Prevention of UTI in persons with spinal cord injury

描述(由申请人提供)：患有脊髓损伤(SCI)的人经历细菌感染的增加。这些感染总是干扰患者的生活质量，经常导致因住院而丧失生产力，从长远来看，还会导致严重的发病率。引起症状性尿路感染(UTI)的细菌通常事先在尿液中发现。然而，并不是所有存在于脊髓损伤患者膀胱中的细菌都会导致尿路感染。细菌通常寄生在大多数依靠留置导尿术的脊髓损伤患者的膀胱中，以及许多其他使用其他方法进行膀胱管理的患者的膀胱中。其中一些细菌会导致尿路感染，而另一些细菌则会在膀胱内定居，而不会引起明显的感染症状。在脊髓损伤患者组中，看似良性的膀胱细菌定植往往没有得到治疗，因为它可能会对更有害的细菌提供一些保护。此前就发现了一种看似无害的细菌，名为E.Coli 83972。几项研究表明，在实验植入后，大肠杆菌83972能够在人的膀胱中持续存在很长一段时间，最长可达四年(平均8至12个月)。只要存在大肠杆菌83972，保持膀胱定植的SCI试验受试者基本上没有膀胱感染的症状。即使尿液中有其他细菌与大肠杆菌83972一起存在，他们基本上也没有症状。尿路感染在脊髓损伤患者中几乎是普遍发生的。它与患者和社会付出的巨大的个人和金钱成本有关。因此，研究E.coil 83972刻意定植膀胱对症状性尿路感染发生的影响有可能改善SCI患者的生活质量，降低医疗费用。这项拟议的研究只有一个目的，就是研究这种方法在脊髓损伤患者中的有效性。PIS提出了一项前瞻性、随机、双盲、安慰剂对照的多中心试验，以评估这一创新治疗方案的临床疗效。

DESCRIPTION (provided by applicant): People who have spinal cord injury (SCI) experience an increase in bacterial infections. These infections always interfere with quality of life of the patient, frequently result in lost productivity due to hospitalization and, in the long term, cause significant morbidity. Bacteria that cause symptomatic urinary tract infections (UTI) can usually be found in the urine beforehand. However, not all bacteria present in the bladder of people with SCI lead to UTI. Bacteria usually colonize the bladder of most SCI patients who rely upon indwelling catheterization, and of many others who use other methods for bladder management. Some of these bacteria result in UTI while other bacteria colonize the bladder without causing overt symptoms of infection. In the SCI patient group, seemingly benign bacterial colonization of the bladder is often left untreated as it may offer some protection against more harmful bacteria. One such seemingly benign bacterium, called E. coli 83972, was identified previously. Several studies revealed that E. coli 83972 was able to persist in the human bladder for extended periods, up to four years (8 to 12 months on average), after it was experimentally implanted. SCI test subjects who maintained bladder colonization with E. coli 83972 remained essentially free from symptoms of bladder infection for as long as E. coli 83972 was present. They remained essentially free of symptoms even when other bacteria were present in the urine together with E. coli 83972. UTI is an almost universal occurrence among persons with SCI. It is associated with large personal and monetary cost to the patient and to society. As a consequence, study of the impact of deliberate bladder colonization with E. coil 83972 on the occurrence of symptomatic UTI has the potential for improving the quality of life of SCI patients and decreasing the cost of health care. The proposed study consists of a single aim that deals with the efficacy of this method in SCI patients. The PIs propose a prospective, randomized, double-blind placebo-controlled multicenter trial to evaluate the clinical efficacy of this innovative therapeutic protocol.