Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
Breath Analysis Using an Electronic Nose in Non Alcoholic Fatty Liver Disease (BEN) Study
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.
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.
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