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临床试验/NCT01932645
NCT01932645Unknown不适用

Modern Genetic Methods to Test EPS Samples in Prostatitis Patients

University of British Columbia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Expressed Prostatic Secretions (EPS) for bacterial species in prostatitis patients vs controls

研究概览

简要总结

Prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. Although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. Up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. The objective of this study is to look at the etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate.

详细描述

Prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. Although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. Traditional techniques to identify bacteria (e.g. on agar petri plates) are limited in what they can identify. Although HMP (Human Microbiome Project) has turned many mysteries into common sense, little is done on the relationship of bacteria in the prostate for prostatitis. Up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. The objective of this study is to look at the etiology of chronic prostatitis (bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate. Modern sequencing methods, such as 16s rRNA amplification, cloning and sequencing will be used to evaluate the role of bacteria in prostatitis. The basic idea is to survey the microbes present in expressed prostatic fluid using 16s sequencing to compare healthy men and prostatitis patients in a small cohort to see if there are correlations between microbes found and symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • chronic prostatitis (bacteria or non-bacterial prostatitis) with pelvic pain and LUTS (low urinary tract symptom); diagnosed mainly by NIH-CPSI score. We use NIH-CPSI score 15 as a base line for identifying prostatitis patients:those scored more than 15 will be grouped as prostatitis patients.

排除标准

  • Inadequate follow-up data
  • Other types of prostatits patients
  • Patients who in the opinion of the investigators would not be suitable for study
  • UTI patients (within 6 months before enrolment)
  • Antibiotics (within 6 months before enrolment)
  • Urinary tract surgery (within 6 months before enrolment)

结局指标

主要结局

Expressed Prostatic Secretions (EPS) for bacterial species in prostatitis patients vs controls

时间窗: 1 day

Expressed Prostatic Secretions (EPS) will be collected post Digital Rectal Exam (DRE). These biological samples will be tested for bacterial DNA rather than the traditional microbiological culturing techniques. Identification of these bacterial DNA will then be assessed between the groups to determine if prostatitis patients, in fact, do have more bacteria than normal controls.

次要结局

  • VB3 sample or first void after DRE for prostatitis patients vs controls(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben Chew, MD

Associate Professor

University of British Columbia

研究点 (1)

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