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.

Mots-clés

  1. 04/02/2016 04/02/2016 -
  2. 11/02/2016 11/02/2016 -
  3. 11/02/2016 11/02/2016 -
Téléchargé le

11 février 2016

DOI

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Licence

Creative Commons BY-NC 3.0

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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

Type de données

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

Type de données

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)
Type de données
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])

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