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Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD

This study explores how the salt you eat could impact Crohn's disease. It aims to discover if a higher salt intake increases the breakdown of proteins in your gut, potentially making inflammation and symptoms worse. By understanding the connection between salt, gut bacteria, and swelling in the gut, the researchers hope to develop better dietary guidance for people living with Crohn's. This research might help identify specific foods that influence the disease, leading to more personalised eating plans that could improve your health and well-being.

At a glance

Status
Not yet recruiting
Sponsor
McMaster University
Enrolment target
300
Start
18 Sep 2025
Estimated completion
01 Sep 2029

What is this study about?

You might be wondering how your everyday diet impacts your Crohn's disease. This study is all about understanding the connection between the salt you eat and how your gut behaves, especially when you have Crohn's disease. The main idea is to see if eating more salt could lead to more irritation and swelling (inflammation) in your gut, and potentially make your symptoms feel worse. This happens by looking at how proteins in your gut might break down more.

The researchers are also interested in how salt affects the tiny living organisms (bacteria) in your gut. By carefully studying these links between salt, gut bacteria, and inflammation, the study aims to give clearer, more helpful advice about diet for people with Crohn's. The hope is that this research will help find out which foods might be better or worse for you and lead to more personalised eating plans.

Ultimately, knowing more about how salt and diet affect Crohn's could lead to new ways of managing the condition and improving your quality of life. It could help doctors and dietitians offer more specific advice tailored to individual needs.

Key takeaways

  • Researchers are investigating the link between salt intake and Crohn's disease.
  • The study aims to understand inflammation and gut bacteria changes related to salt.
  • Participation involves giving samples (blood, urine, stool) and diet tracking.
  • Some participants will have a colonoscopy as part of the study.
  • The goal is to develop better, more personalised diet advice for Crohn's patients.

Who may be eligible?

To be considered for this study, you need to be an adult between the ages of 18 and 70. You must have a confirmed diagnosis of Crohn's disease. It's also important that you are willing and able to understand and sign a consent form before starting, and that you can comfortably follow all the study's instructions, as judged by the research team.

There are also some reasons why you might not be able to join. For example, if you've recently taken antibiotics, other anti-bacterial medicines, or probiotics within the last eight weeks, you wouldn't be able to participate. The study also cannot include pregnant individuals or anyone with current issues like alcohol or drug abuse.

Additionally, if you have other serious health problems, or if blood test results show something that the researchers think could put you at risk or get in the way of collecting accurate information for the study, you would not be eligible to take part.

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.

  1. Are you between 18 and 70 years old?
  2. Do you have a diagnosis of Crohn's disease?
  3. Have you avoided antibiotics, anti-bacterial medicines, or probiotics in the last 8 weeks?
  4. Are you able to attend appointments and follow study instructions?
  5. Are you not currently pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves two main parts over a couple of years. In the first part, about 300 people with Crohn's disease will have their diet assessed, specifically focusing on how much salt they eat. You'll also provide stool samples to check gut health.

For two years, you'll have yearly check-ups. At these visits, you'll answer questions about your health, give blood, urine, and stool samples, and tell researchers about what you've eaten recently. If you have a flare-up of your Crohn's, you might have extra visits.

Around 80 people from the first group will then be invited to take part in a shorter, more detailed second phase. This will involve three visits over two weeks where you'll continue to provide samples. At the end of this two-week period, you'll also have a colonoscopy, which is a procedure to look at the inside of your bowel. Throughout this phase, your diet will be very closely monitored. After this second phase, you'll return to the regular yearly check-ups from the first part of the study.

Potential risks and benefits

Taking part in a study like this might offer a chance to contribute to new knowledge about Crohn's disease and potentially help others in the future. While there are no guaranteed personal health benefits, your participation is valuable. The procedures involved, such as blood tests, urine collections, and colonoscopies, carry small risks, such as discomfort from blood draws or the usual risks associated with a colonoscopy. All procedures will be explained in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • McMaster University Medical Centre
    Verified postcode
    Hamilton, Canada

Common questions

What is the main goal of this study?

The main goal is to understand if eating salt affects gut inflammation and symptoms in people with Crohn's disease.

How long will I be involved in the study?

The main part of the study involves annual check-ups for two years. Some participants will have a shorter, more intensive phase within that period.

Will I have to change my diet?

For most of the study, you'll just report what you normally eat. For a short, specific part, your diet might be more closely monitored.

What kind of tests will I have?

You'll have blood, urine, and stool tests. Some participants will also have a colonoscopy.

Who is funding this research?

Details on specific funding sources are not provided in this summary, but medical research is typically supported by government grants or health organisations.

How to find out more

Gaston H Rueda, MD

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 "Protease Regulation and Impact of Sodium as Mechanisms of In…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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