For adults aged 18–75 with a confirmed coeliac disease diagnosis who still experience symptoms despite following a strict gluten-free diet. Conducted at our Sippy Downs, Brisbane and Morayfield clinics.
New hope for people with coeliac disease who still feel unwell on a gluten-free diet
Coeliac disease is a serious autoimmune condition in which gluten triggers an immune response that damages the lining of the small intestine. It affects approximately 1 in 70 Australians, yet only 20% of those with the condition have been diagnosed. For those who are diagnosed, a strict gluten-free diet is currently the only treatment available. But for many, that's not enough.
A significant number of people with coeliac disease continue to experience symptoms like bloating, tummy pain, constipation, diarrhoea, and nausea, even after months or years of following a gluten-free diet. Right now, there are no approved medicines to address these ongoing symptoms. This trial has been shaped by feedback from people living with coeliac disease, focusing on improving quality of life, evaluating an investigational injection that may help reduce persistent symptoms in people who haven't found full relief through diet alone.
As part of the trial, participants will take two capsules three times per week with their evening meal to simulate accidental gluten exposure. Each dose contains approximately 250mg of gluten, about the same as two small bites of white toast, administered in a controlled and safe way.
Eligibility
Do you qualify?
Aged 18–75
Medically diagnosed with coeliac disease
Following a gluten-free diet for at least 12 months
Still experiencing symptoms such as bloating, constipation, diarrhoea, nausea, or stomach pain in the last month
BMI between 18 and 40
Willing to undergo two endoscopy procedures with small bowel biopsies, one at the start and one at the end of the study
Willing to consume small controlled amounts of gluten three times per week during the study
What's involved
Commitment and procedures
Visit type
day visits
total visits
15
duration
12 months
treatment
injection
procedures
Physical examination
Vital signs monitoring
Blood test
2x endoscopy procedures
Daily symptom check-ins via phone or tablet
Regular clinic visits for study injections
treatment design
Eligible participants will be randomly assigned to receive either the investigational injection or a placebo, with a 50% chance of receiving either. The injection is administered under the skin every two to four weeks over the course of the 12-month trial.
As part of the study protocol, participants will take two gluten capsules three times per week with their evening meal, each containing approximately 250mg of gluten, equivalent to about two small bites of white toast, to simulate accidental gluten exposure in a controlled and safe way. Two endoscopy procedures with small bowel biopsies will be performed, one at the start and one at the end of the study. Daily symptom check-ins are completed at home via phone or tablet. All procedures will be explained clearly, and participants can ask questions at any time.
More information
Have questions? We're here to help.
Contact our recruitment team directly, they're happy to answer any questions before you apply. Please do not send personal medical information by email.
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