Rectal enema with a mix of gut bacteria, rectal enema with feacal material from a healthy donor or oral given vancomycin for the treatment of patients with recurrent diarrhea caused by infection with the bacteria Clostridium Difficile.
- Conditions
- Recurrent infection with Clostridium DifficileMedDRA version: 19.0 Level: LLT Classification code 10072994 Term: Clostridium difficile infection recurrence System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-003062-82-DK
- Lead Sponsor
- Department of Medicine, Zealand University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
- Age = 18 years
- Recurrent Clostridium Difficile infection with diarrhea (or toxic megacolon) and verified presence of Clostridium difficile in faeces, and/or pseudomembranoues colitis, diagnosed within 90 days of the last episode of Clostridium difficile infection
- Having received at least one earlier specific treatment for Clostridium difficile infection (at least 10 days of vancomycin with at least 125 mg 4 times daily or at least 10 days of metronidazol with at least 500 mg 3 times a day)
- The patient is allowed to have started treatment with oral vancomycin within 7 days, but does not need to have started treatment with oral vancomycin
- Being able to give informed consent after information in danish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
- Terminal illness with a life expectancy less than 3 months.
- Allergy to vancomycin.
- Other clinically significant gastrointestinal infections.
- Other antibacterial treatment planned for a duration of more than 14 days from time of inclusion (for example for spondylodiscitis, endocarditis or tuberculosis).
- Gastrointestinal disease, which can cause diarrhea or in other way affects symptom reporting, including patients that have undergone colectomy.
- Severely compromised immune system, which makes faecal microbiota transplantation/rectal bacteriotherapy releatively contraindicated by clinical judgement.
- Pregnancy, planned pregnancy or breast feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the treatment effect of rectal bacteriotherapy instillation (RBI) and faecal microbiota transplantation /FMT) against the standard antibotic treatment with vancomycin for patients with recurrent Clostridium Difficile infection in a randomised controlled trial;Secondary Objective: Not applicable;Primary end point(s): Clinical cure, defined as the absence of Clostridium Difficile infection, in 90 days after the end of treatment ;<br> Timepoint(s) of evaluation of this end point: A interim analysis will be done when 30 patients in each treatment group has been followed for 90 days.<br> Final evaluation will be done after 180 days of follow-up after treatment on all patients.<br>
- Secondary Outcome Measures
Name Time Method