ID
13435
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.
Keywords
Versions (2)
- 2/9/16 2/9/16 -
- 2/11/16 2/11/16 -
Uploaded on
February 11, 2016
DOI
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License
Creative Commons BY-NC 3.0
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SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit DRKS00000084 NCT01143272
SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit NCT01143272
Description
Investigational Drug Starting Box
Alias
- UMLS CUI-1
- C0013230
Description
Investigational Drug Following Boxes
Description
Following boxes are necessary if the antibiotic treatment in phase 1 takes longer than 10 days.
Data type
integer
Measurement units
- days
Alias
- UMLS CUI [1,1]
- C0444921
- UMLS CUI [1,2]
- C0003232
Description
Therefore the patient need the following amount of following boxes
Data type
integer
Description
Following boxes that were already given to the patient
Data type
text
Description
Number of the following box
Data type
integer
Description
Following box taken home
Data type
boolean
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SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit NCT01143272
C0029921 (UMLS CUI [2])
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