Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
- Conditions
- Clostridium Difficile Infection
- Interventions
- Registration Number
- NCT02743234
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FMT Fecal microbiota transplantation Fecal microbiota transplantation (FMT) following 4-10 days of vancomycin 125 mg x 4, using cryopreserved feces from a healthy anonymous donor Fidaxomicin Fidaxomicin 10 days fidaxomicin 200 mg x 2 daily Vancomycin Vancomycin 10 days vancomycin 125 x 4 daily
- Primary Outcome Measures
Name Time Method Number of patients with global resolution (clinical resolution AND negative Clostridium difficile PCR test) 8 weeks after primary treatment 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
Name Time Method Number of patients with clinical resolution 1 week after primary treatment 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
Number of patients with clinical resolution 8 weeks after primary treatment 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
Number of patients with clinical resolution 26 weeks after primary treatment 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
Number of patients with microbiological resolution week 1 1 week 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 8 weeks 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 26 weeks 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 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
Number of patients with global resolution (Clinical and microbiological resolution) week 26 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
Numerical change in quality of life (EQ5D-3L) week 8 and 26 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
Microbiota pattern changes 1, 8 and 26 weeks 1, 8 and 26 weeks Microbiota profiling, 16S rRNA, absence or presence of specific genera
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus C, Denmark