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临床试验/NCT02950610
NCT02950610已完成不适用

Breath Analysis Using an Electronic Nose in Non Alcoholic Fatty Liver Disease (BEN) Study

University of Edinburgh1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Characterisation of exhaled breath composition

研究概览

简要总结

The purpose of this is to analyse human exhaled breath by means of a device called electronic nose(eNose) in patients with non-alcoholic fatty liver disease (NAFLD) as a way to non-invasive assessment of liver disease.This device is medically adapted and clinically validated in patients with lung conditions.

详细描述

Human exhaled breath contains over 3000 volatile organic compounds (VOCs) that vary in relative concentration in health and disease. Metabolic disorders affecting the liver, such as NAFLD, produce disproportionate organic compounds produced as a by-product of metabolism and thus expired in exhaled breath, excreted in urine and detectable in blood. NAFLD prevalence is increasing and has reached epidemic proportions affecting 90% of obese adults and 22%-53% of obese children.Liver biopsy is the gold standard in diagnosing NAFLD, but it is unpleasant and can lead to complications. There is an unmet need to develop a non-invasive method of assessing liver disease. Comon Invent (Delft, Netherlands) together with the respiratory department at the Amsterdam Medical Centre (AMC), University of Amsterdam, have adapted the electronic nose known as SpiroNose as a prototype device for clinical use. Sensitive electronic sensors detect molecules in breath and generate signals. Complex algorithms and analytical technics allow pattern recognition of breath samples from different subjects. Well charaterised patients will be selected into clinical categories of non-alcoholic fatty liver disease with and without cirrhosis and be compared with healthy individuals.

Edinburgh will be the only site conducting this study. In addition to exhaled breath analysis, blood and urine will be collected to study the end products of metabolism.Furthermore, stool and urine collected from some subjects will be analysed to understand the role of gut bacteria in fermentation, metabolic products as a result cause VOC production.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals with no known or self declared medical illness with BMI (body mass index) within normal range (18.5-25)
  • Non alcoholic fatty liver disease without cirrhosis
  • Compensated (no evidence of ascites, encephalopathy) NAFLD cirrhosis; assessed by scoring system - Child's Pugh

排除标准

  • Ongoing or recent (within last 6months) alcohol consumption more than 21 units per week for males and 14 units per week for females.
  • BMI > 40
  • Chronic respiratory disease e.g. Chronic obstructive pulmonary disease (COPD), asthma, interstitial fibrosis
  • Use of antibiotics within last 4 weeks of sample collection and inflammatory bowel disease, irritable bowel syndrome, celiac sprue, or other chronic inflammatory diseases of the intestines (for intestinal microbiome analysis)
  • Other known liver disease e.g. Primary Biliary Cholangitis/cirrhosis (PBC), Alcoholic liver disease (ALD), Autoimmune and hepatitis
  • Inability to provide informed consent.
  • Participation in other clinical intervention/drug trial

结局指标

主要结局

Characterisation of exhaled breath composition

时间窗: 12 months

Molecular characterisation of breath volatile organic compounds through Gas Chromatography and Mass Spectrometry

Characterise the electronic signature "breath-print" in pre-defined cohorts

时间窗: 12 months

Identify disease specific electronic nose wave pattern

次要结局

  • Profiling intestinal microbiome and assessing end-metabolic products in urine(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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