BAALI (V2)
Research type
Research Study
Full title
Defining the molecular signature of acute autoimmune hepatitis to inform biomarker discovery.
IRAS ID
360291
Contact name
Karl Bonello
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The body’s immune system may create an inflammatory response to its own liver and this is called autoimmune hepatitis (AIH). The diagnosis of this condition includes a combination of symptoms / background health, blood tests and liver tissue sampling. It is often difficult to distinguish AIH from other causes of acute liver injury (ALI). Persons with suspected AIH need medical therapy to inhibit the immune system, which is often lifelong.
We intend to improve our understanding and diagnosis of AIH by analysing samples of liver tissue from persons with the condition to try and find new molecules / markers that can distinguish it from other conditions.
We also wonder whether any of these molecules can be detected in the blood of persons with ALI and therefore attempt at developing a suitable blood test to help diagnose the condition.
Researchers have also analysed the chemicals exhaled in breath, which are called volatile organic compounds (VOCs). This type of technique is called breathomics and it has previously been applied in the context of fatty liver disease and has been shown to distinguish persons with a healthy liver from those having fatty liver disease (A5-1). We are therefore interested in studying whether the pattern of VOCs exhaled in patients with AIH is different from healthy persons, and from patients with other causes of ALI.
Improving our methods of diagnosing AIH means that we can improve our timely selection of persons requiring treatment for it.
Participants with an undifferentiated ALI will be recruited and asked for an extra blood sample taken at the time of routine phlebotomy, and to exhale into a breathing tube connected to an analyser for up to 10 seconds, for up to 5 times if tolerated. No liver biopsy is required for this aspect of the research.REC name
South East Scotland REC 02
REC reference
25/SS/0072
Date of REC Opinion
5 Dec 2025
REC opinion
Further Information Favourable Opinion