RecruitingOBSERVATIONAL

NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

This study, called NAZA, is looking at people with Crohn's disease or ulcerative colitis (together known as IBD) and healthy individuals to compare certain markers in their bodies related to inflammation. The main goal is to understand if there are differences in these inflammatory markers between the two groups. For IBD patients, the study focuses on those who are switching to new types of biologic treatments. Researchers hope that by analysing blood, stool, and tissue samples, they can gain a better understanding of IBD. This knowledge could help predict how patients might respond to different treatments and ultimately lead to improved ways of managing these conditions in the future.

At a glance

Status

Recruiting

Sponsor

University of Nottingham

Enrolment target

240

Start

12 Dec 2022

Estimated completion

28 Feb 2027

Gastro-Intestinal Disorder Crohn Disease Ulcerative Colitis Inflammatory Bowel Diseases

What is this study about?

The NAZA study is designed to help us better understand inflammatory bowel diseases (IBD), which include Crohn's disease and ulcerative colitis. In this study, doctors are looking at how inflammation markers in the body differ between people with IBD and those without it. Specifically, they're interested in patients with moderate to severe IBD who are starting new, advanced biologic treatments, as well as people without IBD who are having a routine bowel check-up.

The main idea is to collect samples like blood, stool, and small tissue pieces from both groups. By carefully studying these samples, researchers hope to identify specific features and changes inside the body that might be linked to how well a person with IBD responds to treatment. This could help doctors predict the course of the disease and decide which treatment might work best for each individual.

Ultimately, the information gathered from this study is expected to improve our overall understanding of IBD. This could lead to more effective treatments and better ways to manage the condition, helping patients feel better and have a better quality of life.

Key takeaways

This study helps understand Crohn's and ulcerative colitis (IBD).
It compares inflammation markers in people with IBD and healthy individuals.
Participants with IBD are starting new 'biologic' treatments.
Samples (blood, stool, tissue) provide clues for better treatment.
Findings could lead to improved IBD care and prediction of treatment response.

Who may be eligible?

You might be able to take part in this study if you are at least 16 years old. For people with Crohn's disease or ulcerative colitis, you would need to have moderate to severe disease and be about to start a new type of advanced biological treatment, such as anti-TNF therapy, ustekinumab, upadacitinib, or vedolizumab.

If you don't have IBD, you could still be eligible if you are having a routine colonoscopy, for example, as part of a bowel cancer screening program, and no problems are found during your examination.

However, there are reasons you might not be able to join, such as if you cannot give your informed consent, have certain infections like hepatitis B or C, HIV, or an active COVID-19 infection. You also can't participate if you've had a cancer diagnosis, a transplant, a blood transfusion recently, or are pregnant. If you have been in another medical study involving a new medication within the last three months, or if the study doctor thinks it's not suitable for you, you won't be able to join.

Quick self-check

Are you at least 16 years old?
Do you have moderate to severe Crohn's or ulcerative colitis and are starting a new biologic treatment soon?
OR are you having a routine colonoscopy and don't have IBD?
Have you been free from serious infections recently, including active COVID-19?
Are you not pregnant and haven't had recent transfusions or transplants?

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, your involvement will depend on whether you have IBD or not. If you have Crohn's disease or ulcerative colitis, you will provide blood and stool samples, and some extra small tissue samples will be taken during your routine endoscopy procedures. These samples will be collected at three different times: when you first join (called 'baseline'), after 3 months, and again after 12 months. This means your participation will last for about a year.

If you are a healthy control participant, you will provide a blood sample, a stool sample, and some extra tissue samples during your routine colonoscopy. For control participants, these samples are usually taken just once.

There won't be any new medications given as part of this study; it's about observing and collecting information while you receive your standard care. The samples will be analysed to look for clues about how your body works and how you might respond to treatments.

Potential risks and benefits

Taking part in this study might not directly benefit you, but the information gained could help future patients with IBD by improving our understanding of the condition and leading to better treatments. The main potential risks involve the extra blood draws and tissue samples, which are generally very safe procedures but carry a small chance of minor discomfort, bruising, or bleeding. You are free to withdraw from the study at any time without giving a reason, and this will not affect your routine medical care.

Locations (1)

University of Nottingham
Nottingham, United Kingdom· Recruiting

Common questions

What is an 'inflammatory marker'?

Inflammatory markers are substances in your body that can increase when there's inflammation, like a chemical signal that your body is fighting something.

Will I have to take any new medicine if I join this study?

No, this study does not involve giving you new medicines. It's about observing people and collecting samples while you receive your usual medical care.

What is a 'biologic therapy'?

Biologic therapies are advanced medicines made from living organisms that target specific parts of the immune system to reduce inflammation, often used for conditions like IBD.

How long will I be involved in the study?

If you have IBD, you'll be involved for about 12 months with samples taken at three different times. If you don't have IBD, your involvement will likely be a single visit.

Who will see my study results?

The results from your samples will be used for research to understand IBD better. Your personal information will be kept private, and your name won't be linked to any published results.

How to find out more

Gordon Moran Professor

Gordon.Moran@nottingham.ac.uk 0115 9249924 Official trial record

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