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临床试验/NCT04418622
NCT04418622已完成不适用

Evolution of the Endonasal Microbiota After Endoscopic and Local Treatment or Local Treatment Alone in Patients With Chronic Rhinosinusitis

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
description of biodiversity of the microbiota

研究概览

简要总结

Chronic rhinosinusitis (CRS) is defined according to the French society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. The duration of the chronic impairment must be at least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and anosmia. It is a poorly understood pathology that affects a large part of the population. Its prevalence has increased significantly over the past 30 years. It affects about 11% of the population in Europe. It has become one of ten high-cost medical conditions for employers. Initially, it was accepted that CRS was due to chronic nasal infection. It is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential.

Today, it is recognized that CRS has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes group. .

Few studies have studied the modification of the microbiota with the treatment of CRS today. However, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from CRS. This study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • patients without chronic rhinosinusitis who undergo a nasal surgery
  • patients with chronic rhinosinusitis who undergo a medical or surgical treatment

排除标准

  • minor patients
  • pregnant or lactating women
  • patients undergoing antibiotic therapy in the month preceding the start of the study
  • patients with immunosuppression
  • ENT cancer or other cancer in progress
  • primary ciliary dyskinesia or cystic fibrosis
  • Systemic vasculitis (Wegener, Gougerot-Sjögren ...)
  • Refusal to participate in the study

结局指标

主要结局

description of biodiversity of the microbiota

时间窗: six month

Shannon index

richness of samples

时间窗: six month

number of OTU (operational taxonomic unit)

次要结局

  • rhinosinusal inflammation(six month)
  • patient quality of life(six month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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