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Search / Trial NCT01143272

Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

Launched by BERNHARD NOCHT INSTITUTE FOR TROPICAL MEDICINE · Jun 11, 2010

Trial Information

Current as of September 21, 2025

Terminated

Keywords

Antibiotic Associated Diarrhoea Saccharomyces Boulardii Antibiotic Associated Diarrhoea (Aad) Clostridium Difficile Associated Diarrhoea (Cdad)

ClinConnect Summary

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 larg...

Gender

ALL

Eligibility 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

About Bernhard Nocht Institute For Tropical Medicine

The Bernhard Nocht Institute for Tropical Medicine (BNITM) is a leading research institution based in Hamburg, Germany, dedicated to advancing the understanding and treatment of tropical diseases. As a prominent sponsor of clinical trials, BNITM focuses on innovative research aimed at improving public health outcomes in resource-limited settings. The institute combines interdisciplinary expertise in tropical medicine, epidemiology, and public health, fostering collaborations with global health organizations and academic partners. With a commitment to translational research, BNITM strives to develop effective interventions and contribute to the global fight against infectious diseases.

Locations

Ulm, Baden Würtemberg, Germany

Rostock, Mecklenburg Vorpommern, Germany

Rotenburg, Niedersachsen, Germany

Bottrop, Nordrhein Westfalen, Germany

Iserlohn, Nordrhein Westfalen, Germany

Marl, Nordrhein Westfalen, Germany

Mainz, Rheinland Pfalz, Germany

Saarbrücken, Saarland, Germany

Leipzig, Sachsen, Germany

Reinbek, Schleswig Holstein, Germany

Bremen, Germany

Hamburg, Germany

Hamburg, Germany

Hamburg, Germany

Ulm, Germany

Patients applied

0 patients applied

Trial Officials

Stephan Ehrhardt, MD, MPH

Principal Investigator

Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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