Essential HypertensionNCT05638269
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
An observational study of Essential Hypertension and Liver Cancer, run by Zhujiang Hospital at 50 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Liver Cancer, Nasopharyngeal Cancer
- How many people
- 12,000 participants
- Where
- 50 sitesChina
- Study dates
- 1 Mar 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- aged 18-75 years;
- living in the province where the hospital is located in the last three years;
- with a medical diagnosis of one of the target diseases;
- willing to provide written informed consent.
Who cannot join
- female in pregnancy or lactation(unless the subject is pregnant women);
- with medical diagnoses of other serious illnesses;
- with a history of bariatric surgery or intestinal resection, except for appendectomy；
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
China50 sites, 50 recruiting
- Not yet recruiting
Tianjin Binhai New Area Dagang Hospital
Binhai, Tianjin Municipality, 300270
Heng Zhang, 13132181211
- Not yet recruiting
Chang Zhi Yi Xue Yuan Fu Shu He Ji Yi Yuan
Changzhi, Shanxi, 046011
Jufen Ma, 15935530258
- Not yet recruiting
Emergency General Hospital
Chaoyang, Beijing Municipality, 100028
Hui Xu, 13693568626
- Not yet recruiting
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, 610083
Yuan Liu, 15102813601
- Not yet recruiting
Daqing People's Hospital（The Fifth Affiliated Hospital of Harbin Medical University）
Daqing, Heilongjiang, 163316
Dejun Yun, 13304690977
- Recruiting
Tianjing Medical University Cancer Institute & Hospital
Dayingmen, Tianjin Municipality, 300060
Li Ren, 18622221306
- Recruiting
The Sixth Affiliated Hospital of South China University of Technology (Foshan Nanhai District People's Hospital )
Foshan, Guangdong, 528200
Tian Cai, 13106598603
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Yingping Cao, 13365910806
- Not yet recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Falin Chen, 13600807079
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yan Chen, 13905010494
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangx, 341000
Tianyu Zhong, 15279799667
- Not yet recruiting
Guang'an People's Hospital
Guang’an, Sichuan, 638099
Yuanjiu Xu, 15308287599
- Recruiting
The First Affiliated Hospital of Jinan University（Guangzhou Overseas Chinese Hospital ）
Guangzhou, Guangdong, 510600
Minmin Li, 18903078510
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
Wei Wang, 18786126238
- Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Hai Huang, 18985111828
- Not yet recruiting
Tianjin Beichen Hospital
Guoyuan Xincun, Tianjin Municipality, 300400
Kai Chen, 18630922553
- Not yet recruiting
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan, 570100
Xiang Wu, 13337600255
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150007
Yingyu Jin, 13796029276
- Not yet recruiting
The Sixth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150088
Haiyan Gao, 15545545606
- Not yet recruiting
Affiliated Hospital of Jinggangshan University
Ji’an, Jiangxi, 343000
Honghou Dai, 13807968267
- Not yet recruiting
Jixi Ji Mine Hospital
Jixi, Heilongjiang
Jinyu Yang, 13763665650
- Not yet recruiting
The First People's Hospital of Kashgar Prefecture
Kashgar, Xinjiang Uygur Autonomous Region, 844000
Aimin Xu, 18909981658
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Yong Duan, 13808706308
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Liqiong Yao, 13919300448
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Gechong Yong, 13919309189
- Recruiting
The People's Hospital of Leshan
Leshan, Sichuan, 614000
Yin Xiang, 15608139066
- Not yet recruiting
Luoyang Maternal and Child Health Hospital
Luoyang, Henan, 471000
Zhanjun Zhang, 13939926329
- Not yet recruiting
Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine,Medical College of Henan University of Science and Technology
Luoyang, Henan, 471003
Tao Jiang, 13837988831
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangx, 330000
Xiaozhong Wang, 13576041466
- Not yet recruiting
The People's Hospital Of Nanchuan Chongqing
Nanchuan, Chongqing Municipality, 408400
Wenming Wang, 13996856392
- Not yet recruiting
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007
Li Xie, 13737089977
- Recruiting
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Yulin Yuan, 13878813926
- Not yet recruiting
Hwa Mei Hospital,University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010
Yufeng Liao, 13566017561
- Not yet recruiting
Qiqihar Hospital of Traditional Chinese Medicine
Qiqihar, Heilongjiang, 161005
Wenxiu Liu, 15904526839
- Not yet recruiting
Qunjing Hospital of Traditional Chinese Medicine
Qujing, Yunnan, 655000
Fuxing Zhang, 13988901090
- Not yet recruiting
Shangqiu First People's Hospital
Shangqiu, Henan, 476100
Weibing Yin, 13937057566
