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
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0003232
Date of last dose of antibiotics
Descrição

last dose of antibiotics

Tipo de dados

date

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

duration of antibiotic treatment

Tipo de dados

integer

Unidades de medida
  • days
Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0003232
days
Last dose of investigational agent
Descrição

Last dose of investigational agent

Tipo de dados

date

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

Date of end of study

Tipo de dados

date

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

study phase at discharge/transfer

Tipo de dados

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
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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