Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea (SacBo)

This study has been terminated.
(Masked independent interim analysis: completion of the trial was unlikely.)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Stephan Ehrhardt, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01143272
First received: June 11, 2010
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Antibiotic-associated Diarrhea
Clostridium Difficile
Diarrhea
Drug: Saccharomyces boulardii
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea - Randomised, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Bernhard Nocht Institute for Tropical Medicine:

Primary Outcome Measures:
  • Total Number of Antibiotic-associated Diarrhea Episodes [ Time Frame: 29 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Number of Clostridium Difficile-associated Diarrhea Episodes [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins) [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Incidence Density of Antibiotic-associated Diarrhea [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea [ Time Frame: 29 months ] [ Designated as safety issue: No ]
  • Total Number of Discontinuation or Change of Initially Prescribed Antibiotic [ Time Frame: 29 months ] [ Designated as safety issue: No ]

Enrollment: 477
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saccharomyces boulardii
Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Drug: Saccharomyces boulardii
Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
Other Name: Perenterol® Forte
Placebo Comparator: Microcristallin cellulose
Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Drug: Placebo
Placebo
Other Names:
  • Microcristallin cellulose
  • Matching capsules containing no active ingredients

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143272

Locations
Germany
Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm
Ulm, Baden-Würtemberg, Germany, 89081
Klinik und Poliklinik für Innere Medizin, Abteilung für Tropenmedizin und Infektionskrankheiten, Universitätsklinikum Rostock
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Zentrum für Pneumologie
Rotenburg, Niedersachsen, Germany, 27356
Knappschaftskrankenhaus Bottrop, Medizinische Klinik
Bottrop, Nordrhein-Westfalen, Germany, 46242
Abteilung Akut-Geriatrie, Ev. Krankenhaus Bethanien Iserlohn
Iserlohn, Nordrhein-Westfalen, Germany, 58644
Klinikum Vest GmbH, Behandlungszentrum Paracelsus-Klinik Marl
Marl, Nordrhein-Westfalen, Germany, 45770
I. Medizinische Klinik und Poliklinik, Johannes-Gutenberg-Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Klinikum Saarbrücken
Saarbrücken, Saarland, Germany, 66119
Klinikum St.Georg, Klinik für Infektiologie, Tropenmedizin und Nephrologie
Leipzig, Sachsen, Germany, 04129
Abt. Innere Medizin, Krankenhaus Reinbek, St. Adolf -Stift
Reinbek, Schleswig-Holstein, Germany, 21465
Klinikum Bremen Ost, Klinik für Innere Medizin
Bremen, Germany, 28325
I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Agaplesion Diakonieklinikum Hamburg, Klinik für Innere Medizin
Hamburg, Germany, 20259
Bethesda Krankenhaus Bergedorf, Klinik für Innere Medizin
Hamburg, Germany, 21029
Sponsors and Collaborators
Bernhard Nocht Institute for Tropical Medicine
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Stephan Ehrhardt, MD, MPH Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany
  More Information

Additional Information:
Responsible Party: Stephan Ehrhardt, Lead investigator, Bernhard Nocht Institute for Tropical Medicine
ClinicalTrials.gov Identifier: NCT01143272     History of Changes
Other Study ID Numbers: BNI-2009-01  2009-017374-20  ISRCTN01005546  DRKS00000084 
Study First Received: June 11, 2010
Results First Received: March 17, 2016
Last Updated: June 7, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Bernhard Nocht Institute for Tropical Medicine:
antibiotic
associated
diarrhoea
saccharomyces boulardii
Antibiotic-associated diarrhoea (AAD)
Clostridium difficile-associated-diarrhoea (CDAD)

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on August 29, 2016