The Associations of Microribonucleic Acid Gene Polymorphisms With the Risk of Ulcerative Colitis

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Biological: vedolizumab

• Registration Number: NCT06873711
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

From January 2020 to December 2024, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our aim is to investigate the associations of microribonucleic acid(miRNA) gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of miRNAs gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.

Detailed Description

From January 2020 to December 2024, diagnosed UC patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of miRNAs were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of miRNAs gene polymorphisms between UC group and normal control group, as well as the effects of miRNAs gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of UC patients.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-02
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 926

Inclusion Criteria

• diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria

• rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC patients	vedolizumab	Some UC patients received intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.

Primary Outcome Measures

Name	Time	Method
Genotypes of miRNAs	Baseline	multiplex polymerase chain reaction-ligase detection reaction technique

Trial Locations

Locations (1)

the Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China