ID
13424
Beschrijving
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.
Trefwoorden
Versies (2)
- 05-02-16 05-02-16 -
- 11-02-16 11-02-16 -
Geüploaded op
11 februari 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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SacBo TI: Case Report Form End Of Study Study Discontinuation DRKS00000084 NCT01143272
SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272
Beschrijving
If study discontinuation
Beschrijving
revocation of written consent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0680801
Beschrijving
Lost to follow up
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302313
Beschrijving
retrospectively ineligible
Datatype
integer
Alias
- UMLS CUI [1]
- C1512714
Beschrijving
any other reason
Datatype
boolean
Alias
- UMLS CUI [1]
- C2718058
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SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272
C0680801 (UMLS CUI [1,2])