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Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (FACIT)

This study is currently recruiting participants.
Verified April 2016 by University of Aarhus
Sponsor:
ClinicalTrials.gov Identifier:
NCT02743234
First Posted: April 19, 2016
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection

Condition Intervention Phase
Clostridium Difficile Infection Other: Fecal microbiota transplantation Drug: Fidaxomicin Drug: Vancomycin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Microbiological response [ Time Frame: 8 weeks ]
    Negative Clostridium difficile test 8 weeks after finishing allocated treatment


Secondary Outcome Measures:
  • Microbiological response week 1 [ Time Frame: 1 week ]
    Negative Clostridium difficile test one week after finishing treatment

  • Clinical response week 8 [ Time Frame: 8 weeks ]
    Absence of abdominal pain and less than 3 bowel movements per day and a stool consistency of Bristol 5 or lower, corresponding to absence of diarrhea, 8 weeks after finishing allocated treatment

  • Microbiological response week 26 [ Time Frame: 26 weeks ]
    Negative Clostridium difficile test 26 weeks after finishing treatment

  • Clinical response week 26 [ Time Frame: 26 weeks ]
    Absence of abdominal pain and less than 3 bowel movements per day and a stool consistency of Bristol 5 or lower, corresponding to absence of diarrhea, 26 weeks after finishing allocated treatment


Estimated Enrollment: 64
Study Start Date: April 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743234


Contacts
Contact: Christian L Hvas, MD PhD chrishva@rm.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Christian L Hvas, MD PhD       chrishva@rm.dk   
Contact: Jens F Dahlerup, MD DrMSc       jensdahl@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jens F Dahlerup, MD DrMSc Associate professor
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02743234     History of Changes
Other Study ID Numbers: FACIT
First Submitted: April 8, 2016
First Posted: April 19, 2016
Last Update Posted: November 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents