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临床试验/NCT02641171
NCT02641171终止不适用

Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Metabolic profile: metabolite concentrations in blood

研究概览

简要总结

This study evaluates the use of exhaled air analysis as tool to monitor the disease activity in Crohn's Disease (CD). This study is a validation of the previous findings. In this study the participant will be asked to donate exhaled air, blood samples and fecal samples. The breath samples will be used to measure various volatile metabolites in breath. The breath air will be next used to validate the previous findings. The blood samples will be used to define the origin of volatile metabolites in breath. Finally, the potential of exhaled breath analysis as non-invasive marker of diseases activity will be compared to established fecal calprotectin.

详细描述

In the recent study(doi: 10.1097/Mib.0000000000000436) it was shown the potential of analysis of exhaled air to differentiate active and inactive state of Crohn's Disease (CD). Although, the molecules found in this cohort have shown potential to differentiate between CD patients in remission or with active disease, the validation of the outcomes has to be performed in new population. One crucial pathophysiologic factor in CD is excessive lipid peroxidation during oxidative stress, i.e. during overproduction of oxidants compared to the protective antioxidants. Oxidative stress is a potential aetiological factor and/or a triggering factor in CD. Many volatile compounds including hydrocarbons and aldehydes are produced during oxidative stress and they can be non-invasively measured in exhaled air 5, 6. However, exhaled breath contains volatile metabolites originating from previous or current uptake of environmental contaminants, and more interestingly from metabolism of foreign organisms (bacteria, viruses, fungi or yeasts). Therefore, it is important to study not only exhaled air but also blood in which blood borne volatile molecules can be measured. Since the current study also aims for validating the use of volatile molecules in exhaled air as non-invasive markers for disease activity in CD patients, the investigators will compare the outcome of exhaled air analysis with currently established non-invasive measure of disease activity, i.e. fecal calprotectin.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-65
  • BMI: 19-30
  • scheduled colonoscopy

排除标准

  • disease compromising immune system (such as HIV positive status or patients after organ transplantation
  • liver disease
  • active and untreated tuberculosis
  • chemotherapy agents

结局指标

主要结局

Metabolic profile: metabolite concentrations in blood

时间窗: The samples will be collected within no more than one week before scheduled colonoscopy.

Blood samples will be used to better understand the origin of the volatile compounds in breath.

Fecal calprotectin (µg/g) in fecal samples

时间窗: The samples will be collected within no more than one week before scheduled colonoscopy.

Fecal calprotectin will be measured as indicator of the migration of neutrophils to the intestinal mucosa.

Volatile organic compounds profile: volatile compound concentrations in breath

时间窗: The samples will be collected within no more than one week before scheduled colonoscopy.

The exhaled air samples will be used to first validate the volatile compounds for disease activity in Crohn's Disease.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agnieszka Smolinska

Postdoc

Maastricht University

研究点 (1)

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