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

S

Second Affiliated Hospital of Wenzhou Medical University

Status

Completed

Conditions

IBD

Study type

Observational

Funder types

Other

Identifiers

NCT06203158
SAHoWMU-CR2023-01-112

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

High fucosylation group
Description:
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.
Low fucosylation group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Yi Jiang, Doctor

Data sourced from clinicaltrials.gov

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