ID

13421

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

  1. 2/4/16 2/4/16 -
  2. 2/11/16 2/11/16 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

SacBo TI Phone Interview Investigational Drug DRKS00000084 NCT01143272

SacBo TI Phone Interview Investigational Drug NCT01143272

Last dose of investigational drug
Description

Last dose of investigational drug

When did the patient receive the last dose of the investigational agent?
Description

Last dose of investigational agent as reported by the patient

Data type

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0013230
When did the patient receive the last dose of the investigational agent?
Description

Last dose of investigational agent as reasoned from the report about the use of antibiotics

Data type

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0013230

Similar models

SacBo TI Phone Interview Investigational Drug NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Last dose of investigational drug
Last dose of investigational agent as reported by the patient
Item
When did the patient receive the last dose of the investigational agent?
date
C1762893 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Last dose of investigational agent as reasoned from the report about the use of antibiotics
Item
When did the patient receive the last dose of the investigational agent?
date
C1762893 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial