跳至主要内容
临床试验/NCT06661044
NCT06661044招募中不适用

Exploiting Human Microbiota-associated in Vivo Models for Mechanistic Studies to Understand the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer

University of Aberdeen1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
6
试验地点
1
主要终点
16S rRNA gene sequencing

研究概览

简要总结

The digestive tract (large intestine) contains microorganisms that digest complex carbohydrates in food to produce chemical substances which are beneficial to human health. The population of these microorganisms in faeces (stool samples) could be used to diagnose the health status of a person and this can be changed with the use of antibiotics, diet, radiotherapy or infection.

Dietary fibre supplements can help provide nutrients for the beneficial bacteria from the large intestine to produce useful chemicals that may delay growth or even shrink prostate cancer in patients.

The investigators will feed mice diets containing several dietary fibres (including inulin, pectin and hemp hull) and also faeces from healthy male human volunteers over 60 years old to see what effect this has on the makeup of the bacteria in their gut and the resulting beneficial metabolites (chemicals). For this work, the research team need to obtain four to six fresh faecal samples on the same day, so that these can be mixed fresh and stored for use as faecal microbiota transplant (FMT) in the mice.

The researchers will then test how altering the gut microorganisms with faeces and dietary fibre supplements can influence the growth of prostate cancer cell tumours in mice. The investigators expect to see an effect of the fibres in promoting beneficial bacteria and in shrinking the tumours.

This work will allow the investigators to identify dietary fibres that could be used in nutritional therapies for management of prostate cancer patients in future.

详细描述

Prostate cancer is the commonest cancer in men and the fifth most common cause of cancer-related deaths globally. Increased prostate-specific antigen (PSA) screening and longer life expectancies in men have resulted in a substantial increase in the incidence and prevalence of prostate cancer in older men. Between 2021 and 2022, over 50,000 newly diagnosed cases of prostate cancer were reported in the UK, representing a 27% increase in incidence compared to 2019 and causing over 16,000 deaths.

Prostate cancer in its initial stages maybe asymptomatic and progresses slowly, meaning that some men do not need immediate active treatment but can be monitored on 'active surveillance'. Active surveillance was developed as an approach to addressing overtreatment; by delaying or preventing unnecessary definitive treatment, typically surgical removal of the prostate (radical prostatectomy, RP) or radical radiotherapy to the prostate (RT), and their related complications. It involves routine monitoring of PSA levels, medical imaging, digital rectal exams, and prostate biopsies and is recommended for prostate cancer patients with a low risk of developing aggressive tumours.

The process of active surveillance can be quite stressful for some patients and many of these patients are eager to do everything they can to slow the progression of their disease, including making lifestyle changes such as changing their diet and doing physical exercise.

Diet influences the diversity of the microbiota (archaea, bacteria, fungi and viruses) in the gastrointestinal tract. The gut microbiota play crucial functions in metabolic and regulatory processes that impact the body's immunity and disease development. One can increase the consumption of dietary fibre by providing supplements in powder or capsule form, where the dose administered can be controlled. When these dietary fibres are eaten, commensal colonic bacteria ferment them to produce metabolites, including short-chain fatty acids (SCFAs) which can have anti-tumour effects.

This study team and other researchers have reported the effect of the soluble dietary fibre inulin in delaying tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including bladder and colorectal cancers). Pectin has also been reported to have health benefits such as maintaining the intestinal barrier, improving physical bowel function and reducing glucose and cholesterol absorption. Apple pectin has also been shown to induce apoptosis in colorectal cancer cells.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Men (biologically male) over 60 years old.
  • Regularly pass a bowel motion at least daily.
  • Able to attend the Rowett Institute for consent procedure and able to arrange delivery of fresh faecal sample to the Rowett Institute on the required study day.

排除标准

  • Living with cancer/on active cancer treatment.
  • Active ulcerative colitis or Crohn's disease.
  • Antibiotic therapy within previous 3 months.
  • Diarrhoea from recent foreign travel.
  • Known HIV or Hepatitis B positive.
  • Working directly on specific study for which samples are required.
  • Line managed or supervised by PI of study.

结局指标

主要结局

16S rRNA gene sequencing

时间窗: December 2024 to October 2025

The investigators will extract bacterial DNA for 16S rRNA gene sequencing analysis to compare the baseline microbial community of volunteers to that of the mice microbiota after faecal microbiota transplantation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验