Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea

Conditions: Antibiotic - associated - Diarrhoea (AAD)Clostridium difficile - associated - Diarrhoea (CDAD)
MedDRA version: 14.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10006835Term: C.difficile diarrhoeaSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: LLTClassification code 10055956Term: Antibiotic-associated diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2009-017374-20-DE

Lead Sponsor: Bernhard-Nocht-Institute for Tropical Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1520

Inclusion Criteria

Adult, hospitalized patients receiving systemic antibiotic treatment
Written informed consent
Participant is not participating in any other clinical trial
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 1220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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
Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy of Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea in hospitalized, adult patients.;Secondary Objective: Evaluation of the efficacy of Saccharomyces boulardii for the prevention of Clostridium difficile-associated diarrhoea in hospitalized, adult patients.;Primary end point(s): Cumulative incidence of any antibiotic-associated diarrhoea;Timepoint(s) of evaluation of this end point: End of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cumulative incidence of any Clostridium difficile-associated diarrhoea (CDAD),<br>Cumulative incidence of any AAD without evidence of CDAD,<br>AAD and CDAD,<br>Incidence of any AAD in dependency from initial white blood cell count and CRP,<br>Densitiy of incidence of any AAD and CDAD,<br>Average Duration of any of any AAD and CDAD,<br>Average stool frequency at AAD and CDAD,<br>Cumulative incidence of stopping and changing the initially applied antibiotic treatment<br> ;Timepoint(s) of evaluation of this end point: End of the study