ID

13543

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

  1. 15-02-16 15-02-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

15 februari 2016

DOI

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Licentie

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 Signature

Investigator's electronic signature
Beschrijving

Investigator's electronic signature

Confirmation of the integrity and accuracy of the data
Beschrijving

Confirmation of the integrity and accuracy of the data

Datatype

integer

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C1947912
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C0443131

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SacBo PZ: Case Report Form AE Termination Signature Signature

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Investigator's electronic signature
Item
Confirmation of the integrity and accuracy of the data
integer
C0750484 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C0750484 (UMLS CUI [2,1])
C0443131 (UMLS CUI [2,2])
Code List
Confirmation of the integrity and accuracy of the data
CL Item
Accuracy confirmed (1)

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