a probiotic for the prevention of diarrhoea associated with antibiotics - preda

Conditions: Diarrheoa from AAD and CD
MedDRA version: 9.1Level: HLGTClassification code 10004018Term: Bacterial infectious disorders

Registration Number: EUCTR2008-001426-14-IT

Lead Sponsor: AZIENDA OSPEDALIERA PROVINCIALE DI LECCO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

age > 50 y
need for the administration of single or multiple antibiotics
ability of giving informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

diarrheoa as the responsible for hospital admission or ongoing at the time of deciding wheter starting antibiotic therapy. regular assumption of probiotics the period preceding the hospital admission, impossibility to assuming drugs orally or throughs naso- enteric tubes

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate in pat. taking antibiotics the effect of contemporaney administration of probiotics on AAD and particulary on Cd diarrhoea;Secondary Objective: to evaluate risk factor associated with AAD And CD diarrhoea and to develop a predictive model, to evaluate the severity of the observed cases of ADD and CD diarrheoa by analyzing clinical course, mortality and resource consuption;Primary end point(s): the primary event, diarrhoea (defined according to predeterminated criteria must be rcorded on appropriate forms

Secondary Outcome Measures