Analysis of Gut Microbiome in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Characterization of gut microbiome
研究概览
简要总结
The research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. In consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. The gut flora will be examined and characterized by a microbiome analysis tool. Negative patients will serve as internal control. The investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.
详细描述
Prostate cancer is the no. 1 cancer among men. Risk factors include Afro-American origin, prostate cancer in a first degree relatives and the presence of BRCA2 genetic mutations. No specific association has been described yet between prostate cancer and specific gut bacteria.
The GI tract is the home of billions of bacteria. The microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. The microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of GI content. All of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs.
The purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male gender
- •age above 45
- •referred for prostate biopsy
排除标准
- •age below 45
- •antimicrobial therapy in the 7 days prior to biopsy
- •previous prostate or pelvic irradiation
- •patients who suffer from inflammatory bowel disease
- •systemic chemotherapy for any reason in the 3 months prior to the biopsy.
研究组 & 干预措施
prostate biopsy patients
a cohort o consecutive patients referred to prostate biopsies. In all patients, a rectal swab will be taken prior to biopsy and antimicrobial treatment. The swab will be cultured and analyzed in the lab for characterization of the microbiome.
干预措施: rectal swab for microbial culture. (Other)
结局指标
主要结局
Characterization of gut microbiome
时间窗: 1 year
Analysis of rectal swab cultures.
Association of prostate cancer patients and specific microbes.
时间窗: 1 year
Relationship between patients with prostate cancer and specific strains of rectal microbes
次要结局
未报告次要终点