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

July 26, 2024 updated by: Yan He, Zhujiang Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Chaoyang, Beijing, China, 100028
        • Not yet recruiting
        • Emergency General Hospital
        • Contact:
          • Hui Xu
          • Phone Number: 13693568626
    • Chongqing
      • Nanchuan, Chongqing, China, 408400
        • Not yet recruiting
        • The People's Hospital Of Nanchuan Chongqing
        • Contact:
          • Wenming Wang
          • Phone Number: 13996856392
      • Yongchuan, Chongqing, China, 402177
        • Not yet recruiting
        • YongChuan hospital of Chongqing Medical Univeristy
        • Contact:
          • Xiaoli Zhang
          • Phone Number: 13504549189
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Yingping Cao
          • Phone Number: 13365910806
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Provincial Hospital
        • Contact:
          • Falin Chen
          • Phone Number: 13600807079
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Cancer Hospital
        • Contact:
          • Yan Chen
          • Phone Number: 13905010494
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First Hospital of Lanzhou University
        • Contact:
          • Liqiong Yao
          • Phone Number: 13919300448
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
          • Gechong Yong
          • Phone Number: 13919309189
    • Guangdong
      • Foshan, Guangdong, China, 528200
        • Recruiting
        • The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
        • Contact:
          • Tian Cai
          • Phone Number: 13106598603
      • Guangzhou, Guangdong, China, 510600
        • Recruiting
        • The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
        • Contact:
          • Minmin Li
          • Phone Number: 18903078510
      • Shenzhen, Guangdong, China, 518107
        • Not yet recruiting
        • The Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:
          • Zhaofan Luo
          • Phone Number: 18002295130
      • Zhongshan, Guangdong, China, 564000
        • Not yet recruiting
        • Zhongshan City People's Hospital
        • Contact:
          • Kang Chen
          • Phone Number: 18898389835
    • Guangxi
      • Nanning, Guangxi, China, 530007
        • Not yet recruiting
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Li Xie
          • Phone Number: 13737089977
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • Yulin Yuan
          • Phone Number: 13878813926
      • Tongliao, Guangxi, China, 543002
        • Recruiting
        • Wuzhou Red Cross Hospital
        • Contact:
          • Minzhong Tang
          • Phone Number: 13481411516
    • Guizhou
      • Guiyang, Guizhou, China, 550001
        • Not yet recruiting
        • The Affiliated Cancer Hospital of Guizhou Medical University
        • Contact:
          • Wei Wang
          • Phone Number: 18786126238
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
          • Hai Huang
          • Phone Number: 18985111828
    • Hainan
      • Haikou, Hainan, China, 570100
        • Not yet recruiting
        • Hainan Traditional Chinese Medicine Hospital
        • Contact:
          • Xiang Wu
          • Phone Number: 13337600255
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163316
        • Not yet recruiting
        • Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
        • Contact:
          • Dejun Yun
          • Phone Number: 13304690977
      • Harbin, Heilongjiang, China, 150007
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
          • Yingyu Jin
          • Phone Number: 13796029276
      • Harbin, Heilongjiang, China, 150088
        • Not yet recruiting
        • The Sixth Affiliated Hospital of Harbin Medical University
        • Contact:
          • Haiyan Gao
          • Phone Number: 15545545606
      • Jixi, Heilongjiang, China
        • Not yet recruiting
        • Jixi Ji Mine Hospital
        • Contact:
          • Jinyu Yang
          • Phone Number: 13763665650
      • Qiqihar, Heilongjiang, China, 161005
        • Not yet recruiting
        • Qiqihar Hospital of Traditional Chinese Medicine
        • Contact:
          • Wenxiu Liu
          • Phone Number: 15904526839
    • Henan
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Maternal and Child Health Hospital
        • Contact:
          • Zhanjun Zhang
          • Phone Number: 13939926329
      • Luoyang, Henan, China, 471003
        • Not yet recruiting
        • Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
        • Contact:
          • Tao Jiang
          • Phone Number: 13837988831
      • Shangqiu, Henan, China, 476100
        • Not yet recruiting
        • Shangqiu First People's Hospital
        • Contact:
          • Weibing Yin
          • Phone Number: 13937057566
    • Hubei
      • Wuhan, Hubei, China, 430012
        • Not yet recruiting
        • Wuhan Mental Health Center
        • Contact:
          • Xiaoliang Zhou
          • Phone Number: 18108650781
      • Xiangyang, Hubei, China, 441021
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
          • Zhengjiang Cheng
          • Phone Number: 15207275328
      • Xianyang, Hubei, China, 441599
