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ID

13420

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. 04-02-16 04-02-16 -
  2. 11-02-16 11-02-16 -
  3. 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 TI Basic Information Basic Information DRKS00000084 NCT01143272

    SacBo TI Basic Information Basic Information NCT01143272

    First hospitalization
    Beschrijving

    First hospitalization

    Date of first dose of antibiotics
    Beschrijving

    first dose of antibiotics

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C3173975
    UMLS CUI [1,2]
    C0205435
    UMLS CUI [1,3]
    C0003232
    Date of last dose of antibiotics
    Beschrijving

    last dose of antibiotics

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1762893
    UMLS CUI [1,2]
    C0003232
    Duration of antibiotic treatment
    Beschrijving

    duration of antibiotic treatment

    Datatype

    integer

    Maateenheden
    • days
    Alias
    UMLS CUI [1,1]
    C0444921
    UMLS CUI [1,2]
    C0003232
    days
    Last dose of investigational agent
    Beschrijving

    Last dose of investigational agent

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1762893
    UMLS CUI [1,2]
    C1875319
    Date of end of study
    Beschrijving

    Date of end of study

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2983670
    at discharge/transfer patient is in study phase
    Beschrijving

    study phase at discharge/transfer

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0030685
    UMLS CUI [2,1]
    C2348568
    UMLS CUI [2,2]
    C0030704

    Similar models

    SacBo TI Basic Information Basic Information NCT01143272

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    First hospitalization
    first dose of antibiotics
    Item
    Date of first dose of antibiotics
    date
    C3173975 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    C0003232 (UMLS CUI [1,3])
    last dose of antibiotics
    Item
    Date of last dose of antibiotics
    date
    C1762893 (UMLS CUI [1,1])
    C0003232 (UMLS CUI [1,2])
    duration of antibiotic treatment
    Item
    Duration of antibiotic treatment
    integer
    C0444921 (UMLS CUI [1,1])
    C0003232 (UMLS CUI [1,2])
    Last dose of investigational agent
    Item
    Last dose of investigational agent
    date
    C1762893 (UMLS CUI [1,1])
    C1875319 (UMLS CUI [1,2])
    Date of end of study
    Item
    Date of end of study
    date
    C2983670 (UMLS CUI [1])
    study phase at discharge/transfer
    Item
    at discharge/transfer patient is in study phase
    text
    C2348568 (UMLS CUI [1,1])
    C0030685 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [2,1])
    C0030704 (UMLS CUI [2,2])

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