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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof David Jones
david.jones@ncl.ac.uk


Dr Jessica Dyson
jessicadyson@doctors.org.uk


Study Location:

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Be Part of Research - Trial Details - Metabonome & Microbiome Variability & Differential Risk in PBC

Metabonome & Microbiome Variability & Differential Risk in PBC

Completed

Open to: Female / Male

Age: 18 Years - N/A

Medical Conditions

Diseases of liver


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Primary Biliary Cirrhosis (PBC) is a rare, autoimmune liver disease which arises due to a combination of genetic and environmental factors. PBC is a highly gender-skewed disease, with approximately 90% of affected patients being female. In the UK, 7% of all adult elective liver transplants were performed for PBC in 2013/14. Risk is particularly high in younger patients. Although therapy exists in the form of Ursodeoxycholic acid (UDCA), its effectiveness is limited and it contributes least in the highest risk patients. At present, treatment in PBC is entirely focused on damage control rather than treating underpinning processes.

Three groups are at particularly increased risk of PBC and may represent an important setting in which to explore environmental triggers and ways to alter disease course. These groups are: 1) Individuals with the characteristic PBC antibody (anti-mitochondrial antibody, AMA) but who do not have liver injury (normal liver blood tests) 2) The daughters of mothers with PBC who have a 30-fold increased risk of PBC 3) Patients who have undergone liver transplantation for PBC and have a 1 in 3 chance of developing recurrent PBC within 5 years.

PBC is characterised by changes in bile acids which lead to damage to liver cells and bile ducts. Bile acids are exposed to bacteria (bugs) in the gut (the microbiome). Bacteria in the gut are significantly different in females and males which is potentially important in a highly female-predominant disease such as PBC.

There will be four linked studies using state of the art technologies to explore differences in bile acids and gut bacteria between people with PBC, those ‘at risk’ of PBC, patients with primary sclerosing cholangitis (another liver disease) and healthy controls. If the theory is correct then we could potentially change the gut bacteria to reduce the risk of developing disease.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 Mar 2016 05 Apr 2018

Observational

Observational type: Case-controlled study;



You can take part if:



You may not be able to take part if:


-Age < 18 - Unable or unwilling to give informed consent - Diagnosis of another form of liver disease e.g. NAFLD, alcohol related liver disease


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Dr Jessica Dyson
jessicadyson@doctors.org.uk


Prof David Jones
david.jones@ncl.ac.uk



The study is sponsored by THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST and funded by LIVERNORTH .




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for Trial ID: CPMS 31421

Last updated 21 October 2022

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