Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea

Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea – randomised, double-blind, placebo-controlled trial - SacBo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017374-20-DE

Enrollment

1520

Registered

2010-03-11

Start date

2010-04-19

Completion date

Unknown

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic - associated - Diarrhoea (AAD) Clostridium difficile - associated - Diarrhoea (CDAD) MedDRA version: 14.1 Level: LLT Classification code 10012748 Term: Diarrhoea, Clostridium difficile System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10006835 Term: C.difficile diarrhoea System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10055956 Term: Antibiotic-associated diarr

Interventions

Trade Name: Perenterol® forte Product Name: Saccharomyces boulardii Pharmaceutical Form: Capsule INN or Proposed INN: Saccharomyces cerevisiae HANSEN CBS 5926 CAS Number: 8000009178 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactGroup Clinical Studies (SacBo)

Bernhard-Nocht-Institute for Tropical Medicine

sacbo@bni-hamburg.de0049 04042818290

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026