Breath analysis using Electronic nose in NAFLD (BEN) Study
Research type
Research Study
Full title
Breath analysis using an Electronic nose for Non alcoholic fatty liver disease (BEN) study
IRAS ID
165914
Contact name
John Plevris
Contact email
Clinicaltrials.gov Identifier
Wellcome Trust Clinical Research Facility, E151593
Duration of Study in the UK
1 years, 4 months, 14 days
Research summary
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.
A compact electronic device known as SpiroNose (electronic nose) is medically adapted and clinically validated in patients with lung conditions. We aim to analyse breath with the electronic nose in patients with non-alcoholic fatty liver disease (NAFLD) as a feasibility study of non-invasive assessment of liver disease.
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) 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 technicals allow pattern recognition of breath samples from different subjects. Data generated from the electronic nose will not be used in the pursuit of a CE mark. 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.
The Royal Infirmary of Edinburgh will be the only site conducting this study lasting 18 months. In addition to exhaled breath analysis, blood and urine will be collected to study the end products of metabolism.Furthermore, stool collected from some subjects will be analysed to understand the role of gut bacteria in fermentation and VOC production.REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0207
Date of REC Opinion
7 Jan 2016
REC opinion
Further Information Favourable Opinion