A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
1 other identifier
observational
12,000
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Typical duration for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 26, 2022
CompletedFirst Posted
Study publicly available on registry
December 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 29, 2024
July 1, 2024
2.8 years
September 26, 2022
July 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
microbiome
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.
baseline
Secondary Outcomes (3)
biochemistry
baseline
metabonomics
baseline
proteomics
baseline
Study Arms (2)
disease group
no intervention
control group
no intervention
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhujiang Hospitallead
- National Natural Science Foundation of Chinacollaborator
Study Sites (50)
Emergency General Hospital
Chaoyang, Beijing Municipality, 100028, China
The People's Hospital Of Nanchuan Chongqing
Nanchuan, Chongqing Municipality, 408400, China
YongChuan hospital of Chongqing Medical Univeristy
Yongchuan, Chongqing Municipality, 402177, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
Foshan, Guangdong, 528200, China
The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
Guangzhou, Guangdong, 510600, China
The seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518107, China
Zhongshan City People's Hospital
Zhongshan, Guangdong, 564000, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
Wuzhou Red Cross Hospital
Tongliao, Guangxi, 543002, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan, 570100, China
Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
Daqing, Heilongjiang, 163316, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150007, China
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150088, China
Jixi Ji Mine Hospital
Jixi, Heilongjiang, China
Qiqihar Hospital of Traditional Chinese Medicine
Qiqihar, Heilongjiang, 161005, China
Luoyang Maternal and Child Health Hospital
Luoyang, Henan, 471000, China
Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Shangqiu First People's Hospital
Shangqiu, Henan, 476100, China
Wuhan Mental Health Center
Wuhan, Hubei, 430012, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Nanzhang People's Hospital
Xianyang, Hubei, 441599, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Affiliated Hospital of Inner Mongolia Minzu University
Wuzhou, Inner Mongolia, 028000, China
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002, China
Affiliated Hospital of Jinggangshan University
Ji’an, Jiangxi, 343000, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangx, 341000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, 330000, China
Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
Changzhi, Shanxi, 046011, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Hospital of Shanxi University of Chinese Medicine
Taiyuan, Shanxi, 030024, China
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi’an, Shanxi, 710004, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077, China
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, 610083, China
Guang'an People's Hospital
Guang’an, Sichuan, 638099, China
The People's Hospital of Leshan
Leshan, Sichuan, 614000, China
Tianjin Binhai New Area Dagang Hospital
Binhai, Tianjin Municipality, 300270, China
Tianjing Medical University Cancer Institute & Hospital
Dayingmen, Tianjin Municipality, 300060, China
Tianjin Beichen Hospital
Guoyuan Xincun, Tianjin Municipality, 300400, China
The First People's Hospital of Kashgar Prefecture
Kashgar, Xinjiang Uygur Autonomous Region, 844000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Qunjing Hospital of Traditional Chinese Medicine
Qujing, Yunnan, 655000, China
Hwa Mei Hospital,University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010, China
Related Publications (1)
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.
PMID: 30150716BACKGROUND
Biospecimen
Feces, saliva, urine, serum, plasma and buffy coat
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yan He
Zhujiang Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 26, 2022
First Posted
December 6, 2022
Study Start
March 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share