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临床试验/NCT06822725
NCT06822725进行中(未招募)不适用

The Sinonasal Microbiome

University of Chicago1 个研究点 分布在 1 个国家目标入组 285 人开始时间: 2025年1月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
285
试验地点
1
主要终点
Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service

研究概览

简要总结

Chronic rhinosinusitis is an inflammatory disease of the sinonasal mucosa with significant impact and limited treatment options. Chronic rhinosinusitis (CRS) poses an important public health problem and causes a large impact on individual quality of life. Studies of CRS have been limited by access to tissue, the complexity of the sinonasal physiology, a lack of available biomarkers, the absence of useful animal models, a paucity of cohorts with biological samples for analysis, and limited well-designed clinical trials or investigations of immune function. Therefore, novel strategies for identifying biological mechanisms underlying this disease are in great need.

Using prospective samples from well characterized subjects, the investigators intend to profile the mucosa associated-bacteria in the nose and sinuses. In parallel, using sinus tissue from patients undergoing surgery, the site will interrogate the epithelium for mucosal immune function to understand host-microbe interaction. This study hypothesizes that the microbial profile of the sinuses initiates an immune responses which leads to chronic inflammation in susceptible people. This study would provide the first comprehensive data on what bacteria are present in the nose and sinus and could lead to important knowledge useful in sinonasal disease.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years
  • Diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy

排除标准

  • Use of immunosuppressants
  • Immunodeficiency
  • Inability to stop sinusitis related medications for 10 days

研究组 & 干预措施

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Those with and without nasal polyps, and those with acute exacerbations

干预措施: Chronic rhinosinusitis (CRS) with and without Nasal Polyposis (Procedure)

Control Group

Normals without allergy, those with perennial allergic rhinitis

干预措施: Control Group (Other)

结局指标

主要结局

Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service

时间窗: At baseline until final values at 36 months.

Determining the distinct bacterial profiles with shift toward anaerobic bacteria using the Pyrosequencing Pipeline service

时间窗: At baseline until final values at 36 months.

Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service

时间窗: At baseline until final values at 36 months.

次要结局

  • the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service(At baseline until final values at 36 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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