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RecruitingOBSERVATIONAL

Nutrition and Clinical Outcomes in IBD

This study aims to understand how your nutrition and body health affect outcomes for people with Inflammatory Bowel Disease (IBD), which includes Crohn's disease and ulcerative colitis. Many IBD patients experience poor nutrition, which can make their condition worse or lead to problems after surgery. We're looking at different ways to check nutritional status and see if they predict how well people respond to treatments or recover from surgery. Participants will have their nutrition and body health assessed when they start a new treatment or before surgery, and again at a follow-up visit. This is an observational study, meaning you won't get new treatments or extra tests beyond your usual care. We hope to find better ways to spot and help with nutrition problems in IBD.

At a glance

Status
Recruiting
Sponsor
Barts & The London NHS Trust
Enrolment target
300
Start
24 Oct 2024
Estimated completion
01 Dec 2028

What is this study about?

If you live with Inflammatory Bowel Disease (IBD), such as Crohn's disease or ulcerative colitis, you know how challenging it can be. This study wants to explore a really important, but often overlooked, part of managing your IBD: your nutrition and body health. Many people with IBD struggle with getting enough nutrients, which can affect how well treatments work, your chances of needing surgery, or how you recover afterward. Currently, doctors don't have the best tools to spot these nutrition problems early on.

This study isn't about trying a new medication, but rather about carefully observing and comparing different ways to check if someone with IBD is well-nourished or not. We'll be looking at things like your body composition – that's the balance of muscle and fat in your body – which can be an important indicator of your overall health and how your body handles illness or treatment. We also want to see if these nutritional assessments can predict how you'll respond to new advanced medical therapies or to surgery.

By gathering this information, researchers hope to find the best and most accurate ways to measure nutritional health in IBD patients. This could lead to better guidelines for doctors so they can identify and help people with nutritional problems sooner. Ultimately, the goal is to improve how IBD is managed, help patients feel better, and reduce the risk of complications from their disease or treatment.

Key takeaways

  • Study focuses on nutrition and body health in IBD patients.
  • Aims to find better ways to detect poor nutrition in Crohn's and Colitis.
  • It's an 'observational' study, no new treatments or extra invasive tests.
  • Participation involves two assessments during regular hospital visits.
  • Could help improve future IBD care and patient outcomes.
  • You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 16 years old and have been diagnosed with Inflammatory Bowel Disease (IBD), which includes Crohn's disease, ulcerative colitis, or IBD-U (a type where it's not clearly Crohn's or colitis).

We are specifically looking for people who are either starting a new advanced medication for their IBD or who are going to have surgery related to their IBD. You must also be able to understand the study information and agree to take part in writing.

Unfortunately, you can't join if you are under 16, can't give informed consent, have a pacemaker or internal defibrillator, or have active cancer or another illness causing severe weight and muscle loss.

Quick self-check
  • Are you 16 years old or older?
  • Do you have Crohn's disease, ulcerative colitis, or IBD-U?
  • Are you starting a new advanced IBD medication or having IBD-related surgery?
  • Can you understand the study information and agree to take part in writing?
  • Do you NOT have a pacemaker, internal defibrillator, or active cancer?
  • Do you NOT have another condition causing severe weight/muscle loss?

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, you won't need any extra hospital visits or invasive tests beyond what your doctor would normally do for your IBD care. This is an 'observational' study, meaning we're just gathering information about your health as you go through your usual treatment.

You will have two main assessments. The first will happen before you start your new advanced medication or before your IBD-related surgery. The second assessment will take place at a scheduled follow-up appointment with your doctor. These assessments will involve measuring your nutritional status and body make-up. There are no new medications involved, and the total duration of your participation will depend on your standard follow-up schedule.

Potential risks and benefits

Taking part in this study carries very minimal risks, as you won't be undergoing any procedures or tests that aren't already part of your routine medical care. The main benefit is that you'll be contributing to important research that could improve care for all IBD patients in the future, particularly in how we identify and manage nutritional problems. Remember, your participation is completely voluntary, and you can withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Barts Health NHS Trust
    London, United Kingdom· Recruiting

Common questions

What is IBD?

IBD stands for Inflammatory Bowel Disease, which is a lifelong condition where parts of your digestive system become inflamed. The two main types are Crohn's disease and ulcerative colitis.

What does 'observational study' mean?

It means researchers will observe and collect information about your health and treatment journey without giving you any new medicines or procedures that aren't part of your standard care.

Will I get any special treatment?

No, this study doesn't involve new treatments. You will continue to receive the standard care from your doctors as usual.

How long will I be in the study?

Your participation will involve two assessments: one at the start of new treatment/before surgery, and one at a usual follow-up appointment. The total duration depends on your normal clinical schedule.

Will my information be kept private?

Yes, all your personal information and health data will be kept strictly confidential and anonymous to protect your privacy.

How to find out more

Sarah Faloon, MBChB

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

Interested in taking part?

Register your interest

Share your details and the research team for "Nutrition and Clinical Outcomes in IBD…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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