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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06203158
Enrollment
50
Registered
2024-01-12
Start date
2023-12-26
Completion date
2024-02-28
Last updated
2024-03-08

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

Conditions

IBD

Keywords

durg efficacy, Crohn's Disease, Ustekinumab, Intestinal Epithelial Fucosylation

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
clinical remission rate at 24 weekat 24 weekA 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.

Countries

China

Outcome results

None listed

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