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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638269
• Other study ID #: CALM2101
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: December 2022
• Source: Zhujiang Hospital
• Contact: Jiahui Zhang
• Phone: 13049139791
• Email: zjh13049139791[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chronic Disease
• Chronic Kidney Diseases
• Epilepsy
• Essential Hypertension
• Gastric Cancer
• Hyperaldosteronism
• Hypothyroidism
• Kidney Diseases
• Liver Cancer
• Lung Cancer
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Pancreatic Cancer
• Primary Aldosteronism
• Renal Insufficiency, Chronic
• Subclinical hypothyroïdism

Intervention

Other:
• no intervention
Observational studies, no intervention

Locations

Country	Name	City	State
China	Tianjin Beichen Hospital	Beichen	Tianjin
China	Tianjin Binhai New Area Dagang Hospital	Binhai	Tianjin
China	Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan	Changzhi	Shanxi
China	Emergency General Hospital	Chaoyang	Beijing
China	The General Hospital of Western Theater Command PLA	Chengdu	Sichuan
China	Daqing People's Hospital(The Fifth Affiliated Hospital of Harbin Medical University)	Daqing	Heilongjiang
China	The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )	Foshan	Guangdong
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangx
China	Guang'an People's Hospital	Guang'an	Sichuan
China	The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital )	Guangzhou	Guangdong
China	The Affiliated Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Hainan Traditional Chinese Medicine Hospital	Haikou	Hainan
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Sixth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Tianjing Medical University Cancer Institute & Hospital	Hexi	Tianjin
China	Affiliated Hospital of Jinggangshan University	Ji'an	Jiangxi
China	Jixi Ji Mine Hospital	Jixi	Heilongjiang
China	The First People's Hospital of Kashgar Prefecture	Kashgar	Xinjiang Uygur Autonomous Region
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The People's Hospital of Leshan	Leshan	Sichuan
China	Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology	Luoyang	Henan
China	Luoyang Maternal and Child Health Hospital	Luoyang	Henan
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangx
China	The People's Hospital Of Nanchuan Chongqing	Nanchuan	Chongqing
China	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	The Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Hwa Mei Hospital,University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Qiqihar Hospital of Traditional Chinese Medicine	Qiqihar	Heilongjiang
China	Qunjing Hospital of Traditional Chinese Medicine	Qujing	Yunnan
China	Shangqiu First People's Hospital	Shangqiu	Henan
China	The seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong
China	The Hospital of Shanxi University of Chinese Medicine	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Wuzhou Red Cross Hospital	Tongliao	Guangxi
China	Wuhan Mental Health Center	Wuhan	Hubei
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	Affiliated Hospital of Inner Mongolia Minzu University	Wuzhou	Inner Mongolia Autonomous Region
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shanxi
China	Xi'an People's Hospital (Xi'an Fourth Hospital)	Xi'an	Shanxi
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	Nanzhang People's Hospital	Xianyang	Hubei
China	YongChuan hospital of Chongqing Medical Univeristy	Yongchuan	Chongqing
China	Zhongshan City People's Hospital	Zhongshan	Guangdong
China	Zhuzhou Central Hospital	Zhuzhou	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & 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. Erratum In: Nat Med. 2018 Sep 24;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	biochemistry	Comparison of serum markers of healthy volunteers and patients with various diseases.	baseline
Secondary	metabonomics	Comparison of metabolites of healthy volunteers and patients with various diseases.	baseline
Secondary	proteomics	Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry.	baseline