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临床试验/NCT03451994
NCT03451994已完成不适用

Retrospective Analysis of Volatile Organic Compounds in Alveolar Breath as Biomarkers of Idiopathic Malodor

Mebo Research, Inc.2 个研究点 分布在 2 个国家目标入组 23 人开始时间: 2011年10月1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
23
试验地点
2
主要终点
VOCs detected

研究概览

简要总结

The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

详细描述

Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.

研究设计

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

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

  • good general health
  • willing and able to travel to one of the participating sites

排除标准

  • medical conditions that, in the opinion of the investigator, would prevent participation
  • elect not to participate in the study

结局指标

主要结局

VOCs detected

时间窗: 2 years

Expired air sample drawn principally from alveolar breath is analyzed by gas chromatography-mass spectrometry. Chromatograms are searched against the NIST library. The response for each analyte is normalized by using internal standards containing 1-bromo-4-fluoro-benzene.

次要结局

  • Correlations between breath biomarkers and self-reported observations (questionnaires)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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