Diarrhea Clinical Trial
— SacBoOfficial title:
Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea - Randomised, Double-blind, Placebo-controlled Trial
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Bernhard Nocht Institute for Tropical Medicine | German Federal Ministry of Education and Research |
Germany,
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 |
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