ID

13543

Beskrivning

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.

Nyckelord

  1. 2016-02-15 2016-02-15 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

15 februari 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272

SacBo PZ: Case Report Form AE Termination Signature Signature

Investigator's electronic signature
Beskrivning

Investigator's electronic signature

Confirmation of the integrity and accuracy of the data
Beskrivning

Confirmation of the integrity and accuracy of the data

Datatyp

integer

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C1947912
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C0443131

Similar models

SacBo PZ: Case Report Form AE Termination Signature Signature

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Investigator's electronic signature
Item
Confirmation of the integrity and accuracy of the data
integer
C0750484 (UMLS CUI [1,1])
C1947912 (UMLS CUI [1,2])
C0750484 (UMLS CUI [2,1])
C0443131 (UMLS CUI [2,2])
Code List
Confirmation of the integrity and accuracy of the data
CL Item
Accuracy confirmed (1)

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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