Coeliac disease clinical studies

Coeliac disease clinical studies

Photo of a clinician speaking to a clinical trial participant
Our researchers are leading clinical studies into coeliac disease.
We are currently looking for people in any of the following categories. Please register your interest and we can talk to you about what studies are available.
  1. Coeliac disease – treated: aged 18-75 and have coeliac disease and are following a gluten-free diet
  2. Coeliac disease – non-responsive/refractory: aged 18-75 and have coeliac disease and are not getting better despite following a gluten-free diet
  3. Coeliac disease – active: aged 18-75 and have coeliac disease that has recently been diagnosed or are awaiting a gastroscopy to confirm diagnosis
  4. Gluten/wheat sensitivity: aged 18-75 and are sensitive to gluten or wheat (coeliac disease may or may not have been excluded)
  5. Autoimmune disease: aged 18-75 and have one or more autoimmune diseases such as type 1 diabetes, lupus or autoimmune thyroid disease, separate (or in addition to) coeliac disease
  6. People aged 18-75 with none of the issues above

Most studies involve one or more visits to WEHI or the Royal Melbourne Hospital in Parkville but alternate options can be available and we will work with you on a time that is suitable. Free parking is available and an attendance certificate can be provided.

Our coeliac research is only possible because of the dedication and generosity of our all participants and we are extremely grateful for those who have supported our cause. We would be delighted to tell you about our studies, welcome you to our research and get you involved!

Do I have to do a gluten challenge?

Gluten challenge involves consuming gluten, either once or over a period of time. Measuring the responses to a gluten challenge provides important information about what is happening in the bodies of people with coeliac disease or gluten sensitivity. It is an effective way of triggering an immune response in people with coeliac disease which allows the immune cells to be collected and studied in a test tube (Figure 1). Gluten challenge can also be used by doctors to help with the diagnosis of coeliac disease. 

Side by side comparison of T cells
Figure 1: Testing gluten specific T cells
A. Prior to gluten challenge, no gluten specific immune cells are detectable in the blood.
B. After a gluten challenge, gluten specific immune cells can be isolated and studied, providing a wealth of information.

We generally employ short gluten challenges that involve consuming gluten on a single occasion or over up to three days. We will collect blood either the same day, or several days later. The cells and components we isolate from the blood are valuable and allow us to learn about how these immune cell behave and also test new treatments for how well they may help people with coeliac disease.

A gluten challenge allows us to test how well a drug might work in someone with coeliac disease without the person having to actually take the drug. The information allows us to work out which potential treatments are promising and should be taken forward into clinical development.

A gluten challenge can be associated with unpleasant symptoms in people with coeliac disease and gluten sensitivity such as nausea, bloating, diarrhoea and fatigue. Symptoms are generally mild and settle over the course of the day, however occasionally can be more prominent. For example, some people can vomit. Although these symptoms are unpleasant, short-term gluten exposure carries no risk of long-term problems. For most people, symptoms typically settle within a day or two even if gluten continues to be consumed. Our team will support you throughout the challenge. Many people are surprised that the challenge was better tolerated than they anticipated.

We appreciate not everyone is able to participate in a gluten challenge but would still like to help. Not all of our studies involve a gluten challenge. Please have a chat to use about what studies may work for you!

Dr Jason Tye-Din with clinical patient

More than half of Australians have genetic risk factors for developing coeliac disease