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.
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.
