RecruitingOBSERVATIONAL

Mechanism of Chronic Pain in Patients With IBD

Abdominal pain is a common issue for people with Inflammatory Bowel Disease (IBD), even when their condition is not flaring up. This study wants to understand why this happens and what causes this ongoing, or chronic, pain. Researchers will look at different things like a person's body (biological factors), their thoughts and feelings (psychological factors), and their genes. The goal is to find out what puts people with newly diagnosed IBD at risk of developing long-lasting pain. They will follow participants over time, collecting information through questionnaires, samples, and heart rate monitoring, to get a clearer picture of this complex problem.

At a glance

Status

Recruiting

Sponsor

Queen Mary University of London

Enrolment target

25,600

Start

26 Jul 2021

Estimated completion

30 Sep 2027

Inflammatory Bowel Diseases

What is this study about?

If you live with Inflammatory Bowel Disease (IBD), you might know how common tummy pain can be. For many people, this pain goes away when their IBD is well-managed. However, for a significant number of people, the pain sadly continues even when their IBD isn't active. Right now, doctors and scientists don't fully understand why some people experience this ongoing (or 'chronic') pain.

This research project aims to get to the bottom of this mystery. It will explore various aspects to see what might be linked to developing long-lasting pain in people with newly diagnosed IBD, specifically ulcerative colitis and Crohn's disease. The study will investigate factors related to the 'brain-gut axis' – that's the complex two-way communication system between your brain and your digestive system. They'll also look at things like your genes, your overall well-being, and other physical factors.

By gathering lots of information from people over time, this study hopes to identify early warning signs or 'risk factors' for chronic pain. Understanding these factors could help doctors better support people with IBD in the future, potentially leading to new ways to prevent or manage this difficult symptom.

Key takeaways

Study aims to understand ongoing tummy pain in IBD, even when not flaring.
Looking at mind, body, and genes to find causes of pain.
Designed for adults with recently diagnosed Crohn's or ulcerative colitis.
Involves online questionnaires, heart rate tracking, and possibly samples over 18 months.
Your participation could help improve future care for people with IBD.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with either Ulcerative Colitis (UC) or Crohn's Disease (CD) within the last six months. It’s important that you have access to the internet and are comfortable using a computer or smartphone to fill out questionnaires.

There are certain situations that would mean you can't join the study. For example, if you have very severe colitis that might need surgery soon, or if you already have a colostomy/ileostomy bag. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period also cannot take part. Additionally, if you have other serious health conditions that might interfere with the study's results, or a history of substance abuse, you wouldn't be eligible.

The researchers want to make sure that everyone participating is able to complete the study safely and that the results are as accurate as possible. They will ask some questions about your health to make sure it's the right study for you.

Quick self-check

Are you 18 years old or over?
Have you been diagnosed with Crohn's disease or ulcerative colitis within the last 6 months?
Do you have reliable internet access and feel comfortable using apps and online forms?
Are you able and willing to take part for around 18 months, including regular online questionnaires?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study involves a few different steps over about 18 months. Initially, you'll have an online video chat with the research team to go through the consent form and learn how to use some online tools. You'll be shown how to fill out questionnaires about your symptoms, mood, and health, and how to use a smartphone app to record your heart rate and daily gut symptoms for 7 days.

After this initial setup, you'll complete detailed online questionnaires at the start. For the next 7 days, you'll also use the smartphone app to answer short questions at random times throughout the day and record your heart rate once a day. This entire process (filling out questionnaires and using the app for 7 days) will be repeated every 6 months for 18 months. Some parts of the study also involve providing stool and blood samples. The research team will guide you through all these steps and tell you what to expect at each stage. You might be asked if you'd like to continue answering questionnaires online for a longer period, up to 36 months, if you wish.

Potential risks and benefits

Taking part in this study could help us learn more about why some people with IBD experience ongoing pain, which might lead to better care in the future. As a participant, you'll be contributing to important medical research. There are no direct personal benefits or new treatments offered in this study. The risks are generally low, mainly involving the time commitment for questionnaires and providing samples, and potentially some discomfort during blood tests. You might also find some questions about your symptoms or feelings a little personal. You are always in control and free to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Neurogastroenterology, Barts and the London School of Medicine and Dentistry, Queen Mary University of London
London, United Kingdom· Recruiting

Common questions

What is IBD?

IBD stands for Inflammatory Bowel Disease, which includes conditions like Crohn's disease and ulcerative colitis, where your gut becomes inflamed.

What is 'chronic pain'?

Chronic pain means pain that lasts for a long time, often several months or more, even if the original cause seems to be under control.

What is the 'brain-gut axis'?

This is the continuous communication system between your brain and your digestive system. They affect each other, which can impact symptoms like pain.

Will I get paid for taking part?

The information provided does not mention any payment for participation. You are contributing to research.

Who is funding this study?

The information provided for this specific trial does not mention the funding source.

How to find out more

Iman Khwaja

i.khwaja@qmul.ac.uk 02078822655 Official trial record

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