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临床试验/NCT05066048
NCT05066048Unknown不适用

Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Species composition of fecal microbial

研究概览

简要总结

As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing appendectomy due to appendicitis;
  • 6-36 months after appendectomy;
  • Patients with no obvious abnormality observed by colonoscopy;
  • Age between 20 and 85.

排除标准

  • A. Any history of malignancy or disease
  • Any inflammatory bowel disease (IBD) prior to study inclusion;
  • Antibiotics and hormone drugs taken within the last three months;
  • Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
  • Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.

结局指标

主要结局

Species composition of fecal microbial

时间窗: 1 year

The types of microorganisms of fecal microbial

次要结局

  • age in year(baseline, pre-procedure)
  • weight in kilograms(baseline, pre-procedure)
  • height in meters(baseline, pre-procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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