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

Last updated: July 26, 2024
Sponsor: Zhujiang Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Liver Cancer

Nasopharyngeal Cancer

Treatment

no intervention

Clinical Study ID

NCT05638269
CALM2101
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 forappendectomy;

  4. individual who was treated with drugs in the preceding 1 month, includingantibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics;individuals having consumed yogurt more than 3 times in the preceding 1 month; heavydrinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequentalcohol consumers who have drunk per week in the last month.

Study Design

Total Participants: 12000
Treatment Group(s): 1
Primary Treatment: no intervention
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Emergency General Hospital

    Chaoyang, Beijing 100028
    China

    Site Not Available

  • The People's Hospital Of Nanchuan Chongqing

    Nanchuan, Chongqing 408400
    China

    Site Not Available

  • YongChuan hospital of Chongqing Medical Univeristy

    Yongchuan, Chongqing 402177
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

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

    Foshan, Guangdong 528200
    China

    Active - Recruiting

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

    Guangzhou, Guangdong 510600
    China

    Active - Recruiting

  • The seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong 518107
    China

    Site Not Available

  • Zhongshan City People's Hospital

    Zhongshan, Guangdong 564000
    China

    Site Not Available

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530007
    China

    Site Not Available

  • Wuzhou Red Cross Hospital

    Tongliao, Guangxi 543002
    China

    Active - Recruiting

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou 550001
    China

    Site Not Available

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550004
    China

    Active - Recruiting

  • Hainan Traditional Chinese Medicine Hospital

    Haikou, Hainan 570100
    China

    Site Not Available

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

    Daqing, Heilongjiang 163316
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150007
    China

    Active - Recruiting

  • The Sixth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150088
    China

    Site Not Available

  • Jixi Ji Mine Hospital

    Jixi, Heilongjiang
    China

    Site Not Available

  • Qiqihar Hospital of Traditional Chinese Medicine

    Qiqihar, Heilongjiang 161005
    China

    Site Not Available

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

    Luoyang, Henan 471003
    China

    Site Not Available

  • Luoyang Maternal and Child Health Hospital

    Luoyang, Henan 471000
    China

    Site Not Available

  • Shangqiu First People's Hospital

    Shangqiu, Henan 476100
    China

    Site Not Available

  • Wuhan Mental Health Center

    Wuhan, Hubei 430012
    China

    Site Not Available

  • Xiangyang Central Hospital

    Xiangyang, Hubei 441021
    China

    Active - Recruiting

  • Nanzhang People's Hospital

    Xianyang, Hubei 441599
    China

    Site Not Available

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412007
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Minzu University

    Wuzhou, Inner Mongolia Autonomous Region 028000
    China

    Active - Recruiting

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu 214002
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangx 341000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangx 330000
    China

    Site Not Available

  • Affiliated Hospital of Jinggangshan University

    Ji'an, Jiangxi 343000
    China

    Site Not Available

  • Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan

    Changzhi, Shanxi 046011
    China

    Site Not Available

  • The Hospital of Shanxi University of Chinese Medicine

    Taiyuan, Shanxi 030024
    China

    Active - Recruiting

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shanxi 710077
    China

    Active - Recruiting

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

    Xi'an, Shanxi 710004
    China

    Active - Recruiting

  • The General Hospital of Western Theater Command PLA

    Chengdu, Sichuan 610083
    China

    Site Not Available

  • Guang'an People's Hospital

    Guang'an, Sichuan 638099
    China

    Site Not Available

  • The People's Hospital of Leshan

    Leshan, Sichuan 614000
    China

    Active - Recruiting

  • Tianjin Beichen Hospital

    Beichen, Tianjin 300400
    China

    Site Not Available

  • Tianjin Binhai New Area Dagang Hospital

    Binhai, Tianjin 300270
    China

    Site Not Available

  • Tianjing Medical University Cancer Institute & Hospital

    Hexi, Tianjin 300060
    China

    Active - Recruiting

  • The First People's Hospital of Kashgar Prefecture

    Kashgar, Xinjiang Uygur Autonomous Region 844000
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Qunjing Hospital of Traditional Chinese Medicine

    Qujing, Yunnan 655000
    China

    Site Not Available

  • Hwa Mei Hospital,University of Chinese Academy of Sciences

    Ningbo, Zhejiang 315010
    China

    Site Not Available

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