Detecting early liver disease through breath analysis

Breath Detection of Non-alcoholic Steatohepatitis (NASH)-Induced Metabolic Alterations Using Food Flavors.

This study is testing whether analyzing breath samples can help detect early liver diseases in people with advanced liver fibrosis.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Owlstone Ltd (Industry-sponsored)
• Locations: 1 site (Norwich, Norfolk)
• Trial ID: NCT05935488 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify early-stage liver diseases by analyzing breath samples from subjects with advanced liver fibrosis. Participants will ingest a mixture of food-grade compounds known as Exogenous Volatile Organic Compounds (EVOCs) and provide breath samples at various time points. The study focuses on how liver diseases affect the processing of these compounds, potentially offering a non-invasive diagnostic tool for conditions like non-alcoholic steatohepatitis (NASH). The research will be conducted at the Norfolk and Norwich University Hospital, where subjects will be recruited and monitored.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with confirmed advanced liver fibrosis and a diagnosis of non-alcoholic steatohepatitis (NASH).

Not a fit: Patients with cirrhosis or current hepatocellular carcinoma (HCC) will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive method for diagnosing early liver diseases, reducing the need for invasive procedures like liver biopsies.

How similar studies have performed: While the use of breath analysis for liver disease detection is a novel approach, previous studies have shown promise in using volatile organic compounds for diagnosing other conditions.

Eligibility criteria

Inclusion Criteria:

* Able to provide written informed consent.
* \>18 years old.
* Body weight \> 50 kg.
* Alcohol consumption - does not drink to excess (\>30 g/day in men, \>20 g/day in women).
* Fibroscan kilopascal (kPa) between 8.5 and 13.5 within 6 months and/or a liver biopsy within the last 3 years showing a fibrosis activity score ≥ F2 and a NAS score \> 4 with a diagnosis of non alcoholic steatohepatitis (NASH)

Exclusion Criteria:

* (Anticipated) inability to complete the breath sampling procedure due to e.g. inability to maintain adequate ventilation unaided or claustrophobia / Inability to comply with the study procedures in the opinion of the investigator.
* Participant has cirrhosis.
* Participant has current hepatocellular carcinoma (HCC) or currently being treated for HCC. Those previously with/treated for and now clear of HCC can be recruited.
* Participant's cause of liver disease is known to be one of alcohol abuse, hepatitis, autoimmune hepatitis, medications, haemochromatosis, alpha1 antitrypsin deficiency, Wilson disease, biliary problems.
* Presence of current common cold or any other infectious disease including any recent symptoms of Covid-19.
* Participant is known to be pregnant or breast feeding.
* Participant with a diagnosis of chronic, active gastritis
* Participant is affected by asthma, chronic obstructive pulmonary disease (COPD), and/or airway hyperactivity.
* Known intolerances and/or allergies (\*) to any food containing tested compounds. For limonene, citrus fruits, and fruit juices. For benzyl alcohol, apricots, cranberries, and cocoa. For 2-pentanone cheddar cheese, ripe bananas, and defatted soybean flour. For 2-butanol cheddar cheese and yogurt. For nonanal, apple, avocado, black currants, cooked beef, cucumber, fish, grapefruit, lemon, lime, mandarin, orange, and peach.

Where this trial is running

Norwich, Norfolk

• North Norfolk Primary Care — Norwich, Norfolk, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Chloe Fitzpatrick

Conditions Liver Fibrosis; NASH; Liver Diseases