ID

13440

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. 11-02-16 11-02-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

11 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 AE Occurance? NCT01143272

    Adverse event(s)
    Beschrijving

    Adverse event(s)

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Was there an adverse event?
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542

    Similar models

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

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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