Metabonomic and Microbiomic profile of Pruritus and Fatigue in PBC
Research type
Research Study
Full title
Metabonomic and Microbiomic profile of Pruritus and Fatigue in Primary Biliary Cirrhosis.
IRAS ID
153282
Contact name
David Jones
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Research summary
Primary Biliary Cirrhosis (PBC) is a condition that commonly affects young-middle aged people. It is more common in women. Many patients with PBC develop symptoms of fatigue and/or itch (pruritus) which can become severe and affect their quality of life. It is not entirely clear why PBC patients develop these symptoms. There are studies to suggest that bile acids present in the bile (produced in the liver) cause the itch. Normal bacteria present in the bowel may have a role in the development of PBC symptoms. Currently there are no treatments for PBC patients with fatigue. Few medications are available for PBC patients with itch. Those who do not respond to medications are generally offered to undergo an endoscopy to insert a tube in their bile tube and drain out bile. An ongoing clinical trial (GSK IBAT trial) is currently recruiting PBC patients with itch to trial a new treatment for itch.
In the proposed research study (MetaMic-PBC study) we aim to understand the mechanism of development of itch and fatigue in PBC. To do this, we need participants to donate samples of their blood, urine and stool (faeces). These participants will be healthy volunteers with no PBC, PBC patients with no symptoms and PBC patients with fatigue but no itch. The participants will be matched to the participants in the GSK IBAT drug trial with respect to age, sex, ethnicity and geographical location (post code). Samples obtained from study participants will serve as comparator to the samples obtained from the PBC patients with itch recruited in the GSK-IBAT trial. In addition, patients with severe itch due to PBC who have agreed to undergo an endoscopy procedure to drain their bile will be invited to participate in this study. These patients will provide samples of their blood, urine, stool and bile. These samples will be studied and analysed for chemicals that may be unique to itch and fatigue in PBC. The stool samples will be studied for the bacteria.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1036
Date of REC Opinion
21 Jul 2014
REC opinion
Further Information Favourable Opinion