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

NCT06203158 | Completed

• 1 other identifier: SAHoWMU-CR2023-01-112
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).

You may qualify if:

• Diagnosed with moderate to severe Crohn's disease
• Receiving treatment with ustekinumab
• Received colonoscopy and collected intestinal tissue samples before and after treatment

You may not qualify if:

• Pregnancy
• Hypersensitivity to any component of ustekinumab
• Cognitive or developmental disabilities prevent you from completing this study
• Combined with diseases such as RA, diabetes, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis and tumors

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 12, 2024
• Study Start: December 26, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 28, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)