Breath Analysis Using an Electronic Nose in Non Alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Breath analysis - electronic signature "Breath-print"
Intervention type(s): Device
Intervention description(s): Patients and Healthy volunteers ( as defined in 3 cohorts) will breath into disposable, once-use only bacterial filter channeled into electronic device comprising on sensors capable to reacting to organic compounds. Breathing manoeuvre will be simple, non-exertional and relaxed. 2 breathing manoeuvres will be performed and sensor responses will be captured.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All eligible patients will have to consent to the study. The study population will consist
        of participants aged between 18 and 75 years old in the following cohorts (Healthy
        individuals, Non-alcoholic steatohepatitis (non-cirrhotic) and compensated Non-alcoholic
        liver cirrhosis). Each cohort will have 30 patients. There will be an equal number of
        participants for the healthy control group. In summary, the investigators aim to recruit 30
        subject in the patient cohorts and 30 in healthy, totaling a number of 90 in the study
      
Biospecimen description: 
      Stool, urine and blood sample for predetermined Non-DNA analysis. Intestinal microbial
      identification with 16s RNA sequencing
    
Keywords: Electronic nose; Non invasive diagnosis of NAFLD; NAFLD; exhaled breath analysis; Volatile organic compounds