Prevention of UTI in persons with spinal cord injury

描述（由申请人提供）：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，经常因住院而导致生产力丧失，从长期来看，还会导致严重的发病率。引起症状性尿路感染（UTI）的细菌通常可以事先在尿液中发现。然而，并非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。细菌通常在大多数依赖留置导尿的脊髓损伤患者和许多其他使用其他方法进行膀胱管理的患者的膀胱中定植。其中一些细菌导致尿路感染，而其他细菌则在膀胱中定植，而不会引起明显的感染症状。在脊髓损伤患者组中，膀胱内看似良性的细菌定植往往不加治疗，因为它可能提供一些保护，防止更多的有害细菌。一种看似良性的细菌，被称为大肠杆菌83972，此前已被发现。几项研究表明，大肠杆菌83972在实验植入人体膀胱后，能够在人体膀胱中存活较长时间，最长可达四年（平均8至12个月）。只要大肠杆菌83972存在，维持膀胱定植的SCI受试者基本上没有膀胱感染的症状。即使尿液中含有其他细菌和大肠杆菌83972，他们也基本上没有出现症状。尿路感染在脊髓损伤患者中几乎是普遍存在的。它给患者和社会带来了巨大的个人和金钱成本。因此，研究E. coil 83972在膀胱内定殖对有症状尿路感染发生的影响，有可能改善SCI患者的生活质量，降低医疗成本。拟议的研究只有一个目的，即研究这种方法在脊髓损伤患者中的疗效。PIs提出了一项前瞻性、随机、双盲、安慰剂对照的多中心试验，以评估这种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.