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

SOFAR SPA0 个研究点开始时间: 2008年4月10日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-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

•-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

发起方