Status:
TERMINATED
Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea
Lead Sponsor:
Bernhard Nocht Institute for Tropical Medicine
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Antibiotic-associated Diarrhea
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT01143272
Start Date
June 1 2010
End Date
October 1 2012
Last Update
July 18 2016
Active Locations (14)
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1
Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm
Ulm, Baden-Würtemberg, Germany, 89081
2
Klinikum Bremen Ost, Klinik für Innere Medizin
Bremen, City state Bremen, Germany, 28325
3
I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20246
4
Agaplesion Diakonieklinikum Hamburg, Klinik für Innere Medizin
Hamburg, Hamburg, Germany, 20259