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A Study on the Associations Between Microribonucleic Acid Gene Polymorphisms and Crohn's Disease

A Study on the Associations Between Microribonucleic Acid Gene Polymorphisms and Crohn's Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06935929
Enrollment
839
Registered
2025-04-20
Start date
2020-01-01
Completion date
2025-01-01
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Brief summary

From January 2020 to January 2025, Crohn's disease (CD) patients and gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. The aim of this research is to explore the associations of microribonucleic acids (miRNAs) gene polymorphisms with the risk and clinicopathological characteristics of CD, and to analyze the effects of miRNAs gene variantions on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Detailed description

From January 2020 to January 2025, a total of 312 CD patients and 527 gender- and age-matched normal controls were collected from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University.The genotypes of miRNAs were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression was employed to analyze the distribution of miRNAs gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics of CD patients. Unconditional logistic regression model was used to explore the effect of miRNAs gene variation on the clinical response of CD patients in the treatment of UST at week 8.

Interventions

Some CD patients received sufficient UST (6 mg/kg) intravenous infusion at week 0, followed by one subcutaneous dose of 90 mg UST at week 8.Maintenance therapy consisted of 90 mg subcutaneous UST every 8 or 12 weeks.

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* diagnosed CD 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.

Design outcomes

Primary

MeasureTime frameDescription
the genotypes of miRNAsBaselinemultiplex polymerase chain reaction-ligase detection reaction technique

Secondary

MeasureTime frameDescription
clinical response of ustekinumab treatmentweek 8the changes of Harvey-Bradshaw index (HBI)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026