Prevention of UTI in persons with spinal cord injury

描述（由申请人提供）：脊髓损伤（SCI）患者的细菌感染增加。这些感染总是干扰患者的生活质量，经常由于住院而导致生产力损失，并且从长远来看，导致显著的发病率。引起症状性尿路感染（UTI）的细菌通常可以在尿液中预先发现。然而，并非所有存在于SCI患者膀胱中的细菌都会导致UTI。细菌通常在大多数依靠留置导尿的SCI患者的膀胱中定植，以及许多其他使用其他方法进行膀胱管理的患者。这些细菌中的一些导致UTI，而其他细菌在膀胱中定植而不引起明显的感染症状。在SCI患者组中，膀胱表面上看似良性的细菌定植通常不进行治疗，因为它可能会对更有害的细菌提供一些保护。其中一种看似良性的细菌叫做E. coli83972。一些研究表明，E.大肠杆菌83972在实验性植入人体膀胱后，能够在人体膀胱中持续存在长达4年（平均8至12个月）。维持膀胱定植大肠杆菌的SCI试验受试者。大肠杆菌83972基本上没有膀胱感染的症状，只要大肠杆菌。coli 83972。即使尿液中有其他细菌和大肠杆菌，他们基本上没有症状。coli 83972。UTI在SCI患者中几乎普遍发生。它与患者和社会的巨大个人和金钱成本相关。因此，研究故意膀胱定植与E。coil 83972对症状性UTI发生的影响具有改善SCI患者生活质量和降低医疗费用的潜力。拟议的研究包括一个单一的目标，处理这种方法在SCI患者的疗效。PI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.