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临床试验/NCT03321708
NCT03321708Unknown不适用

Respiratory Microbiome in COPD. Relationship With Systemic and Pulmonary Inmune Response.

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Relationship of pulmonary microbiome with the immune response (local and systemic).

研究概览

简要总结

Hypothesis:

COPD patients with frequent exacerbations have different pulmonary and systemic immune response than COPD patients without frequent exacerbations and this is related to their microbiome.

详细描述

The objective of this project is to determine the pulmonary microbiome and its relationship with the pulmonary and systemic inmune response in COPD patients with frequent (FE) and non frequent exacerbations (NE).

  1. The pulmonary immune response.

-The role of mucins, antimicrobial peptides (AMPs), Matrix metalloproteinases (MMPs) and Toll-like receptors (TLRs) as lung defense mechanisms and their possible relationship with the microbiome in COPD and FE patients. 2. The systemic immune response. -The pulmonary and blood inflammatory response and circulating bacterial products as markers of the systemic immune response.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of COPD according to national and international guidelines.
  • Clinical stability (8 previous weeks).
  • Signature of informed consent.

排除标准

  • Antibiotic treatment the previous 8 weeks.
  • Other lung diseases.
  • Active neoplasic disease.
  • Terminal concomitant disease.

结局指标

主要结局

Relationship of pulmonary microbiome with the immune response (local and systemic).

时间窗: 6 months

Microbiome will be determined by using 16s RNA techniques. The inmune response will be studied with ELISA kits.

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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