Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Clostridium Difficile Infection Clinical Trial

— FACIT  

Official title:

Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743234
• Other study ID #: FACIT
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 31, 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infection

Intervention

Other:
• Fecal microbiota transplantation
FMT follows 4-10 days of vancomycin 125 mg x 4 daily

Drug:
• Fidaxomicin
Fidaxomicin 200 mg x 2 daily for 10 days
• Vancomycin
Vancomycin 125 mg x 4 daily for 10 days

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 weeks
Secondary	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	1 week
Secondary	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	8 weeks
Secondary	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	26 weeks
Secondary	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	1 week
Secondary	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	8 weeks
Secondary	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	26 weeks
Secondary	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	1 week
Secondary	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	26 weeks
Secondary	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	8 and 26 weeks
Secondary	Microbiota pattern changes 1, 8 and 26 weeks	Microbiota profiling, 16S rRNA, absence or presence of specific genera	1, 8 and 26 weeks