Diarrheoa from AAD and CD MedDRA version: 9.1 Level: HLGT Classification code 10004018 Term: Bacterial infectious disorders
Conditions
Interventions
Trade Name: CODEX*5MLD 10CPS 250MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Saccharomyces boulardii
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
AZIENDA OSPEDALIERA PROVINCIALE DI LECCO
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed