Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05638269
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2022-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Sponsor:
Zhujiang Hospital
Organization:
Study Overview
Official Title:
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: