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ID

13418

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.

Keywords

  1. 2/5/16 2/5/16 -
  2. 2/11/16 2/11/16 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    SacBo TI: Case Report Form End Of Study Code Box DRKS00000084 NCT01143272

    SacBo TI: Case Report Form End Of Study Code Box NCT01143272

    Baseline and follow-up boxes
    Description

    Baseline and follow-up boxes

    What is the code of the box?
    Description

    Code

    Data type

    text

    Alias
    UMLS CUI [1]
    C0805701
    How many capsules are left?
    Description

    number of capsules left

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0006935

    Similar models

    SacBo TI: Case Report Form End Of Study Code Box NCT01143272

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Baseline and follow-up boxes
    Code
    Item
    What is the code of the box?
    text
    C0805701 (UMLS CUI [1])
    number of capsules left
    Item
    How many capsules are left?
    integer
    C0006935 (UMLS CUI [1])

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