NCT06203158已完成不适用
Intestinal Epithelial Fucosylation Affects the Efficacy of Ustekinumab in Crohn's Disease
Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- clinical remission rate at 24 week
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with moderate to severe Crohn's disease
- •Receiving treatment with ustekinumab
- •Received colonoscopy and collected intestinal tissue samples before and after treatment
排除标准
- •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
结局指标
主要结局
clinical remission rate at 24 week
时间窗: 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.
次要结局
未报告次要终点
研究者
研究点 (1)
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