NCT06873711

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 926 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
BIOLOGICAL	vedolizumab	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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study