Clinical trial NCT05638269: A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Official title: A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Essential Hypertension
Liver Cancer
Nasopharyngeal Cancer
Pancreatic Cancer
Lung Cancer
Chronic Kidney Diseases
Acute Coronary Syndrome
Epilepsy
Gastric Cancer
Primary Aldosteronism
Subclinical hypothyroïdism
Keywords: cardiovascular disease
exctracoonic cancer
nervous system diseases
endocrine diseases
urological diseases
microbial dysbiosis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2022-12-06
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with essential Hypertension, liver cancer, nasopharyngeal cancer, pancreatic cancer, lung cancer, chronic kidney disease, acute coronary syndrome, epilepsy, gastric cancer, primary aldosteronism or subclinical hypothyroidism hospitalized in our participant hospitals will be eligible to be enrolled. Also, their age- and sex-matched controls making a physical examination in the same hospital will be eligible to be enrolled.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. female in pregnancy or lactation(unless the subject is pregnant women);
2. with medical diagnoses of other serious illnesses;
3. with a history of bariatric surgery or intestinal resection, except for appendectomy；
4. 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.

Primary outcomes:
measure: microbiome
timeFrame: baseline
Secondary outcomes:
measure: biochemistry
timeFrame: baseline
measure: metabonomics
timeFrame: baseline
measure: proteomics
timeFrame: baseline
Other outcomes:
Locations:
city: Chaoyang
country: China
facility: Emergency General Hospital
state: Beijing
city: Nanchuan
country: China
facility: The People's Hospital Of Nanchuan Chongqing
state: Chongqing
city: Yongchuan
country: China
facility: YongChuan hospital of Chongqing Medical Univeristy
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Foshan
country: China
facility: The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
state: Guangdong
city: Shenzhen
country: China
facility: The seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Tongliao
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Cancer Hospital of Guizhou Medical University
state: Guizhou
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Haikou
country: China
facility: Hainan Traditional Chinese Medicine Hospital
state: Hainan
city: Daqing
country: China
facility: Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
state: Heilongjiang
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Sixth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Jixi
country: China
facility: Jixi Ji Mine Hospital
state: Heilongjiang
city: Qiqihar
country: China
facility: Qiqihar Hospital of Traditional Chinese Medicine
state: Heilongjiang
city: Luoyang
country: China
facility: Luoyang Maternal and Child Health Hospital
state: Henan
city: Luoyang
country: China
facility: Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
state: Henan
city: Shangqiu
country: China
facility: Shangqiu First People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Xianyang
country: China
facility: Nanzhang People's Hospital
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Wuzhou
country: China
facility: Affiliated Hospital of Inner Mongolia Minzu University
state: Inner Mongolia Autonomous Region
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
city: Ji'an
country: China
facility: Affiliated Hospital of Jinggangshan University
state: Jiangxi
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangx
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangx
city: Changzhi
country: China
facility: Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Hospital of Shanxi University of Chinese Medicine
state: Shanxi
city: Xi'an
country: China
facility: Xi'an People's Hospital (Xi'an Fourth Hospital)
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: The General Hospital of Western Theater Command PLA
state: Sichuan
city: Guang'an
country: China
facility: Guang'an People's Hospital
state: Sichuan
city: Leshan
country: China
facility: The People's Hospital of Leshan
state: Sichuan
city: Beichen
country: China
facility: Tianjin Beichen Hospital
state: Tianjin
city: Binhai
country: China
facility: Tianjin Binhai New Area Dagang Hospital
state: Tianjin
city: Hexi
country: China
facility: Tianjing Medical University Cancer Institute & Hospital
state: Tianjin
city: Kashgar
country: China
facility: The First People's Hospital of Kashgar Prefecture
state: Xinjiang Uygur Autonomous Region
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Qujing
country: China
facility: Qunjing Hospital of Traditional Chinese Medicine
state: Yunnan
city: Ningbo
country: China
facility: Hwa Mei Hospital,University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Zhujiang Hospital
name: Yan He
role: STUDY_CHAIR
References:
citation: He Y, Wu W, Zheng HM, Li P, McDonald D, Sheng HF, Chen MX, Chen ZH, Ji GY, Zheng ZD, Mujagond P, Chen XJ, Rong ZH, Chen P, Lyu LY, Wang X, Wu CB, Yu N, Xu YJ, Yin J, Raes J, Knight R, Ma WJ, Zhou HW. Regional variation limits applications of healthy gut microbiome reference ranges and disease models. Nat Med. 2018 Oct;24(10):1532-1535. doi: 10.1038/s41591-018-0164-x. Epub 2018 Aug 27.