CompletedNot Applicable

Early Liver Disease Breath Detection

United Kingdom1 participantsStarted 2024-05-21

Plain-language summary

The Early Liver Disease Breath Detection Study is a cross-sectional study where subjects with advanced liver fibrosis will ingest a mixture of food-grade compounds (known as Exogenous Volatile Organic Compound or EVOCs) in the form of an emulsion and then provide multiple breath samples. These EVOCs can be measured on exhaled breath and it has been found that liver diseases can affect the way EVOCs are processed in the body. The objective is to identify if changes in the way these EVOCs are processed in the body can have the potential to diagnose early stage liver diseases for these subjects. Subjects with fibro-scan confirmed fibrosis will be recruited from Norfolk and Norwich University Hospital (NNUH) by local research staff, they will be invited to take part in the study at a dedicated clinic at OneNorwich Practises a clinic based in Norwich City Centre. They will be asked to fast overnight then provide a baseline breath sample, before ingesting the food-grade EVOCs emulsion and then providing additional breath samples at subsequent time points up to 90 minutes post ingestion.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 compoun…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To demonstrate the potential of using breath profiles of administered flavoring compounds and their metabolites to assess liver fibrosis.

Timeframe: Through study completion, an average of 4 months

Trial details

NCT IDNCT05935488

SponsorOwlstone Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More Liver Fibrosis trials