NCT06149949尚未招募不适用
Ambispective Pilot Study on the Prevalence of Chronic Rhinosinusitis Associated With Inflammatory Bowel Disease and Association With Biomarkers of Epithelial Barrier Damage
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
研究概览
简要总结
The goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease.
The main questions it aims to answer are:
- Evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease
- Evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -Evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease
- Evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice
- Presence of enterotoxin sensitization to S. Aureus in patients with intestinal bowel disease
- Histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only.
Patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at CEMAD will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 years and 70 years.
- •Diagnosis of Crohn's disease or Ulcerative Rectocolitis
- •Willingness to participate in the study and ability to comply with and understand the study protocol.
- •Patients with a previous diagnosis of Crohn's disease or Ulcerative Rectocolitis for at least 3 months prior to screening
- •Signature of informed consent
排除标准
- •Age <18 years
- •Refusal of informed consent
结局指标
主要结局
prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
时间窗: 1 hour
To define the prevalence of chronic rhinosinusitis in patients with chronic inflammatory bowel disease
次要结局
未报告次要终点
研究者
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