Regional variation limits applications of healthy gut microbiome reference ranges and disease models.
Yan He, Wei Wu, Hui-Min Zheng...
https://pubmed.ncbi.nlm.nih.gov/30150716Actively Recruiting
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID05638269
Features of the Gut Microbiota in Patients With Critical Chronic Diseases: A Multicentre Observational Study in China
Led by Zhujiang Hospital · Updated on 2024-07-29
12000
Participants Needed
50
Research Sites
52 weeks
Total Duration
On this page
Sponsors
Z
Zhujiang Hospital
Lead Sponsor
N
National Natural Science Foundation of China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the gut microbiome in people with various serious 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. The study aims to better understand how the gut microbiota differs across these diseases and regions and to explore the impact of these differences on microbiota-based diagnostic models. This multicenter observational study addresses the challenges caused by variability in previous research and seeks to validate microbial biomarkers in large population-based groups. Participants include patients diagnosed with one of the target diseases and age- and sex-matched healthy controls. Each participant will provide information on demographics, body measurements, lifestyle, diet, medications, diseases, and biochemistry. Samples of feces, saliva, urine, and blood will be collected from all participants. No treatments or interventions are administered, as this is an observational study. The study is designed to enroll 500 patients and 500 controls for each disease group. Participants will be involved in a one-time assessment where researchers will collect biological samples and detailed health and lifestyle information. The main outcome measure is the baseline microbiome profile, with additional assessments including baseline biochemistry, metabonomics, and proteomics. The study includes adults aged 18 to 75 years living in the hospital's province for at least three years. The entire study aims to improve understanding of gut microbiota patterns across critical chronic diseases and their diagnostic potential.
CONDITIONS
Brief Title
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Living in the hospital's province for the past three years
- Diagnosed with one of the target diseases
- Willing to provide written informed consent
You will not qualify if you...
- Female who is pregnant or breastfeeding
- Diagnosed with other serious illnesses
- History of bariatric surgery or intestinal resection, except appendectomy
- Treated with antibiotics, metformin, statins, acid inhibitors, or probiotics in the past month
- Consumed yogurt more than 3 times in the past month
- Heavy alcohol consumption (more than 4 taels of liquor or 1000ml of beer)
- Frequent alcohol consumption in the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - One-time assessment
Participants provide information about their demography, body measurements, lifestyle, diet, medication, diseases, and biochemistry, and biological samples including feces, saliva, urine, and blood are collected for analysis.
1 visit (in-person)
Long-term Monitoring
Duration - Ongoing during study period
Participants who undergo routine care are observed to compare microbiome signatures among different critical chronic diseases and controls.
Trial Site Locations
Total: 50 locations
1
Emergency General Hospital
Chaoyang, Beijing Municipality, China, 100028
Not Yet Recruiting
2
The People's Hospital Of Nanchuan Chongqing
Nanchuan, Chongqing Municipality, China, 408400
Not Yet Recruiting
3
YongChuan hospital of Chongqing Medical Univeristy
Yongchuan, Chongqing Municipality, China, 402177
Not Yet Recruiting
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
5
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
7
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Not Yet Recruiting
9
The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
Foshan, Guangdong, China, 528200
Actively Recruiting
10
The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
Guangzhou, Guangdong, China, 510600
Actively Recruiting
11
The seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China, 518107
Not Yet Recruiting
12
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 564000
Not Yet Recruiting
13
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530007
Not Yet Recruiting
14
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
15
Wuzhou Red Cross Hospital
Tongliao, Guangxi, China, 543002
Actively Recruiting
16
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550001
Not Yet Recruiting
17
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
18
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan, China, 570100
Not Yet Recruiting
19
Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
Daqing, Heilongjiang, China, 163316
Not Yet Recruiting
20
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150007
Actively Recruiting
21
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150088
Not Yet Recruiting
22
Jixi Ji Mine Hospital
Jixi, Heilongjiang, China
Not Yet Recruiting
23
Qiqihar Hospital of Traditional Chinese Medicine
Qiqihar, Heilongjiang, China, 161005
Not Yet Recruiting
24
Luoyang Maternal and Child Health Hospital
Luoyang, Henan, China, 471000
Not Yet Recruiting
25
Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Not Yet Recruiting
26
Shangqiu First People's Hospital
Shangqiu, Henan, China, 476100
Not Yet Recruiting
27
Wuhan Mental Health Center
Wuhan, Hubei, China, 430012
Not Yet Recruiting
28
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Actively Recruiting
29
Nanzhang People's Hospital
Xianyang, Hubei, China, 441599
Not Yet Recruiting
30
Zhuzhou Central Hospital
Zhuzhou, Hunan, China, 412007
Not Yet Recruiting
31
Affiliated Hospital of Inner Mongolia Minzu University
Wuzhou, Inner Mongolia, China, 028000
Actively Recruiting
32
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China, 214002
Not Yet Recruiting
33
Affiliated Hospital of Jinggangshan University
Ji’an, Jiangxi, China, 343000
Not Yet Recruiting
34
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangx, China, 341000
Actively Recruiting
35
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, China, 330000
Not Yet Recruiting
36
Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
Changzhi, Shanxi, China, 046011
Not Yet Recruiting
37
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
38
The Hospital of Shanxi University of Chinese Medicine
Taiyuan, Shanxi, China, 030024
Actively Recruiting
39
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi’an, Shanxi, China, 710004
Actively Recruiting
40
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China, 710077
Actively Recruiting
41
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China, 610083
Not Yet Recruiting
42
Guang'an People's Hospital
Guang’an, Sichuan, China, 638099
Not Yet Recruiting
43
The People's Hospital of Leshan
Leshan, Sichuan, China, 614000
Actively Recruiting
44
Tianjin Binhai New Area Dagang Hospital
Binhai, Tianjin Municipality, China, 300270
Not Yet Recruiting
45
Tianjing Medical University Cancer Institute & Hospital
Dayingmen, Tianjin Municipality, China, 300060
Actively Recruiting
46
Tianjin Beichen Hospital
Guoyuan Xincun, Tianjin Municipality, China, 300400
Not Yet Recruiting
47
The First People's Hospital of Kashgar Prefecture
Kashgar, Xinjiang Uygur Autonomous Region, China, 844000
Not Yet Recruiting
48
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650032
Actively Recruiting
49
Qunjing Hospital of Traditional Chinese Medicine
Qujing, Yunnan, China, 655000
Not Yet Recruiting
50
Hwa Mei Hospital,University of Chinese Academy of Sciences
Ningbo, Zhejiang, China, 315010
Not Yet Recruiting
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Research Team
J
Jiahui Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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