Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

Last updated: June 7, 2016
Sponsor: Bernhard Nocht Institute for Tropical Medicine
Overall Status: Terminated

Phase

3

Condition

Hyponatremia

Colic

Clostridium Difficile-associated Diarrhea

Treatment

N/A

Clinical Study ID

NCT01143272
BNI-2009-01
ISRCTN01005546
2009-017374-20
DRKS00000084
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • allergy against yeast and/or Perenterol® forte und/oder placebos containingSaccharomyces 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 daysbefore 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

Total Participants: 477
Study Start date:
June 01, 2010
Estimated Completion Date:
October 31, 2012

Study 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.

Connect with a study center

  • Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm

    Ulm, Baden-Würtemberg 89081
    Germany

    Site Not Available

  • Abt. Pneumologie / Infektiologie u. Gastroenterologie, Klinikum Ernst von Bergmann

    Potsdam, Brandenburg 14467
    Germany

    Site Not Available

  • Klinik und Poliklinik für Innere Medizin, Abteilung für Tropenmedizin und Infektionskrankheiten, Universitätsklinikum Rostock

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Site Not Available

  • Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Zentrum für Pneumologie

    Rotenburg, Niedersachsen 27356
    Germany

    Site Not Available

  • Knappschaftskrankenhaus Bottrop, Medizinische Klinik

    Bottrop, Nordrhein-Westfalen 46242
    Germany

    Site Not Available

  • Abteilung Akut-Geriatrie, Ev. Krankenhaus Bethanien Iserlohn

    Iserlohn, Nordrhein-Westfalen 58644
    Germany

    Site Not Available

  • Klinikum Vest GmbH, Behandlungszentrum Paracelsus-Klinik Marl

    Marl, Nordrhein-Westfalen 45770
    Germany

    Site Not Available

  • I. Medizinische Klinik und Poliklinik, Johannes-Gutenberg-Universität Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Klinikum Saarbrücken

    Saarbrücken, Saarland 66119
    Germany

    Site Not Available

  • Klinikum Saarbrücken

    Saarbrücken, Saarland 66119
    Germany

    Site Not Available

  • Klinikum St.Georg, Klinik für Infektiologie, Tropenmedizin und Nephrologie

    Leipzig, Sachsen 04129
    Germany

    Site Not Available

  • Abt. Innere Medizin, Krankenhaus Reinbek, St. Adolf -Stift

    Reinbek, Schleswig-Holstein 21465
    Germany

    Site Not Available

  • Medizinische Klinik I, Gastroenterologie / Infektiologie / Rheumatologie, Charité-Universitätsmedizin-Berlin, Campus Benjamin Franklin

    Berlin, 12200
    Germany

    Site Not Available

  • Klinikum Bremen Ost, Klinik für Innere Medizin

    Bremen, 28325
    Germany

    Site Not Available

  • Agaplesion Diakonieklinikum Hamburg, Klinik für Innere Medizin

    Hamburg, 20259
    Germany

    Site Not Available

  • Bethesda Krankenhaus Bergedorf, Klinik für Innere Medizin

    Hamburg, 21029
    Germany

    Site Not Available

  • I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

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