Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea. Randomised, double-blind, placebo-controlled trial
Phase 3
- Conditions
- antibiotic-associated diarrhoeaA04.7Enterocolitis due to Clostridium difficile
- Registration Number
- DRKS00000084
- Lead Sponsor
- Bernhard-Nocht-Institut für Tropenmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 477
Inclusion Criteria
Adult, hospitalized patients receiving systemic antibiotic treatment; patient is competent to contract; patient is physically and psychologically able to follow the trial process; written informed consent.
Exclusion Criteria
Allergy against Saccharomyces boulardii;
Central venous catheter;
Immunosuppression;
Chronic diarrhoea;
Regular intake of Saccharomyces boulardii before beginning of the study;
Systemic antimycotic treatment;
Systemic antibiotic treatment within the last 6 weeks;
Missing contraception (failure rate < 1%/year) for the duration of the study at women in childbearing age, pregnancy or breastfeeding women;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of antibiotic-associated diarrhoea (AAD)
- Secondary Outcome Measures
Name Time Method Cumulative incidence of Clostridium difficile-associated diarrhoea (CDAD) || Cumulative incidence of AAD without evidence of an CDAD || Cumulative incidence of a CDAD within all AAD patients || Occurance of an AAD in dependence from initial number of leucocytes and CRP || Occurance of a CDAD in dependence from initial number of leucocytes and CRP || Incidence density of an AAD or rather CDAD || Average duration of an AAD or rather CDAD || Average stool frequency at an AAD or rather CDAD || Cumulative incidence of stopping or changing the initially applied anibiotic therapy