- Not yet recruiting
The seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518107
Zhaofan Luo, 18002295130
- Not yet recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Kunping Guan, 13700514558
- Recruiting
The Hospital of Shanxi University of Chinese Medicine
Taiyuan, Shanxi, 030024
Yuanyuan Pan, 13934151016
- Recruiting
Wuzhou Red Cross Hospital
Tongliao, Guangxi, 543002
Minzhong Tang, 13481411516
- Not yet recruiting
Wuhan Mental Health Center
Wuhan, Hubei, 430012
Xiaoliang Zhou, 18108650781
- Not yet recruiting
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, 214002
Hongyu Huang, 13861740103
- Recruiting
Affiliated Hospital of Inner Mongolia Minzu University
Wuzhou, Inner Mongolia, 028000
Guoli Liu, 15247519335
- Recruiting
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi’an, Shanxi, 710004
Hongli Liu
- Recruiting
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077
Zhuo Li, 13363963035
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Zhengjiang Cheng, 15207275328
- Not yet recruiting
Nanzhang People's Hospital
Xianyang, Hubei, 441599
Xuesheng Li, 15871057798
- Not yet recruiting
YongChuan hospital of Chongqing Medical Univeristy
Yongchuan, Chongqing Municipality, 402177
Xiaoli Zhang, 13504549189
- Not yet recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 564000
Kang Chen, 18898389835
- Not yet recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007
Zuiming Jiang, 13873381276
About this study
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.
Read the 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.
- Conditions
- Essential Hypertension, Liver Cancer, Nasopharyngeal Cancer, Pancreatic Cancer, Lung Cancer, Chronic Kidney Diseases
- Being tested
- no intervention
- Keywords
- cardiovascular disease, exctracoonic cancer, nervous system diseases, endocrine diseases, urological diseases, microbial dysbiosis
- Medical subject headings
- Essential Hypertension, Liver Neoplasms, Nasopharyngeal Neoplasms, Pancreatic Neoplasms, Lung Neoplasms, Renal Insufficiency, Chronic, Acute Coronary Syndrome, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Observational studies, no intervention
| Study group | Role | What they receive |
|---|---|---|
| disease group | no intervention Receives: Other: no intervention | |
| control group | no intervention Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (3)
biochemistry
Comparison of serum markers of healthy volunteers and patients with various diseases.
Measured: baseline
metabonomics
Comparison of metabolites of healthy volunteers and patients with various diseases.
Measured: baseline
proteomics
Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yan He, Zhujiang Hospital
- Investigators
- Yan He, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638269
- Sponsor's protocol ID
- CALM2101
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2022
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30150716
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
- ClinicalTrials.gov ID
- NCT05638269
- Acronym / sponsor ID
- CALM2101
- Conditions
- Essential Hypertension, Liver Cancer, Nasopharyngeal Cancer, Pancreatic Cancer, Lung Cancer, Chronic Kidney Diseases
- Keywords
- cardiovascular disease, exctracoonic cancer, nervous system diseases, endocrine diseases, urological diseases, microbial dysbiosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| disease group | – | Other: no interventionno intervention |
| control group | – | Other: no interventionno intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- aged 18-75 years;
- living in the province where the hospital is located in the last three years;
- with a medical diagnosis of one of the target diseases;
- willing to provide written informed consent.
Key exclusion criteria (4 listed)
- female in pregnancy or lactation(unless the subject is pregnant women);
- with medical diagnoses of other serious illnesses;
- with a history of bariatric surgery or intestinal resection, except for appendectomy；
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionObservational studies, no intervention | Other | control group, disease group |
Primary outcome
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.
3 secondary outcomes
biochemistry
Time frame: baseline
metabonomics
Time frame: baseline
proteomics
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 30150716He 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan He study chair
Zhujiang Hospital
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension and Liver Cancer, run by Zhujiang Hospital at 50 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiahui Zhang (13049139791, zjh13049139791@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiome (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638269, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.