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Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (FACIT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743234
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Clostridium Difficile Infection Other: Fecal microbiota transplantation Drug: Fidaxomicin Drug: Vancomycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Actual Study Start Date : April 2016
Actual Primary Completion Date : February 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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


Locations
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Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens F Dahlerup, MD DrMSc Associate professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02743234    
Other Study ID Numbers: FACIT
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vancomycin
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents