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

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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Key information

Conditions

IBD Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

clinical remission rate at 24 week

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jan 12, 2024
Registry last updated: Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed