ID
13435
Beschreibung
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.
Stichworte
Versionen (2)
- 09.02.16 09.02.16 -
- 11.02.16 11.02.16 -
Hochgeladen am
11. Februar 2016
DOI
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Lizenz
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
Beschreibung
Investigational Drug Starting Box
Alias
- UMLS CUI-1
- C0013230
Beschreibung
Investigational Drug Following Boxes
Beschreibung
Following boxes are necessary if the antibiotic treatment in phase 1 takes longer than 10 days.
Datentyp
integer
Maßeinheiten
- days
Alias
- UMLS CUI [1,1]
- C0444921
- UMLS CUI [1,2]
- C0003232
Beschreibung
Therefore the patient need the following amount of following boxes
Datentyp
integer
Beschreibung
Following boxes that were already given to the patient
Datentyp
text
Beschreibung
Number of the following box
Datentyp
integer
Beschreibung
Following box taken home
Datentyp
boolean
Ähnliche Modelle
SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit NCT01143272
C0029921 (UMLS CUI [2])
C0003232 (UMLS CUI [1,2])