Breath-based test using an oral probe to detect liver cirrhosis

A Case Control Study in a Population With Clinical Suspicion of Liver Cirrhosis to Develop a Risk Model for the Presence of Cirrhosis Using Breath Biomarkers/EVOC Probes

This will try a breath test where you drink a safe probe and we see if the breath chemicals can detect cirrhosis in adults with signs or risk factors for liver disease.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Owlstone Ltd (Industry-sponsored)
• Locations: 4 sites (Chandler, Arizona and 3 other locations)
• Trial ID: NCT07035158 on ClinicalTrials.gov

What this trial studies

The study gives an oral probe (Libra Oral Solution) that is metabolized in the liver and produces volatile compounds measurable in exhaled breath. Participants are adults with clinical suspicion of cirrhosis and will be grouped as definitive, probable, possible, or absent cirrhosis using routine clinical data. Breath samples after probe ingestion will be compared across groups in a case-control design with recruitment enrichment to ensure balanced representation. The goal is to identify breath signatures that differentiate cirrhosis from non-cirrhosis in a real-world clinical population.

Who should consider this trial

Good fit: Adults aged 18 or older who can give informed consent and have a clinician-documented suspicion of cirrhosis within the past six months are eligible.

Not a fit: People without clinical suspicion of liver disease or those who received recent disease-modifying interventions for liver disease are unlikely to benefit from this test.

Why it matters

Potential benefit: If successful, this could provide a simple, non-invasive way to detect cirrhosis earlier so patients can get treatment and monitoring sooner.

How similar studies have performed: Early work, including prior data from Owlstone, showed promising accuracy versus healthy controls, but breath-probe approaches for cirrhosis remain novel and need validation in clinically suspected populations.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years.
2. Able to provide written informed consent.
3. Clinical suspicion of cirrhosis evaluated in the last six months preceding the recruitment into the study.

The presence of clinical suspicion is at the discretion of the (referring) clinician. For reference this will typically be based on (a combination of) the following:

* Risk factors: viral hepatitis, metabolic dysfunction associated steatotic liver disease (MASLD), alcoholic liver disease, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, haemochromatosis or combinations of these diseases
* Symptoms: e.g. fatigue, weakness, abdominal pain, nausea, vomiting, loss of appetite, oedema, jaundice, spider angioma, palmar erythema, clubbing, gastrointestinal bleeding or altered blood parameters in a liver function test.

Exclusion Criteria:

1. Interventional treatment for (underlying cause of) cirrhosis aimed at disease modification during the past six months. Any treatment solely focused on symptom/complications management are permissible.
2. Received an investigational medicinal product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe.
3. Women who are pregnant or breastfeeding, for women of childbearing potential a urine pregnancy test can be administered
4. Known allergy/intolerance to any of the constituents of the EVOC-probe cocktail, specifically limonene, 2-butanol, 2-pentanone, polysorbate 80 (aka Tween-80), and sucralose.
5. Subjects on peritoneal- or hemo-dialysis
6. Primary referral for evaluation of the presence of liver cancer (e.g. abnormal findings on imaging).
7. The presence of histopathologically diagnosed liver cancer.
8. (Anticipated) inability to complete the breath sampling procedure due to e.g., inability to maintain adequate ventilation unaided / Inability to comply with the study procedures in the opinion of the investigator.

Where this trial is running

Chandler, Arizona and 3 other locations

• Arizona Liver Health — Chandler, Arizona, United States (Recruiting)
• Hospital Padre Hurtrado — Santiago, Chile (Recruiting)
• Norfolk and Norwich Hospital — Norwich, United Kingdom (Recruiting)
• Peterborough City Hospital — Peterborough, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Arun Shankar — Norfolk & Norwich University Hospital
• Study coordinator: Chloe Ms Bartlett

Conditions Cirrhosis, Liver