ID
13413
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 (3)
- 04.02.16 04.02.16 -
- 11.02.16 11.02.16 -
- 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 TI: Case Report Form Phone Interview Diary TI
SacBo TI: Case Report Form Phone Interview Diary TI
- StudyEvent: ODM
Beschreibung
Stool frequency and consistency
Beschreibung
Date the next items concern including those items from the following itemgroup
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Rehospitalization in study hospital
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019993
Beschreibung
Amount of hard stools
Datentyp
integer
Alias
- UMLS CUI [1]
- C0278016
Beschreibung
Amount of soft stools
Datentyp
integer
Alias
- UMLS CUI [1]
- C0577115
Beschreibung
Amount of mushy or watery stools
Datentyp
integer
Alias
- UMLS CUI [1]
- C0860527
- UMLS CUI [2]
- C2129214
Beschreibung
No stool or not known
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0426642
- UMLS CUI [1,2]
- C0011008
Beschreibung
Intake of investigational agent
Beschreibung
Intake of investigational agent in the morning
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0332170
Beschreibung
Intake of the investigational agent in the evening
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C0587117
Beschreibung
Use of laxatives
Datentyp
integer
Alias
- UMLS CUI [1]
- C0282090
Ähnliche Modelle
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])