NCT05638269

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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
• Acute Coronary Syndrome
• Epilepsy
• Gastric Cancer
• Primary Aldosteronism
• Subclinical hypothyroïdism

Interventions

Type	Name	Description
OTHER	no intervention	Observational studies, no intervention

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-12-06
• Last updated: 2024-07-29

Locations

50 sites across 1 country: China