Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
- Conditions
- Antibiotic-associated DiarrheaDiarrheaClostridium Difficile
- Interventions
- Drug: Placebo
- Registration Number
- NCT01143272
- Lead Sponsor
- Bernhard Nocht Institute for Tropical Medicine
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 477
- adult patient (≥ 18 years)
- patient hospitalized
- patient receives systemic antibiotic treatment
- patient contractually capable
- patient able to follow study procedures
- informed consent of patient
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Microcristallin cellulose Placebo Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation Saccharomyces boulardii 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
- Primary Outcome Measures
Name Time Method Total Number of Antibiotic-associated Diarrhea Episodes 29 months
- Secondary Outcome Measures
Name Time Method Total Number of Clostridium Difficile-associated Diarrhea Episodes 29 months Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins) 29 months Incidence Density of Antibiotic-associated Diarrhea 29 months Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea 29 months Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea 29 months Total Number of Discontinuation or Change of Initially Prescribed Antibiotic 29 months
Trial Locations
- Locations (14)
Abteilung Akut-Geriatrie, Ev. Krankenhaus Bethanien Iserlohn
🇩🇪Iserlohn, Nordrhein-Westfalen, 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
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
I. Medizinische Klinik und Poliklinik, Johannes-Gutenberg-Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Klinikum Saarbrücken
🇩🇪Saarbrücken, Saarland, Germany
Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Zentrum für Pneumologie
🇩🇪Rotenburg, Niedersachsen, Germany
Klinikum Bremen Ost, Klinik für Innere Medizin
🇩🇪Bremen, Germany
Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm
🇩🇪Ulm, Baden-Würtemberg, Germany
Klinikum St.Georg, Klinik für Infektiologie, Tropenmedizin und Nephrologie
🇩🇪Leipzig, Sachsen, Germany
Knappschaftskrankenhaus Bottrop, Medizinische Klinik
🇩🇪Bottrop, Nordrhein-Westfalen, Germany