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Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (FACIT)

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Fidaxomicin
Vancomycin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

FMT

Fidaxomicin

Vancomycin

Arm Description

Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor

10 days fidaxomicin 200 mg x 2 daily

10 days vancomycin 125 x 4 daily

Outcomes

Primary Outcome Measures

Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
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

Number of patients with clinical resolution 1 week after primary treatment
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
Number of patients with clinical resolution 8 weeks after primary treatment
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
Number of patients with clinical resolution 26 weeks after primary treatment
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
Number of patients with microbiological resolution week 1
Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Number of patients with microbiological resolution week 8
Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Number of patients with microbiological resolution week 26
Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Number of patients with global resolution (Clinical and microbiological resolution) week 1
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
Number of patients with global resolution (Clinical and microbiological resolution) week 26
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
Numerical change in quality of life (EQ5D-3L) week 8 and 26
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
Microbiota pattern changes 1, 8 and 26 weeks
Microbiota profiling, 16S rRNA, absence or presence of specific genera

Full Information

First Posted
April 8, 2016
Last Updated
October 14, 2019
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02743234
Brief Title
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Acronym
FACIT
Official Title
Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT
Arm Type
Experimental
Arm Description
Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor
Arm Title
Fidaxomicin
Arm Type
Active Comparator
Arm Description
10 days fidaxomicin 200 mg x 2 daily
Arm Title
Vancomycin
Arm Type
Active Comparator
Arm Description
10 days vancomycin 125 x 4 daily
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
Intervention Type
Drug
Intervention Name(s)
Fidaxomicin
Intervention Description
Fidaxomicin 200 mg x 2 daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 125 mg x 4 daily for 10 days
Primary Outcome Measure Information:
Title
Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of patients with clinical resolution 1 week after primary treatment
Description
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
Time Frame
1 week
Title
Number of patients with clinical resolution 8 weeks after primary treatment
Description
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
Time Frame
8 weeks
Title
Number of patients with clinical resolution 26 weeks after primary treatment
Description
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
Time Frame
26 weeks
Title
Number of patients with microbiological resolution week 1
Description
Microbiological resolution (negative Clostridium difficile PC test) 1 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Time Frame
1 week
Title
Number of patients with microbiological resolution week 8
Description
Microbiological resolution (negative Clostridium difficile PC test) 8 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Time Frame
8 weeks
Title
Number of patients with microbiological resolution week 26
Description
Microbiological resolution (negative Clostridium difficile PC test) 26 weeks after finishing allocated treatment, without need for rescue FMT or colectomy
Time Frame
26 weeks
Title
Number of patients with global resolution (Clinical and microbiological resolution) week 1
Description
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
Time Frame
1 week
Title
Number of patients with global resolution (Clinical and microbiological resolution) week 26
Description
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
Time Frame
26 weeks
Title
Numerical change in quality of life (EQ5D-3L) week 8 and 26
Description
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
Time Frame
8 and 26 weeks
Title
Microbiota pattern changes 1, 8 and 26 weeks
Description
Microbiota profiling, 16S rRNA, absence or presence of specific genera
Time Frame
1, 8 and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin Exclusion Criteria: Pregnancy or breastfeeding Does not speak or understand the Danish language Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin fulminant colitis which contraindicates medical treatment physician's evaluation that the patient cannot tolerate project inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens F Dahlerup, MD DrMSc
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35463939
Citation
Hammeken LH, Baunwall SMD, Dahlerup JF, Hvas CL, Ehlers LH. Health-related quality of life in patients with recurrent Clostridioides difficile infections. Therap Adv Gastroenterol. 2022 Apr 18;15:17562848221078441. doi: 10.1177/17562848221078441. eCollection 2022.
Results Reference
derived
PubMed Identifier
30610862
Citation
Hvas CL, Dahl Jorgensen SM, Jorgensen SP, Storgaard M, Lemming L, Hansen MM, Erikstrup C, Dahlerup JF. Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection. Gastroenterology. 2019 Apr;156(5):1324-1332.e3. doi: 10.1053/j.gastro.2018.12.019. Epub 2019 Jan 2.
Results Reference
derived

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Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

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