ID

13420

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

Versions (3)
  1. 2/4/16 2/4/16 -
  2. 2/11/16 2/11/16 -
  3. 2/11/16 2/11/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0
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SacBo TI Basic Information Basic Information DRKS00000084 NCT01143272

English

SacBo TI Basic Information Basic Information NCT01143272

1 forms  
First hospitalization
Description

First hospitalization

Date of first dose of antibiotics
Description

first dose of antibiotics

Data type

date

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

last dose of antibiotics

Data type

date

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

duration of antibiotic treatment

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0003232
days
Last dose of investigational agent
Description

Last dose of investigational agent

Data type

date

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

Date of end of study

Data type

date

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

study phase at discharge/transfer

Data type

text

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

SacBo TI Basic Information Basic Information NCT01143272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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