ID
13432
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: Case Report Form Hospitalization Patient Diary DRKS00000084 NCT01143272
SacBo: Case Report Form Hospitalization Patient Diary NCT01143272
Description
Stool frequency and consistency
Description
Day
Data type
text
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Hard Stool
Data type
integer
Alias
- UMLS CUI [1]
- C0278016
Description
Soft Stool
Data type
integer
Alias
- UMLS CUI [1]
- C0577115
Description
Mushy or watery stool
Data type
integer
Alias
- UMLS CUI [1]
- C0860527
- UMLS CUI [2]
- C2129214
Description
No stool or not known
Data type
integer
Alias
- UMLS CUI [1]
- C0015733
- UMLS CUI [2]
- C0439673
Description
Diary duration
Data type
date
Alias
- UMLS CUI [1,1]
- C0920316
- UMLS CUI [1,2]
- C0806020
Description
New page
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SacBo: Case Report Form Hospitalization Patient Diary NCT01143272
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