Evaluation of the ability of the probiotic Lactobacillus casei DG (Enterolactis) to remain into the bladder of patients with spinal cord injury and subject to intermitted catheterization. An open-label pilot study. - ND

• Conditions: patients with spinal cord injury and subject to intermitted vesical catheterization andrecurrence of urinary tract infections; MedDRA version: 9.1Level: LLTClassification code 10054088Term: Urinary tract infection bacterial

• Registration Number: EUCTR2007-007179-18-IT
• Lead Sponsor: SOFAR SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 .