patients with spinal cord injury and subject to intermitted vesical catheterization and recurrence of urinary tract infections MedDRA version: 9.1 Level: LLT Classification code 10054088 Term: Urinary tract infection bacterial
Conditions
Interventions
Product Name: Lactobacillus casei DG (Enterolactis)
Pharmaceutical Form: Powder for bladder irrigation
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: CFU/ml colony forming un
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Males aged ≥ 18 and ≤ 60 ; - patients with spinal cord injury and subject to intermitted vesical catheterization - patients with at least one episode of urinary tract infection (supported by positive urine test) no more than 3 months prior to study entry - patients able to understand and accept all the study procedures - patients who have given their free and 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: - Previous genital-urinary surgery - Use of antibiotics within 5 days prior to study entry - patients taking drugs that can modify urine pH - patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable) - patients with history of clinically significant renal, hepatic, cardiac, metabolic or haematological disease - chemotherapy - inability to give a valid informed consent or to properly follow the protocol. - recent history or suspicion of alcohol abuse or drug addiction - any severe pathology that can interfere with the treatment or the clinical or instrumental tests of the trial - previous participation in this study - non compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim is to evaluate if and how long the probiotic Lactobacillus casei DG (Enterolactis) is able to remain into the bladder after instillation through catheter .;Secondary Objective: To evaluate the effectiveness of Lactobacillus casei DG to prevent urinary tract infections in patients subject to intermitted catheterization.;Primary end point(s): how long the probiotic Lactobacillus casei DG (Enterolactis) is able to remain into the bladder after instillation through catheter . | — |
Countries
Italy
Outcome results
None listed