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临床试验/NCT05638269
NCT05638269招募中不适用

A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China

Zhujiang Hospital50 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
12,000
试验地点
50
主要终点
microbiome

研究概览

简要总结

The human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.

详细描述

Many studies demonstrate that microbial dysbiosis has been linked to many human pathologies. However, the current understanding of the identification of the disease-associated microbiome signatures remains limited, largely owing to the heterogeneity of microbial community structures which are shaped by the host. Undoubtedly, profiles of microbial biomarkers require validation in large, independent, population-based cohorts from different districts. Based on these, the investigator plan to organize a multicentric cross-sectional cohort, not only to systematically characterize the gut microbiota of various critical chronic diseases, such as liver cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney disease, and subclinical hypothyroidism but also to compare the similarities and differences of the microbiome signatures linked to different regions and different diseases and to further investigate their impacts on microbiota-based diagnostic models. In this study, for each kind of disease, the investigators expect to recruit 500 patients with a confirmed diagnosis and 500 sex- and age-matched controls, to record their information related to demography, body measurement, lifestyle, diet, medication, diseases, and biochemistry, and to collect their feces, saliva, urine and blood samples.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-75 years;
  • living in the province where the hospital is located in the last three years;
  • with a medical diagnosis of one of the target diseases;
  • willing to provide written informed consent.

排除标准

  • female in pregnancy or lactation(unless the subject is pregnant women);
  • with medical diagnoses of other serious illnesses;
  • with a history of bariatric surgery or intestinal resection, except for appendectomy;
  • individual who was treated with drugs in the preceding 1 month, including antibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics; individuals having consumed yogurt more than 3 times in the preceding 1 month; heavy drinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequent alcohol consumers who have drunk per week in the last month.

结局指标

主要结局

microbiome

时间窗: baseline

The microbial composition of the stool and saliva samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. Comparison of microbial abundance and diversity of healthy volunteers and patients with various diseases.

次要结局

  • metabonomics(baseline)
  • proteomics(baseline)
  • biochemistry(baseline)

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan He

Professor

Zhujiang Hospital

研究点 (50)

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