        • Not yet recruiting
        • Nanzhang People's Hospital
        • Contact:
          • Xuesheng Li
          • Phone Number: 15871057798
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Not yet recruiting
        • Zhuzhou Central Hospital
        • Contact:
          • Zuiming Jiang
          • Phone Number: 13873381276
    • Inner Mongolia Autonomous Region
      • Wuzhou, Inner Mongolia Autonomous Region, China, 028000
        • Recruiting
        • Affiliated Hospital of Inner Mongolia Minzu University
        • Contact:
          • Guoli Liu
          • Phone Number: 15247519335
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Not yet recruiting
        • Wuxi No.2 People's Hospital
        • Contact:
          • Hongyu Huang
          • Phone Number: 13861740103
    • Jiangx
      • Ganzhou, Jiangx, China, 341000
        • Recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Tianyu Zhong
          • Phone Number: 15279799667
      • Nanchang, Jiangx, China, 330000
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Xiaozhong Wang
          • Phone Number: 13576041466
    • Jiangxi
      • Ji'an, Jiangxi, China, 343000
        • Not yet recruiting
        • Affiliated Hospital of Jinggangshan University
        • Contact:
          • Honghou Dai
          • Phone Number: 13807968267
    • Shanxi
      • Changzhi, Shanxi, China, 046011
        • Not yet recruiting
        • Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
        • Contact:
          • Jufen Ma
          • Phone Number: 15935530258
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • The Second Hospital of Shanxi Medical University
        • Contact:
          • Kunping Guan
          • Phone Number: 13700514558
      • Taiyuan, Shanxi, China, 030024
        • Recruiting
        • The Hospital of Shanxi University of Chinese Medicine
        • Contact:
          • Yuanyuan Pan
          • Phone Number: 13934151016
      • Xi'an, Shanxi, China, 710004
        • Recruiting
        • Xi'an People's Hospital (Xi'an Fourth Hospital)
        • Contact:
          • Hongli Liu
      • Xi'an, Shanxi, China, 710077
        • Recruiting
        • The First Affiliated Hospital of Xi'an Medical University
        • Contact:
          • Zhuo Li
          • Phone Number: 13363963035
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • Not yet recruiting
        • The General Hospital of Western Theater Command PLA
        • Contact:
          • Yuan Liu
          • Phone Number: 15102813601
      • Guang'an, Sichuan, China, 638099
        • Not yet recruiting
        • Guang'an People's Hospital
        • Contact:
          • Yuanjiu Xu
          • Phone Number: 15308287599
      • Leshan, Sichuan, China, 614000
        • Recruiting
        • The people's hospital of Leshan
        • Contact:
          • Yin Xiang
          • Phone Number: 15608139066
    • Tianjin
      • Beichen, Tianjin, China, 300400
        • Not yet recruiting
        • Tianjin Beichen Hospital
        • Contact:
          • Kai Chen
          • Phone Number: 18630922553
      • Binhai, Tianjin, China, 300270
        • Not yet recruiting
        • Tianjin Binhai New Area Dagang Hospital
        • Contact:
          • Heng Zhang
          • Phone Number: 13132181211
      • Hexi, Tianjin, China, 300060
        • Recruiting
        • Tianjing Medical University Cancer Institute & Hospital
        • Contact:
          • Li Ren
          • Phone Number: 18622221306
    • Xinjiang Uygur Autonomous Region
      • Kashgar, Xinjiang Uygur Autonomous Region, China, 844000
        • Not yet recruiting
        • The First People's Hospital of Kashgar Prefecture
        • Contact:
          • Aimin Xu
          • Phone Number: 18909981658
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Yong Duan
          • Phone Number: 13808706308
      • Qujing, Yunnan, China, 655000
        • Not yet recruiting
        • Qunjing Hospital of Traditional Chinese Medicine
        • Contact:
          • Fuxing Zhang
          • Phone Number: 13988901090
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Not yet recruiting
        • Hwa Mei Hospital,University of Chinese Academy of sciences
        • Contact:
          • Yufeng Liao
          • Phone Number: 13566017561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
disease group
no intervention
Other: no intervention
Observational studies, no intervention
control group
no intervention
Other: no intervention
Observational studies, no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
microbiome
Time Frame: 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.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
biochemistry
Time Frame: baseline
Comparison of serum markers of healthy volunteers and patients with various diseases.
baseline
metabonomics
Time Frame: baseline
Comparison of metabolites of healthy volunteers and patients with various diseases.
baseline
proteomics
Time Frame: baseline
Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Natural Science Foundation of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yan He, Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CALM2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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