Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Strathclyde | OTHER |
| University of Amsterdam | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Healthy volunteer: self-declared healthy individual (no known illness or medications) with Normal BMI |
| |
| Nonalcoholic steatohepatitis | NAFLD without cirrhosis: Metabolic syndrome with known liver disease (NAFLD, excluding other coexisting liver condition) without cirrhosis |
| |
| NAFLD Cirrhosis | NAFLD cirrhosis: well characterised NAFLD compensated cirrhosis (Child's A-B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath analysis - electronic signature "Breath-print" | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterise the electronic signature "breath-print" in pre-defined cohorts | Identify disease specific electronic nose wave pattern | 12 months |
| Characterisation of exhaled breath composition | Molecular characterisation of breath volatile organic compounds through Gas Chromatography and Mass Spectrometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Profiling intestinal microbiome and assessing end-metabolic products in urine | Demonstrate dysbiosis in stool microbial and characterise metabolic products in urine of cohorts studied | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter C Hayes, MD,PhD,FRCPE | Centre for liver and digestive disorder, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility - Wellcome Trust, Royal Infirmary Site | Edinburgh | Midlothian | EH16 4SA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24135544 | Result | Wlodzimirow KA, Abu-Hanna A, Schultz MJ, Maas MA, Bos LD, Sterk PJ, Knobel HH, Soers RJ, Chamuleau RA. Exhaled breath analysis with electronic nose technology for detection of acute liver failure in rats. Biosens Bioelectron. 2014 Mar 15;53:129-34. doi: 10.1016/j.bios.2013.09.047. Epub 2013 Sep 30. | |
| 26469298 | Result |
Not provided
Not provided
Individual participant data will not shared. Participants will be identified as a part of pre-defined cohort as categorised clinically.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Stool, urine and blood sample for predetermined Non-DNA analysis. Intestinal microbial identification with 16s RNA sequencing
|
| de Vries R, Brinkman P, van der Schee MP, Fens N, Dijkers E, Bootsma SK, de Jongh FH, Sterk PJ. Integration of electronic nose technology with spirometry: validation of a new approach for exhaled breath analysis. J Breath Res. 2015 Oct 15;9(4):046001. doi: 10.1088/1752-7155/9/4/046001. |
| 19795029 | Result | Probert CS, Ahmed I, Khalid T, Johnson E, Smith S, Ratcliffe N. Volatile organic compounds as diagnostic biomarkers in gastrointestinal and liver diseases. J Gastrointestin Liver Dis. 2009 Sep;18(3):337-43. |
| 20673359 | Result | Wu GD, Lewis JD, Hoffmann C, Chen YY, Knight R, Bittinger K, Hwang J, Chen J, Berkowsky R, Nessel L, Li H, Bushman FD. Sampling and pyrosequencing methods for characterizing bacterial communities in the human gut using 16S sequence tags. BMC Microbiol. 2010 Jul 30;10:206. doi: 10.1186/1471-2180-10-206. |
| 40391721 | Derived | Sinha R, Gillespie SL, Brinkman P, Bassett P, Lockman KA, Jaap AJ, Fallowfield JA, Hayes PC, Plevris JN. Volatomics for Diagnosis and Risk Stratification of MASLD: A Proof-Of-Concept Study. Aliment Pharmacol Ther. 2025 Jul;62(2):180-192. doi: 10.1111/apt.70176. Epub 2025 May 20. |
| 32775974 | Derived | Sinha R, Lockman KA, Homer NZM, Bower E, Brinkman P, Knobel HH, Fallowfield JA, Jaap AJ, Hayes PC, Plevris JN. Volatomic analysis identifies compounds that can stratify non-alcoholic fatty liver disease. JHEP Rep. 2020 Jun 15;2(5):100137. doi: 10.1016/j.jhepr.2020.100137. eCollection 2020 Oct. |