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

• Sponsor: Zhujiang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05638269
• Collaborator: National Natural Science Foundation of China (Other)
• Enrollment: 12,000
• Locations: 50
• Anticipated Duration (Months): 45
• Patients Per Site: 240
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension; Liver Cancer; Nasopharyngeal Cancer; Pancreatic Cancer; Lung Cancer; Chronic Kidney Diseases; Acute Coronary Syndrome; Epilepsy; Gastric Cancer; Primary Aldosteronism; Subclinical hypothyroïdism	Other: no intervention

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 Design

• Study Type: Observational
• Anticipated Enrollment: 12000 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
• Actual Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
disease group no intervention	Other: no intervention; Observational studies, no intervention
control group no intervention	Other: no intervention; Observational studies, no intervention

Outcome Measures

Primary Outcome Measures

1. microbiome [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.

Secondary Outcome Measures

1. biochemistry [baseline]

   Comparison of serum markers of healthy volunteers and patients with various diseases.

2. metabonomics [baseline]

   Comparison of metabolites of healthy volunteers and patients with various diseases.

3. proteomics [baseline]

   Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emergency General Hospital	Chaoyang	Beijing	China	100028
2	The People's Hospital Of Nanchuan Chongqing	Nanchuan	Chongqing	China	408400
3	YongChuan hospital of Chongqing Medical Univeristy	Yongchuan	Chongqing	China	402177
4	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001
5	Fujian Provincial Hospital	Fuzhou	Fujian	China	350001
6	Fujian Cancer Hospital	Fuzhou	Fujian	China	350014
7	The First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
8	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730030
9	The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )	Foshan	Guangdong	China	528200
10	The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）	Guangzhou	Guangdong	China	510600
11	The seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong	China	518107
12	Zhongshan City People's Hospital	Zhongshan	Guangdong	China	564000
13	The Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi	China	530007
14	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi	China	530021
15	Wuzhou Red Cross Hospital	Tongliao	Guangxi	China	543002
16	The Affiliated Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou	China	550001
17	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou	China	550004
18	Hainan Traditional Chinese Medicine Hospital	Haikou	Hainan	China	570100
19	Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）	Daqing	Heilongjiang	China	163316
20	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150007
21	The Sixth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150088
22	Jixi Ji Mine Hospital	Jixi	Heilongjiang	China
23	Qiqihar Hospital of Traditional Chinese Medicine	Qiqihar	Heilongjiang	China	161005
24	Luoyang Maternal and Child Health Hospital	Luoyang	Henan	China	471000
25	Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology	Luoyang	Henan	China	471003
26	Shangqiu First People's Hospital	Shangqiu	Henan	China	476100
27	Wuhan Mental Health Center	Wuhan	Hubei	China	430012
28	Xiangyang Central Hospital	Xiangyang	Hubei	China	441021
29	Nanzhang People's Hospital	Xianyang	Hubei	China	441599
30	Zhuzhou Central Hospital	Zhuzhou	Hunan	China	412007
31	Affiliated Hospital of Inner Mongolia Minzu University	Wuzhou	Inner Mongolia Autonomous Region	China	028000
32	Wuxi No.2 People's Hospital	Wuxi	Jiangsu	China	214002
33	Affiliated Hospital of Jinggangshan University	Ji'an	Jiangxi	China	343000
34	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangx	China	341000
35	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangx	China	330000
36	Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan	Changzhi	Shanxi	China	046011
37	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
38	The Hospital of Shanxi University of Chinese Medicine	Taiyuan	Shanxi	China	030024
39	Xi'an People's Hospital (Xi'an Fourth Hospital)	Xi'an	Shanxi	China	710004
40	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shanxi	China	710077
41	The General Hospital of Western Theater Command PLA	Chengdu	Sichuan	China	610083
42	Guang'an People's Hospital	Guang'an	Sichuan	China	638099
43	The People's Hospital of Leshan	Leshan	Sichuan	China	614000
44	Tianjin Beichen Hospital	Beichen	Tianjin	China	300400
45	Tianjin Binhai New Area Dagang Hospital	Binhai	Tianjin	China	300270
46	Tianjing Medical University Cancer Institute & Hospital	Hexi	Tianjin	China	300060
47	The First People's Hospital of Kashgar Prefecture	Kashgar	Xinjiang Uygur Autonomous Region	China	844000
48	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan	China	650032
49	Qunjing Hospital of Traditional Chinese Medicine	Qujing	Yunnan	China	655000
50	Hwa Mei Hospital,University of Chinese Academy of Sciences	Ningbo	Zhejiang	China	315010

Sponsors and Collaborators

• Zhujiang Hospital
• National Natural Science Foundation of China

Investigators

• Study Chair: Yan He, Zhujiang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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;:

• Responsible Party: Yan He, Professor, Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT05638269
• Other Study ID Numbers: CALM2101
• First Posted: Dec 6, 2022
• Last Update Posted: Dec 21, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yan He, Professor, Zhujiang Hospital: cardiovascular disease; exctracoonic cancer; nervous system diseases; endocrine diseases; urological diseases; microbial dysbiosis
• Additional relevant MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Kidney Diseases; Renal Insufficiency, Chronic; Acute Coronary Syndrome; Essential Hypertension; Hypothyroidism; Hyperaldosteronism; Chronic Disease

Study Results

No Results Posted as of Dec 21, 2022