Early Liver Disease Breath Detection

NCT05935488 | Unknown

• 1 other identifier: OML-004
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Fibrosis; NASH; Liver Diseases

Outcome Measures

Primary Outcomes (1)

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

  To determine this the breath profiles of subjects with liver fibrosis will be compared to the breath profiles from a previously measured healthy cohort.

  Through study completion, an average of 4 months

Secondary Outcomes (2)

• To demonstrate intra-subject variability in NASH patients is comparable to that in healthy volunteers observed previously.

  Through study completion, an average of 4 months

• To demonstrate that there are correlations between abundance of EVOCs and/or their metabolites on breath and fibrosis stage and scoring determined by blood metrics or imaging modalities previously collected.

  Through study completion, an average of 4 months

Study Arms (1)

Early Liver Disease

A total of 30 subjects with fibroscan confirmed liver fibrosis likely due to non-alcoholic steatohepatitis (NASH) will be recruited.

Other: EVOCs emulsion

Interventions

EVOCs emulsion OTHER

Continuous breath sampling directly into SIFT-MS equipment. The instrument is equipped with a mouthpiece connected to the SIFT inlet where the subject blows in and the breath is analyzed in real-time

Also known as: Selected-ion flow-tube mass spectrometry (SIFT-MS)

Early Liver Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 30 subjects with fibroscan confirmed liver fibrosis likely due to NASH will be recruited. To be eligible for the study participation, subjects must meet the inclusion and exclusion criteria.

You may qualify if:

• 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)

You may not qualify if:

• (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.

Sponsors & Collaborators

• Owlstone Ltd: lead
• North Norfolk Primary Care Practices: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator

Study Sites (1)

North Norfolk Primary Care

Norwich, Norfolk, NR11RB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chloe Fitzpatrick

CONTACT

01223428200; NNN@owlstone.co.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: May 21, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 22, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)