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临床试验/NCT06149949
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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 100 人开始时间: 2024年1月1日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

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