- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2022-03-01
2024-12
2025-12
12000
NCT05638269
Zhujiang Hospital
Zhujiang Hospital
OBSERVATIONAL
A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-09-26 | N/A | 2024-07-26 |
2022-11-25 | N/A | 2024-07-29 |
2022-12-06 | N/A | 2024-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : disease group no intervention | OTHER: no intervention
|
| : control group no intervention | OTHER: no intervention
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jiahui Zhang Phone Number: 13049139791 Email: zjh13049139791@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
