The FECAL trial, Fecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea.
Recruiting
- Conditions
- 1. Clostridium difficile<br />2. Recurrent (NLD: recidiverend)<br />3. antibiotic associated diarrhoea<br />4. diarrhoea (NLD: diarree)<br />5. feces (NLD: ontlasting)<br />6. transplantation (NLD: transplantatie).
- Registration Number
- NL-OMON25892
- Lead Sponsor
- Academic Medical Center Amsterdamthe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Patient 18 years or older;
2. proven recurrence of Clostridium difficile associated diarrhoea (positive toxin test and diarrhoea defined as more than 3 loose or watery stools per day or >8 in 48 hours);
Exclusion Criteria
1. Pregnancy;
2. life expectancy of less than three months;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diarrhoea and Clostridium difficile toxin in stool after 10 weeks.
- Secondary Outcome Measures
Name Time Method 1. Diarrhoea and Clostridium difficile toxin in stool after five weeks;<br /><br>2. Costs;<br /><br>3. Quality of life;<br /><br>4. Inflammatory markers.