Clinical trial gives hope to the 1 in 70 Australian Coeliac sufferers

A long-awaited clinical trial being conducted at Wesley Medical Research may help define a safe level of gluten exposure for all.

Currently, the only treatment for coeliac disease is strict, lifelong avoidance of foods containing gluten, such as bread, pasta, and biscuits.

However, Wesley Medical Research lead investigator Associate Professor James Daveson is currently recruiting patients to determine the level of gluten that coeliac sufferers can safely tolerate.

“It is interesting that there is actually limited data defining what is a safe level of gluten exposure for people suffering from Coeliac Disease,” A/Prof Daveson said.

“Whilst it may prove to be that the current Australian and New Zealand guidelines of no detectable gluten at all continues to be the guidance for people with Coeliac Disease, it has only been over the last couple of years that we have developed new methods which will help us accurately define this.

“We still don’t know the minimal amount of gluten that causes acute symptoms, gut damage and immune activation and global safety food guidelines for people with Coeliac Disease varies.”

This Gluten Threshold Study could have a profound influence on food labelling standards in Australia and New Zealand – and potentially worldwide.

“I would do a happy dance every day,” says Jane Dodwell, who is participating in the trial. “It’s not about wanting to eat doughnuts; it’s about having dinner with friends without worrying about how sick I could get if the restaurant has put Gluten Free on the menu when it is really only Gluten Friendly.”

Wesley Medical Research CEO Dr Claudia Giurgiuman said the uncertainty over the safe dose of gluten for patients with coeliac disease had led to food only being labelled as “gluten-free” in Australia and New Zealand if it contains “no detectable gluten”. In contrast, the accepted standard in Europe and the United States is that food containing gluten up to 20 parts per million can be labelled “gluten-free”.

“I am thrilled that this study has commenced as it could be a game-changer for coeliac patients, not just here in Australia but globally as well,” she said.

Announcing next steps today, A/Prof James Daveson said the Gluten Threshold Study could provide the evidence needed to establish a firm position on the gluten free standard in Australia and New Zealand.

“1 in 70 Australians have coeliac disease, though unfortunately up to 80% of cases remaining undiagnosed,” Dr Daveson said.

“If left untreated, coeliac disease is associated with a 3-fold increased risk of autoimmune diseases, osteoporosis and malignancy, decreased quality of life, and a 2 to 4-fold increase in mortality.”

The Gluten Threshold Study is funded by Coeliac Australia and other generous Wesley Medical Research donors.

Please contact Wesley Medical Research to participate in the Gluten Threshold Study if you are:

• Aged between 25 and 75 years
• Have biopsy-proven coeliac disease
• Have been on a gluten-free diet for at least 2 years
• Are willing to be challenged with small amounts (up to 1 gram) of gluten
• Are willing to attend study visits at Wesley Medical Research in Brisbane

If you are interested, please email clinicaltrials@wesleyresearch.org.au  or call 07 3271 1500 for further information.