ID

13440

Description

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.

Mots-clés

  1. 11/02/2016 11/02/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

11 février 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272

SacBo PZ: Case Report Form AE Termination Signature AE Occurance? NCT01143272

Adverse event(s)
Description

Adverse event(s)

Alias
UMLS CUI-1
C0877248
Was there an adverse event?
Description

Adverse event(s) If yes, please document adverse event(s)

Type de données

boolean

Alias
UMLS CUI [1]
C0877248

Similar models

SacBo PZ: Case Report Form AE Termination Signature AE Occurance? NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Adverse event(s)
C0877248 (UMLS CUI-1)
Adverse event(s)
Item
Was there an adverse event?
boolean
C0877248 (UMLS CUI [1])

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