Treatment of recurrent Clostridium difficile infection with fecal therapy: the FECAL trial (Fecal enema to Eliminate Clostridium difficile Associated Longstanding diarrhea)
Phase 3
- Conditions
- 10017966chronic diarrhea10004018bacterial infections
- Registration Number
- NL-OMON30253
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
Patients who once have been treated with proper antibiotics for positieve C. difficile associated diarrhee and now presenting with recurrence of diarrhee can be included in our study.
Exclusion Criteria
Patients with limited life-expectancy (less than 3 months) are excluded from study participance. Feces donor subjects will be selected form healthy relatives and friends and will be thoroughly screened on contagious diseases in blood and feces.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is response after 3 weeks of initiation of therapy. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are time to cure and time without diarrhea during the<br /><br>observation period of 8 weeks following study inclusion. The study will also<br /><br>include an economic evaluation (based on the secondary outcome measures).</p><br>