Clinical Trial Unit, Swiss Paraplegic Centre, Nottwil, Switzerland.
SCI Population Biobanking & Translational Medicine Group, Swiss Paraplegic Research, Nottwil, Switzerland.
Trials. 2021 Oct 4;22(1):677. doi: 10.1186/s13063-021-05630-w.
Urinary tract infections (UTIs) are common in individuals with neurogenic lower urinary tract dysfunction (NLUTD) following spinal cord injury (SCI). They are not only a great burden for affected individuals, but also cause considerable health costs. Furthermore, recurrent antibiotic treatments of UTIs contribute to the growing problem of bacterial resistance to antimicrobial compounds. Even though there is a multitude of different measures to prevent UTIs in individuals with NLUTD, no clear evidence exists for any of these. Oral immunomodulation with UTI-relevant Escherichia coli lysate may be a promising preventative measure with a good safety profile in individuals with NLUTD. However, currently available data are sparse.
This is a randomized, quasi-blinded, placebo-controlled, mono-centric pilot trial investigating the feasibility of a main trial regarding the effects of a lyophilized lysate of E. coli strains for oral application (Uro-Vaxom®, OM Pharma SA, Meyrin, Switzerland). There will be two parallel groups of 12 participants each. Individuals with acute SCI (duration SCI ≤ 56 days) from 18 to 70 years of age admitted for primary rehabilitation will be eligible. Blood and urine samples will be taken prior to intervention start, at the end of the intervention, and 3 months after intervention termination. The trial intervention will last 90 days. The participants will not be informed regarding the treatment allocation (quasi-blinded). The nursing staff will prepare the daily dose of the allocated treatment from the original packaging. The trial personnel and the biostatistician will be blinded. Feasibility (e.g., recruitment rate, patient attrition), clinical (e.g., number of symptomatic UTIs), and laboratory parameters (e.g., urinary culture, urinary proteo- and microbiome, blood cell counts) as well as adverse events will be collected.
Effective and efficient measures for the prevention of UTIs in individuals with NLUTD are urgently needed. If the conclusion of this pilot is positive regarding feasibility, the effects of oral immunomodulation with a E. coli lysate will be investigated in a larger, sufficiently powered, multi-center trial.
ClinicalTrials.gov NCT04049994 . Registered on 8 August 2019.
脊髓损伤（SCI）后患有神经源性下尿路功能障碍（NLUTD）的个体中，尿路感染（UTI）很常见。它们不仅给患者带来了巨大的负担，还造成了相当大的健康成本。此外，UTI 的反复抗生素治疗导致了细菌对抗微生物化合物耐药性的日益严重的问题。尽管有许多不同的措施可以预防 NLUTD 患者的 UTI，但这些措施都没有明确的证据支持。针对 UTI 的大肠杆菌裂解物的口服免疫调节可能是一种有前途的预防措施，对 NLUTD 患者具有良好的安全性。然而，目前可用的数据很少。
这是一项随机、半盲、安慰剂对照、单中心的试验研究，旨在评估口服应用冻干大肠杆菌裂解物（Uro-Vaxom®，OM Pharma SA，Meyrin，瑞士）对急性 SCI 患者的主要试验的可行性。将有两个平行的 12 名患者的组。年龄在 18 至 70 岁之间，急性 SCI （SCI 持续时间≤56 天），并接受初级康复治疗的患者将有资格参与。在干预开始前、干预结束时和干预结束后 3 个月时采集血液和尿液样本。试验干预将持续 90 天。参与者不会被告知治疗分配情况（半盲）。护理人员将从原始包装中准备每日分配剂量的治疗。试验人员和生物统计学家将被蒙住眼睛。将收集可行性（例如，招募率、患者流失）、临床（例如，有症状 UTI 的数量）和实验室参数（例如，尿培养、尿蛋白和微生物组、血细胞计数）以及不良事件。
迫切需要有效的预防 NLUTD 患者 UTI 的措施。如果这项试验的结果是可行的，那么口服免疫调节大肠杆菌裂解物的效果将在一项更大的、有足够效力的、多中心试验中进行研究。
ClinicalTrials.gov NCT04049994。注册于 2019 年 8 月 8 日。
