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ID

13420

Descrição

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.

Palavras-chave

  1. 04/02/2016 04/02/2016 -
  2. 11/02/2016 11/02/2016 -
  3. 11/02/2016 11/02/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

11 de fevereiro de 2016

DOI

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Licença

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
    Descrição

    First hospitalization

    Date of first dose of antibiotics
    Descrição

    first dose of antibiotics

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C3173975 (Medication time and date)
    LOINC
    LP116701-6
    UMLS CUI [1,2]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    UMLS CUI [1,3]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    Date of last dose of antibiotics
    Descrição

    last dose of antibiotics

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    UMLS CUI [1,2]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    Duration of antibiotic treatment
    Descrição

    duration of antibiotic treatment

    Tipo de dados

    integer

    Unidades de medida
    • days
    Alias
    UMLS CUI [1,1]
    C0444921 (Duration of treatment)
    SNOMED
    261773006
    UMLS CUI [1,2]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    days
    Last dose of investigational agent
    Descrição

    Last dose of investigational agent

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    UMLS CUI [1,2]
    C1875319 (INVESTIGATIONAL AGENTS)
    Date of end of study
    Descrição

    Date of end of study

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2983670 (Study End Date)
    at discharge/transfer patient is in study phase
    Descrição

    study phase at discharge/transfer

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0030685 (Patient Discharge)
    SNOMED
    58000006
    LOINC
    LP100598-4
    UMLS CUI [2,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,2]
    C0030704 (Patient Transfer)
    SNOMED
    107724000

    Similar models

    SacBo TI Basic Information Basic Information NCT01143272

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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