Urinary tract infection
Conditions
Interventions
Trade Name: Mutaflor
Product Name: Mutaflor
Product Code: A07FA
Pharmaceutical Form: Oral suspension
Pharmaceutical form of the placebo: Oral suspension
Route of administration of the placebo: Oral us
Sponsors
Oulu University Hopsital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children aged less than two years treated due to urinary tract infection Are the trial subjects under 18? yes Number of subjects for this age range: 530 F.1.2 Adults (18-64 years) no 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: Age more than 2 years Gestational age less than 35 weeks Live threatening infection Congenital intestinal or urinary tract anomaly requiring surgical treatment Ongoing antimicrobial prophylaxis Hospital originated infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze efficacy of probiotic E. coli Nissle in preventing urinary tract infections in children;Secondary Objective: NA;Primary end point(s): Propotion of children with new urinary tract infection during follow up;Timepoint(s) of evaluation of this end point: Follow up of six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of urinary tract infections per person years at risk Hospitalization days Total daily doses on antimicrobials Proportion of children with stomach ache Proportion of children with diarrhea;Timepoint(s) of evaluation of this end point: Follow up of six month, evaluation monthly with questionnaire | — |
Countries
Finland
Contacts
Public ContactDepartment of Pediatrcis
Oulu University Hospital
Outcome results
None listed