RecruitingObservational

LYME-UK – A study of early Lyme disease within GPs in the UK

The LYME-UK study aims to better understand Lyme disease, a common infection spread by tick bites in the UK. Despite growing awareness, we don't fully know how many people are affected, the best ways to diagnose it, or the long-term effects. This study will follow adults who see their GP with suspected Lyme disease and are treated with antibiotics. Participants won't have their standard treatment changed. Over 12 months, researchers will collect blood and urine samples and ask about symptoms. The information gathered will help improve diagnosis and treatment for Lyme disease in the future, with the goal of helping more people get better care.

At a glance

Status

Recruiting

Sponsor

University of Liverpool

Enrolment target

Start

26 Jul 2023

Estimated completion

31 Mar 2029

Lyme disease

What is this study about?

Lyme disease is an infection caused by bacteria spread through the bite of an infected tick. It's the most common tick-borne infection in the UK, as well as in Europe and North America. Even though more people are hearing about Lyme disease, doctors and scientists still don't have all the answers. For example, we don't fully know how many people in the UK get Lyme disease, the best ways to accurately diagnose it, or what happens to people years after they've been infected.

That's where the LYME-UK study comes in. Its main goal is to learn more about Lyme disease in the UK. Researchers want to understand how the illness progresses and how well current treatments work over the course of a year. They will be looking at adults who visit their local doctor (GP) because they think they might have Lyme disease and are then given antibiotics.

By gathering this information, the study hopes to provide a clearer picture of Lyme disease in the UK. This will help improve how doctors diagnose the condition and make sure patients get the best possible treatment, leading to better outcomes for everyone affected.

Key takeaways

The study focuses on early Lyme disease diagnosed by GPs in the UK.
It aims to improve understanding of diagnosis and treatment outcomes.
Participation involves 3 clinic visits for samples and questionnaires over 12 months.
Your standard medical treatment will not be altered.
The study helps future patients, though there's no direct personal health benefit for you.
Travel costs up to £20 per visit will be reimbursed.

Who may be eligible?

This study is looking for adults aged 18 or older who are being treated by their GP because their doctor suspects they have Lyme disease. To take part, you need to be able to attend follow-up appointments for blood and urine samples, and be willing to answer questions through questionnaires.

You also need to be able to understand and agree to take part in the study yourself, and be able to take care of yourself and get around without constant help.

However, some people won't be able to join. This includes anyone who can't have blood samples taken, people who are very unwell or have serious long-term health problems with a very short life expectancy, or those who are already taking antibiotics for a long time for another condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your GP suspected you have Lyme disease and started you on antibiotics?
Are you able to attend appointments for blood and urine samples?
Are you able to fill out questionnaires about your health?
Are you able to agree to take part in the study yourself?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be followed for up to 12 months. Your regular treatment for Lyme disease will not be changed. You will need to attend three appointments at a clinic to provide blood and urine samples. For some people, there's an optional extra step at the very beginning: you might be asked if you'd agree to have a small skin sample (called a biopsy) taken. This is entirely up to you.

Throughout the 12 months, you'll also be asked to complete questionnaires about your symptoms at ten different times. These questionnaires help the researchers understand how you're feeling over time. Your total involvement could last about a year, but the main clinic visits are limited to three, plus the optional skin biopsy appointment.

Potential risks and benefits

While there is no direct personal health benefit for taking part, your contribution is really important! The information you provide will help scientists learn more about Lyme disease in the UK, hopefully leading to better ways to diagnose and treat it in the future. You'll also get up to £20 per visit to help cover your travel costs. There are a few small risks to consider: giving blood can be a little uncomfortable and might cause a small bruise. If you choose to have the optional skin biopsy, there's a small risk of discomfort from the procedure and a tiny chance of infection. You might also need an extra visit to check how it's healing or to remove any stitches. Remember, you can decide to stop taking part at any time.

Locations (1)

NHS Highland
Approximate
Inverness, Scotland

Common questions

What is Lyme disease?

Lyme disease is an infection caused by bacteria spread to humans through the bite of an infected tick.

Will my treatment change if I join the study?

No, your standard treatment for Lyme disease from your doctor will not be changed if you participate in this study.

Do I have to have a skin biopsy?

No, a skin biopsy is completely optional. You can still take part in the study without having one.

What is the main goal of this study?

The study aims to understand more about Lyme disease in the UK, including how it's diagnosed, how many people are affected, and what the long-term effects are, to improve future care.

Will I get paid for taking part?

You won't be paid for your time, but you will be reimbursed up to £20 per visit to help with your travel costs.

How to find out more

Rampy Kumar

Lymeuk@liverpool.ac.uk +44 151 705 3755 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.