ID
13413
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 (3)
- 04-02-16 04-02-16 -
- 11-02-16 11-02-16 -
- 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 Phone Interview Diary TI
SacBo TI: Case Report Form Phone Interview Diary TI
- StudyEvent: ODM
Beschrijving
Stool frequency and consistency
Beschrijving
Date the next items concern including those items from the following itemgroup
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Rehospitalization in study hospital
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschrijving
Amount of hard stools
Datatype
integer
Alias
- UMLS CUI [1]
- C0278016
Beschrijving
Amount of soft stools
Datatype
integer
Alias
- UMLS CUI [1]
- C0577115
Beschrijving
Amount of mushy or watery stools
Datatype
integer
Alias
- UMLS CUI [1]
- C0860527
- UMLS CUI [2]
- C2129214
Beschrijving
No stool or not known
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0426642
- UMLS CUI [1,2]
- C0011008
Beschrijving
Intake of investigational agent
Beschrijving
Intake of investigational agent in the morning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0332170
Beschrijving
Intake of the investigational agent in the evening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0587117
Beschrijving
Use of laxatives
Datatype
integer
Alias
- UMLS CUI [1]
- C0282090
Similar models
SacBo TI: Case Report Form Phone Interview Diary TI
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C2129214 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,2])