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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05071742
Other study ID # SAHoWMU-CR2021-01-206
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2021
Est. completion date December 31, 2024

Study information

Verified date November 2021
Source Second Affiliated Hospital of Wenzhou Medical University
Contact Yi Jiang, PHD
Phone +86 13676715542
Email wzjiangyi@yeah.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Chinese Han population, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.


Description:

The pathogenesis of IBD is still unclear, and the disease characteristics of IBD patients are affected by genetic susceptibility genes. Therefore, this study aims to explore the relationship between genetic susceptibility genes of IBD and the pathogenesis of IBD in Han Chinese, in order to clarify the pathogenesis of IBD and provide basis for individualized treatment of IBD.In this study, 5ml peripheral venous blood was drawn from IBD patients and normal controls for gene testing.To investigate the relationship between polymorphisms of TRAIL, ITGA4, ICAM1, ITGA4, ICAM1, LTA, FCGR3A, TRAP1, TNFRSF1B, CDKN2B-AS1 and susceptibility to IBD in Chinese Han population.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Confirmed IBD patients were collected from the Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University.According to the consensus of "Diagnosis and treatment of inflammatory bowel disease" formulated by Chinese Society of Gastroenterology, the diagnosis of IBD was established by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.During the same period, 476 healthy subjects were collected from the physical examination center of our hospital as the normal control group Exclusion Criteria: - Active infection, malignant tumor, congestive heart failure, demyelination of nervous system, allergy to rat derived protein components, etc All subjects were excluded from infectious diarrhea, ischemic enteropathy, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis by clinical examination before inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
2ml peripheral venous blood was collected to detect genetic genes
Extraction of whole genome DNA: 2 mL of peripheral fasting venous blood was extracted, and edTA disodium was anticoagulant.The whole-genome DNA was extracted strictly in accordance with the instructions of the blood genomic DNA extraction kit (Beijing Tiagen Biochemical Technology Co., LTD., China), and the DNA concentration and purity were detected by nanodrop-1000 spectrophotometer (Thermo, USA). The DNA was diluted to 10 ng/µL and stored in a refrigerator at -80? for future use. (2) Primer design and synthesis: (3) Gene polymorphism detection 4) Resin purification 5) Spot chip and mass spectrometry detection

Locations

Country Name City State
China The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of genetic susceptibility genes to inflammatory bowel disease in Chinese Han population The difference in mutation frequency of different gene loci between IBD patients and control group was compared. 2021-2024
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