Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

Diarrhea Clinical Trial

— SacBo  

Official title:

Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea - Randomised, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01143272
• Other study ID #: BNI-2009-01
• Secondary ID: 2009-017374-20IS
• Status: Terminated
• Phase: Phase 3
• First received: June 11, 2010
• Last updated: April 15, 2015
• Start date: June 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2015
• Source: Bernhard Nocht Institute for Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available. The investigators hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea. To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult patients in several hospitals.

Description:

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 477
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patient (= 18 years)

• patient hospitalized

• patient receives systemic antibiotic treatment

• patient contractually capable

• patient able to follow study procedures

• informed consent of patient

Exclusion Criteria:

• allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.

• central venous catheter

• immunosuppression

• diarrhoea and/or chronic diarrhoea

• regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study

• systemic antimycotic treatment

• systemic antibiotic treatment within the last 6 weeks

• no protection against conception, pregnancy, or lactation

• simultaneous participation in other clinical trials

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic-associated Diarrhea
• Clostridium Difficile
• Diarrhea

Intervention

Drug:
• Saccharomyces boulardii
Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Knappschaftskrankenhaus Bottrop, Medizinische Klinik	Bottrop	Nordrhein-Westfalen
Germany	Klinikum Bremen Ost, Klinik für Innere Medizin	Bremen
Germany	Agaplesion Diakonieklinikum Hamburg, Klinik für Innere Medizin	Hamburg
Germany	Bethesda Krankenhaus Bergedorf, Klinik für Innere Medizin	Hamburg
Germany	I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Abteilung Akut-Geriatrie, Ev. Krankenhaus Bethanien Iserlohn	Iserlohn	Nordrhein-Westfalen
Germany	Klinikum St.Georg, Klinik für Infektiologie, Tropenmedizin und Nephrologie	Leipzig	Sachsen
Germany	I. Medizinische Klinik und Poliklinik, Johannes-Gutenberg-Universität Mainz	Mainz	Rheinland-Pfalz
Germany	Klinikum Vest GmbH, Behandlungszentrum Paracelsus-Klinik Marl	Marl	Nordrhein-Westfalen
Germany	Abt. Innere Medizin, Krankenhaus Reinbek, St. Adolf -Stift	Reinbek	Schleswig-Holstein
Germany	Klinik und Poliklinik für Innere Medizin, Abteilung für Tropenmedizin und Infektionskrankheiten, Universitätsklinikum Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Zentrum für Pneumologie	Rotenburg	Niedersachsen
Germany	Klinikum Saarbrücken	Saarbrücken	Saarland
Germany	Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm	Ulm	Baden-Würtemberg

Sponsors (2)

Lead Sponsor	Collaborator
Bernhard Nocht Institute for Tropical Medicine	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hazard of any antibiotic-associated diarrhoea	hazard of any antibiotic-associated diarrhoea	29 months	No
Secondary	Hazard of Clostridium difficile-associated diarrhoea		29 months	No
Secondary	Hazard of antibiotic-associated diarrhoea without evidence of Clostridium difficile (toxins)		29 months	No
Secondary	Hazard of Clostridium difficile-associated diarrhoea among all antibiotic-associated diarrhoeas		29 months	No
Secondary	Association of initially increased white blood cell count and c-reactive protein on the incidence of antibiotic-associated diarrhoea		29 months	No
Secondary	Incidence density of AAD or CDAD		29 months	No
Secondary	Average duration of antibiotic-associated diarrhoea and Clostridium difficile-associated diarrhoea		29 months	No
Secondary	Average stool frequency in patients with antibiotic-associated diarrhoea and Clostridium difficile-associated diarrhoea		29 months	No
Secondary	Hazard of discontinuation or change of initially prescribed antibiotic		29 months	No

External Links

•   Clinical trial website
•   Sponsor website