ID
13424
Descrizione
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
versioni (2)
- 05/02/16 05/02/16 -
- 11/02/16 11/02/16 -
Caricato su
11 febbraio 2016
DOI
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Licenza
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
Descrizione
If study discontinuation
Descrizione
revocation of written consent
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0680801
Descrizione
Lost to follow up
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C1302313
Descrizione
retrospectively ineligible
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C1512714
Descrizione
any other reason
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C2718058
Similar models
SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272
C0680801 (UMLS CUI [1,2])