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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Essential Hypertension, Liver Cancer, Nasopharyngeal Cancer, Pancreatic Cancer, Lung Cancer, Chronic Kidney Diseases, Acute Coronary Syndrome, Epilepsy, Gastric Cancer, Primary Aldosteronism, Subclinical hypothyroïdism

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| disease group<br>no intervention | Other: no intervention<br>* Observational studies, no intervention<br>|
| control group<br>no intervention | Other: no intervention<br>* Observational studies, no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemistry | Comparison of serum markers of healthy volunteers and patients with various diseases. | baseline | 
| metabonomics | Comparison of metabolites of healthy volunteers and patients with various diseases. | baseline | 
| proteomics | Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, exctracoonic cancer, nervous system diseases, endocrine diseases, urological diseases, microbial dysbiosis