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

Completed
Conditions
IBD
Registration Number
NCT06203158
Lead Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
clinical remission rate at 24 weekat 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Second Affiliated Hospital of Wenzhou Medical University

🇨🇳

Wenzhou, Zhejiang, China

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