A Phase 3 interventional study of Fecal microbiota transplantation and Fidaxomicin in Clostridium Difficile Infection, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by University of Aarhus · Phase 3, Interventional, and Treatment
Randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing Clostridium difficile infection
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 64 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
10 days fidaxomicin 200 mg x 2 daily
Drug: Fidaxomicin
10 days vancomycin 125 x 4 daily
Drug: Vancomycin
FMT follows 4-10 days of vancomycin 125 mg x 4 daily
Fidaxomicin 200 mg x 2 daily for 10 days
Vancomycin 125 mg x 4 daily for 10 days
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
Time frame: 8 weeks
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
Time frame: 1 week
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
Time frame: 8 weeks
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
Time frame: 26 weeks
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
Time frame: 1 week
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
Time frame: 8 weeks
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
Time frame: 26 weeks
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
Time frame: 1 week
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
Time frame: 26 weeks
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
Time frame: 8 and 26 weeks
Microbiota pattern changes 1, 8 and 26 weeks
Microbiota profiling, 16S rRNA, absence or presence of specific genera
Time frame: 1, 8 and 26 weeks
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Aarhus