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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-26

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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IBD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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High fucosylation group

Immunohistochemistry was used to detect the fucosylation level in the intestinal tissue biopsy of patients with Crohn's disease at baseline. The fucosylation level in the baseline intestinal tissue was higher than 50% of the total.

No interventions assigned to this group

Low fucosylation group

Immunohistochemistry was used to detect the fucosylation level in the intestinal tissue biopsies of patients with Crohn's disease at baseline. The fucosylation level in the baseline intestinal tissue was less than 50% of the total.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes