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NCT06203158 Clinical Trial

Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease

IBD Clinical Trial

Official title:
Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06203158
Other study ID # SAHoWMU-CR2023-01-112
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 26, 2023
Est. completion date February 28, 2024

Study information
Verified date March 2024
Source Second Affiliated Hospital of Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Molecular markers that can accurately predict the efficacy of UST are urgently needed to provide theoretical basis for guiding individualized treatment. Therefore, this study intends to explore the impact of intestinal epithelial fucosylation levels on the efficacy of UST in patients with Crohn's disease(CD), aiming to provide predictable molecular markers for UST to accurately treat CD.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 28, 2024
Est. primary completion date February 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Diagnosed with moderate to severe Crohn's disease 2. Receiving treatment with ustekinumab 3. Received colonoscopy and collected intestinal tissue samples before and after treatment Exclusion Criteria: 1. Pregnancy 2. Hypersensitivity to any component of ustekinumab 3. Cognitive or developmental disabilities prevent you from completing this study 4. Combined with diseases such as RA, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors

Study Design

Related Conditions & MeSH terms

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 clinical remission rate at 24 week A specialist will evaluate the HBI score at 24 week based on the patient's clinical symptoms and determine whether the patient is in clinical remission based on the score. at 24 week
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