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

NCT ID: NCT05638269

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Essential Hypertension Liver Cancer Nasopharyngeal Cancer Pancreatic Cancer Lung Cancer Chronic Kidney Diseases Acute Coronary Syndrome Epilepsy Gastric Cancer Primary Aldosteronism Subclinical hypothyroïdism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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disease group

no intervention

no intervention

Intervention Type OTHER

Observational studies, no intervention

control group

no intervention

no intervention

Intervention Type OTHER

Observational studies, no intervention

Interventions

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no intervention

Observational studies, no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yan He

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan He

Role: STUDY_CHAIR

Zhujiang Hospital

Locations

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Emergency General Hospital

Chaoyang, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The People's Hospital Of Nanchuan Chongqing

Nanchuan, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

YongChuan hospital of Chongqing Medical Univeristy

Yongchuan, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status NOT_YET_RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status NOT_YET_RECRUITING

The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )

Foshan, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital )

Guangzhou, Guangdong, China

Site Status RECRUITING

The seventh Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status NOT_YET_RECRUITING

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status RECRUITING

Wuzhou Red Cross Hospital

Tongliao, Guangxi, China

Site Status RECRUITING

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status NOT_YET_RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Site Status RECRUITING

Hainan Traditional Chinese Medicine Hospital

Haikou, Hainan, China

Site Status NOT_YET_RECRUITING

Daqing People's Hospital(The Fifth Affiliated Hospital of Harbin Medical University)

Daqing, Heilongjiang, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The Sixth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Jixi Ji Mine Hospital

Jixi, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Qiqihar Hospital of Traditional Chinese Medicine

Qiqihar, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Luoyang Maternal and Child Health Hospital

Luoyang, Henan, China

Site Status NOT_YET_RECRUITING

Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology

Luoyang, Henan, China

Site Status NOT_YET_RECRUITING

Shangqiu First People's Hospital

Shangqiu, Henan, China

Site Status NOT_YET_RECRUITING

Wuhan Mental Health Center

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

Site Status RECRUITING

Nanzhang People's Hospital

Xianyang, Hubei, China

Site Status NOT_YET_RECRUITING

Zhuzhou Central Hospital

Zhuzhou, Hunan, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Inner Mongolia Minzu University

Wuzhou, Inner Mongolia, China

Site Status RECRUITING

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Jinggangshan University

Ji’an, Jiangxi, China

Site Status NOT_YET_RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangx, China

Site Status RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangx, China

Site Status NOT_YET_RECRUITING

Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan

Changzhi, Shanxi, China

Site Status NOT_YET_RECRUITING

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status NOT_YET_RECRUITING

The Hospital of Shanxi University of Chinese Medicine

Taiyuan, Shanxi, China

Site Status RECRUITING

Xi'an People's Hospital (Xi'an Fourth Hospital)

Xi’an, Shanxi, China

Site Status RECRUITING

The First Affiliated Hospital of Xi'an Medical University

Xi’an, Shanxi, China

Site Status RECRUITING

The General Hospital of Western Theater Command PLA

Chengdu, Sichuan, China

Site Status NOT_YET_RECRUITING

Guang'an People's Hospital

Guang’an, Sichuan, China

Site Status NOT_YET_RECRUITING

The People's Hospital of Leshan

Leshan, Sichuan, China

Site Status RECRUITING

Tianjin Binhai New Area Dagang Hospital

Binhai, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

Tianjing Medical University Cancer Institute & Hospital

Dayingmen, Tianjin Municipality, China

Site Status RECRUITING

Tianjin Beichen Hospital

Guoyuan Xincun, Tianjin Municipality, China

Site Status NOT_YET_RECRUITING

The First People's Hospital of Kashgar Prefecture

Kashgar, Xinjiang Uygur Autonomous Region, China

Site Status NOT_YET_RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

Qunjing Hospital of Traditional Chinese Medicine

Qujing, Yunnan, China

Site Status NOT_YET_RECRUITING

Hwa Mei Hospital,University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jiahui Zhang

Role: CONTACT

13049139791

Facility Contacts

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Hui Xu

Role: primary

13693568626

Wenming Wang

Role: primary

13996856392

Xiaoli Zhang

Role: primary

13504549189

Yingping Cao

Role: primary

13365910806

Falin Chen

Role: primary

13600807079

Yan Chen

Role: primary

13905010494

Liqiong Yao

Role: primary

13919300448

Gechong Yong

Role: primary

13919309189

Tian Cai

Role: primary

13106598603

Minmin Li

Role: primary

18903078510

Zhaofan Luo

Role: primary

18002295130

Kang Chen

Role: primary

18898389835

Li Xie

Role: primary

13737089977

Yulin Yuan

Role: primary

13878813926

Minzhong Tang

Role: primary

13481411516

Wei Wang

Role: primary

18786126238

Hai Huang

Role: primary

18985111828

Xiang Wu

Role: primary

13337600255

Dejun Yun

Role: primary

13304690977

Yingyu Jin

Role: primary

13796029276

Haiyan Gao

Role: primary

15545545606

Jinyu Yang

Role: primary

13763665650

Wenxiu Liu

Role: primary

15904526839

Zhanjun Zhang

Role: primary

13939926329

Tao Jiang

Role: primary

13837988831

Weibing Yin

Role: primary

13937057566

Xiaoliang Zhou

Role: primary

18108650781

Zhengjiang Cheng

Role: primary

15207275328

Xuesheng Li

Role: primary

15871057798

Zuiming Jiang

Role: primary

13873381276

Guoli Liu

Role: primary

15247519335

Hongyu Huang

Role: primary

13861740103

Honghou Dai

Role: primary

13807968267

Tianyu Zhong

Role: primary

15279799667

Xiaozhong Wang

Role: primary

13576041466

Jufen Ma

Role: primary

15935530258

Kunping Guan

Role: primary

13700514558

Yuanyuan Pan

Role: primary

13934151016

Hongli Liu

Role: primary

Zhuo Li

Role: primary

13363963035

Yuan Liu

Role: primary

15102813601

Yuanjiu Xu

Role: primary

15308287599

Yin Xiang

Role: primary

15608139066

Heng Zhang

Role: primary

13132181211

Li Ren

Role: primary

18622221306

Kai Chen

Role: primary

18630922553

Aimin Xu

Role: primary

18909981658

Yong Duan

Role: primary

13808706308

Fuxing Zhang

Role: primary

13988901090

Yufeng Liao

Role: primary

13566017561

References

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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.

Reference Type BACKGROUND
PMID: 30150716 (View on PubMed)

Other Identifiers

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CALM2101

Identifier Type: -

Identifier Source: org_study_id

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