Saccharomyces boulardii for the PREvention of Antibiotic-associated and Clostridium difficile-associated Diarrhoea in adult hospitalised patients
Completed
- Conditions
- Antibiotic-associated-diarrhoea, Clostridium difficile-associated diarrhoeaInfections and InfestationsDiarrhoea
- Registration Number
- ISRCTN86623192
- Lead Sponsor
- A. Manzoni Hospital, AO Provincia di Lecco (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Eligible patients were those aged over 50 before to be given antibiotics or on antibiotic regimen for less than 48 hours, regardless of the number of antibiotic medications and route of administration, for the treatment of a proven or suspected infection or for prophylaxis.
Exclusion Criteria
1. Diarrhoea accounting for hospital admission or on-going at the time of starting antibiotics
2. Regular intake of probiotics (assumed as specific products, thus excluding those mixed in dairy or other foods) in the period preceding the hospital admission
3. Inability or unwilling to give written informed consent
4. Inability to assume tablets orally or through naso-enteric tubes
5. On-going severe acute pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Antibiotic-associated diarrhoea, defined as the presence of more than three passages of liquid stools per day for at least 2 days or at least five in less than 48 hours<br>2. Clostridium difficile-associated diarrhoea, defined as antibiotic-associated diarrhoea with positive testing for Clostridium difficile toxins A and/or B
- Secondary Outcome Measures
Name Time Method 1. Mortality<br>2. Adverse effects