Correlation of Genetic Susceptibility Genes to Inflammatory Bowel Disease in Chinese Han Population (CGSGIBDCHP)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease; Gene Abnormality; Chinese
• Intervention / Treatment: Genetic: 2ml peripheral venous blood was collected to detect genetic genes

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yi Jiang, PHD; Phone Number: +86 13676715542; Email: wzjiangyi@yeah.net

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Xiaoxiao Shao, PHD; Phone Number: +8615967465468; Email: 494311941@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

IBD patients or healthy controls who met the inclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD group; According to the consensus opinions on diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018) formulated by Chinese Society of Gastroenterology, Chinese Medical Association The diagnosis of IBD was confirmed by clinical, laboratory, radiographic, digestive endoscopy and histopathological examination.	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; Other Names: DNA is extracted and genetic testing is performed
control group; During the same period, healthy subjects were collected from the physical examination center of our hospital as subjects of the normal control group. Infectious diarrhea, ischemic bowel disease, radiation enteritis, gastrointestinal tumor, diabetes, systemic lupus erythematosus, rheumatoid arthritis and autoimmune thyroiditis were excluded from all clinical examinations before inclusion.	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; Other Names: DNA is extracted and genetic testing is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Study Director: Ting Li, PHD, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: IBD;gene;Chinese Han population
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Disease Susceptibility; Inflammatory Bowel Diseases; Intestinal Diseases; Genetic Predisposition to Disease
• Other Study ID Numbers: SAHoWMU-CR2021-01-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No