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ID

13422

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.

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Versões (3)
  1. 04/02/2016 04/02/2016 -
  2. 11/02/2016 11/02/2016 -
  3. 11/02/2016 11/02/2016 -
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11 de fevereiro de 2016

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Creative Commons BY-NC 3.0
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    SacBo TI: Case Report Form Phone Interview Diary TI DRKS00000084 NCT01143272

    Inglês

    SacBo TI: Case Report Form Phone Interview Diary TI NCT01143272

    1 Formulários  
    Current contact
    Descrição

    Current contact

    Was the current contact a phone call?
    Descrição

    phone call

    Tipo de dados

    boolean

    Was the current contact performed at an alternative date?
    Descrição

    Alternative date (14 days after prior phone call)

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Until what date was the documentation on the current eForm performed?
    Descrição

    documentation on current eform until

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0920316
    UMLS CUI [1,2]
    C0011008
    When is the maximum end of documentation
    Descrição

    maximum end of documentation

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0920316
    UMLS CUI [1,2]
    C0806020
    What date did the current contact take place?
    Descrição

    Date of current contact

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Stool frequency and consistency
    Descrição

    Stool frequency and consistency

    What date do the following items concern?
    Descrição

    Date the next items concern including those items from the following itemgroup

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008
    Was the patient rehospitalized in the study hospital?
    Descrição

    Rehospitalization in study hospital

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    How many hard stools?
    Descrição

    Amount of hard stools

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0278016
    How many soft stools?
    Descrição

    Amount of soft stools

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0577115
    How many mushy or watery stools?
    Descrição

    Amount of mushy or watery stools

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0860527
    UMLS CUI [2]
    C2129214
    Was there no stool on this date or is the amount not known?
    Descrição

    No stool or not known

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0426642
    UMLS CUI [1,2]
    C0011008
    Intake of investigational agent
    Descrição

    Intake of investigational agent

    Did the patient take the investigational agent in the morning?
    Descrição

    Intake of investigational agent in the morning

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0332170
    Did the patient take the investigational agent in the evening?
    Descrição

    Intake of the investigational agent in the evening

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0587117
    Did the patient use any laxatives?
    Descrição

    Use of laxatives

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0282090
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    Similar models

    SacBo TI: Case Report Form Phone Interview Diary TI NCT01143272

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Current contact
    phone call
    Item
    Was the current contact a phone call?
    boolean
    Alternative date
    Item
    Was the current contact performed at an alternative date?
    date
    C0011008 (UMLS CUI [1])
    documentation until
    Item
    Until what date was the documentation on the current eForm performed?
    date
    C0920316 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    end of documentation
    Item
    When is the maximum end of documentation
    date
    C0920316 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Date of current contact
    Item
    What date did the current contact take place?
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Stool frequency and consistency
    Date
    Item
    What date do the following items concern?
    date
    C0011008 (UMLS CUI [1])
    Rehospitalization in study hospital
    Item
    Was the patient rehospitalized in the study hospital?
    boolean
    C0019993 (UMLS CUI [1])
    hard stool
    Item
    How many hard stools?
    integer
    C0278016 (UMLS CUI [1])
    soft stool
    Item
    How many soft stools?
    integer
    C0577115 (UMLS CUI [1])
    mushy or watery stool
    Item
    How many mushy or watery stools?
    integer
    C0860527 (UMLS CUI [1])
    C2129214 (UMLS CUI [2])
    Item
    Was there no stool on this date or is the amount not known?
    integer
    C0426642 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    no stool or not known
    Code List
    Was there no stool on this date or is the amount not known?
    CL Item
    no stool (1)
    CL Item
    not known (2)
    Item Group
    Intake of investigational agent
    Item
    Did the patient take the investigational agent in the morning?
    integer
    C0013230 (UMLS CUI [1,1])
    C0332170 (UMLS CUI [1,2])
    in the morning
    Code List
    Did the patient take the investigational agent in the morning?
    CL Item
    yes (1)
    CL Item
    no (2)
    CL Item
    not known (3)
    Item
    Did the patient take the investigational agent in the evening?
    integer
    C0013230 (UMLS CUI [1,1])
    C0587117 (UMLS CUI [1,2])
    in the evening
    Code List
    Did the patient take the investigational agent in the evening?
    CL Item
    yes (1)
    CL Item
    no (2)
    CL Item
    not known (3)
    Item
    Did the patient use any laxatives?
    integer
    C0282090 (UMLS CUI [1])
    Use of laxatives
    Code List
    Did the patient use any laxatives?
    CL Item
    yes (1)
    CL Item
    no (2)
    CL Item
    not known (3)
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