Liver Disease Itching Study
Understanding the natural history and impact of itching (pruritus) in patients with drug-induced liver injury (DILI).
The liver produces bile, which goes to and from the gut to help us digest food. If there is a problem with this, bile acid in circulation can increase and cause itching (also called pruritus).
In drug-induced liver injury (an unpredictable adverse hepatic reaction to a medication), bile production may be affected as the liver is damaged. Therefore, some patients with drug-induced liver injury may develop itching as a symptom.
We aim to investigate why some patients who experience liver injury caused unexpectedly by drugs/supplements suffer from itching symptoms, and how it affects their quality of life. We aim to find out if, there are certain rare genetic variations linked to this and what factors, affect the severity of itching.
This will be part of a student PhD project.
Information about taking part in our research study:
We are curently recruiting participants for this study at Queen's Medical Centre, Nottingham.
Please contact our research centre 0115 9707966 (ext 80605) or email nddcbru@nottingham.ac.uk for further information
Clinical Trials.gov ID: NCT06446609
Important things to know about participating in our study:
We are inviting participants over 18 years old who have symptoms that may possibly be caused by drug-induced liver injury, based on liver function test results and medical history. (This may be later found to have another cause), but you can still continue in the study unless further tests show that your liver function is below the required threshold for inclusion, in which case we will not require any further participation). We are inviting around 60 participants to take part.
What will I be asked to do?
If you decide to take part, a trained member of the local research team will approach you, either at your medical appointment or via a letter offering a research appointment. At the appointment, they will explain the research study and answer any questions you may have. The research will usually be incorporated into your medical visit, where clinical blood samples are already being taken, and will take around 20 minutes.
At the appointment, the researcher will:
- Ask for your written consent to participate in the research.
- Measure your height, weight and waist circumference.
- Ask you to verbally complete a health questionnaire (22 questions).
- Discuss and collect your health & medical history (including medications and symptoms).
- Confirm your consent to anonymised data being shared with collaborators in the USA.
- Ask for your consent to access your digital medical records to follow your recovery over 2 years.
- Ask for a contact phone number so we can follow up on your progress and repeat the health questionnaire.
- Ask if we can keep your details in our secure database to contact you about our future research where relevant (optional).
If you are currently experiencing itchiness as a symptom of your liver injury:
- You will be asked to complete an Itching Questionnaire (48 questions) which will also be repeated by phone at the same time as the health questionnaire.
- If you consent to DNA genetic analysis, they will collect a 5ml blood sample (Optional)
After the study visit: If you agree, the Nottingham research team will contact you by phone a further 4 times (after approx. 1 week, 4 weeks, 3 months, and 6 months) to repeat the health questionnaire and itching questionnaire (if applicable) taking around 15 mins. If after 6 months your symptoms continue you will be asked to continue to complete questionnaires every 3 months for up to 2 years.
If itching only develops after the first study visit, a further visit can be arranged. At this visit a blood sample will be taken for testing and the itching questionnaire completed as done for other itching cases. If the results of clinical testing done on the study day show that your liver function has recovered and does not meet the research inclusion criteria, we will no longer need you to take part in the follow-up research activities. You will continue to have the required clinical care and we will still provide the genetic test results, if done. If your sample has not been sent for analysis it will be disposed of.
What will happen to my samples?
Blood samples collected from people who report itching will be sent for gentic analysis.This analysis will be done in the UK. They will not share the results of the test with anyone else.
For patients with itching symptoms, we will assess 77 different genetic markers, which are thought to be linked to rare, treatable inherited liver diseases that cause itching. This testing is optional. In the rare event that there are any clinically significant findings, this will be discussed with your care team. If the tests reveal any medical condition, your care team will discuss this with you and will provide appropriate genetic specialist follow up care for you and your family.
What will happen to the results of the research study?
The results will be reported to the funders, published and presented at scientific meetings and in student presentations/dissertations/PhD theses; which will be available for further dissemination.
All data will be anonymised. A summary will also be available on the NIHR Nottingham BRU website and associated University of Nottingham social media platforms. The results of the study will be registered at ClinicalTrials.gov.
A summary, will also be sent to participants who consent to future contact.
Please View the Patient Information Sheet for more Information