time Frame: 8 weeks
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
8 weeks
Number of patients with clinical resolution 26 weeks after primary treatment
Time Frame: 26 weeks
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
26 weeks
Number of patients with microbiological resolution week 1
Time Frame: 1 week
Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
1 week
Number of patients with microbiological resolution week 8
Time Frame: 8 weeks
Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
8 weeks
Number of patients with microbiological resolution week 26
Time Frame: 26 weeks
Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
26 weeks
Number of patients with global resolution (Clinical and microbiological resolution) week 1
Time Frame: 1 week
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 1 week after finishing allocated treatment, without need for rescue FMT or colectomy
1 week
Number of patients with global resolution (Clinical and microbiological resolution) week 26
Time Frame: 26 weeks
Clinical resolution (absence of abdominal pain and less than 3 bowel movements of Bristol 5 or lower, per day) and microbiological resolution(negative Clostridium difficile test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
26 weeks
Numerical change in quality of life (EQ5D-3L) week 8 and 26
Time Frame: 8 and 26 weeks
EQ5D-3L (www.euroqol.com) measures self-reported quality of life in 5 dimensions (each three levels), rendering score from 5 (lowest and best) to 15 (highest and worst) plus an overall reporting of general well being (0, lowest, worst to 100, highest, best). Scoring is obtained week 0,8,26 after randomization. Numerical changes are documented and compared using non-parametric statistics
8 and 26 weeks
Microbiota pattern changes 1, 8 and 26 weeks
Time Frame: 1, 8 and 26 weeks
Microbiota profiling, 16S rRNA, absence or presence of specific genera
1, 8 and 26 weeks

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jens F Dahlerup, MD DrMSc, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2016

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (ESTIMATE)

April 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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