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ID

13429

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. 2/8/16 2/8/16 -
  2. 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 PZ: Case Report Form First Visit CRP, Leukocytes DRKS00000084 NCT01143272

    SacBo PZ: Case Report Form First Visit CRP, Leukocytes NCT01143272

    Examination date
    Description

    Examination date

    What date did the examination take place?
    Description

    Examination date. In the time intervall: a) 4 days before the first dose of the antibiotic initially used until b) the day of the first dose of the antibiotic initially used

    Data type

    date

    Alias
    UMLS CUI [1]
    C0260877
    CRP
    Description

    CRP

    Alias
    UMLS CUI-1
    C0201657
    What was the CRP value?
    Description

    CRP value

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0201657
    Was the CRP measurement not performed?
    Description

    CRP measurement not done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0201657
    UMLS CUI [1,2]
    C1272696
    Is the unit mg/L?
    Description

    Unit mg/L

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0439268
    Is the unit mg/dl?
    Description

    Unit mg/dL

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0439269
    Was a different unit used?
    Description

    Different unit

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519795
    What was the unit that was used?
    Description

    Different unit specification

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Leukocytes
    Description

    Leukocytes

    Alias
    UMLS CUI-1
    C0023516
    What was the measured leukocyte value?
    Description

    Leukocytes value

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023508
    Was the leukocyte measurement not performed?
    Description

    Leukocyte measurement not performed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C1272696
    Is the unit 10**9/L? 10**9/L equals: 1000/mcL, 10*3/mcL, /nL, G/L, Gpt/L, Giga/L
    Description

    Unit 10**9/L

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0456615
    Is the unit /mcL = /mm3?
    Description

    Unit /mcL = /mm3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1300557
    Was a different unit used?
    Description

    Different unit

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519795
    What was the unit that was used?
    Description

    Different unit specification

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795

    Similar models

    SacBo PZ: Case Report Form First Visit CRP, Leukocytes NCT01143272

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Examination date
    Examination date
    Item
    What date did the examination take place?
    date
    C0260877 (UMLS CUI [1])
    Item Group
    CRP
    C0201657 (UMLS CUI-1)
    CRP
    Item
    What was the CRP value?
    integer
    C0201657 (UMLS CUI [1])
    CRP measurement not done
    Item
    Was the CRP measurement not performed?
    boolean
    C0201657 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Unit mg/L
    Item
    Is the unit mg/L?
    boolean
    C0439268 (UMLS CUI [1])
    Unit mg/dL
    Item
    Is the unit mg/dl?
    boolean
    C0439269 (UMLS CUI [1])
    Different unit
    Item
    Was a different unit used?
    boolean
    C1519795 (UMLS CUI [1])
    Different unit specification
    Item
    What was the unit that was used?
    text
    C1519795 (UMLS CUI [1])
    Item Group
    Leukocytes
    C0023516 (UMLS CUI-1)
    Leukocytes value
    Item
    What was the measured leukocyte value?
    text
    C0023508 (UMLS CUI [1])
    Leukocyte measurement not performed
    Item
    Was the leukocyte measurement not performed?
    boolean
    C0023508 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Unit 10**9/L
    Item
    Is the unit 10**9/L? 10**9/L equals: 1000/mcL, 10*3/mcL, /nL, G/L, Gpt/L, Giga/L
    boolean
    C0456615 (UMLS CUI [1])
    Unit /mcL = /mm3
    Item
    Is the unit /mcL = /mm3?
    boolean
    C1300557 (UMLS CUI [1])
    Different unit
    Item
    Was a different unit used?
    boolean
    C1519795 (UMLS CUI [1])
    Different unit specification
    Item
    What was the unit that was used?
    text
    C1519795 (UMLS CUI [1])

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