For adults aged 18–80 with diagnosed coeliac disease who continue to experience symptoms despite following a strict gluten-free diet for at least 12 months. Conducted at our South Bank, Sippy Downs and Morayfield clinics.
A potential new treatment for coeliac symptoms that persist despite a gluten-free diet
Coeliac disease is a serious autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, rye, barley, and oats, causing damage to the lining of the small intestine. It affects around 1 in 70 Australians, yet an estimated 80% remain undiagnosed. For those who are diagnosed, a strict gluten-free diet is the only currently available treatment. But for many people, that's not enough.
Even among those following a gluten-free diet, symptoms such as bloating, abdominal pain, diarrhoea, and nausea can persist, often due to accidental or unavoidable gluten exposure in everyday life. Currently, there are no approved medicines to address these ongoing symptoms.
This trial is evaluating ZED1227, an investigational oral tablet, for its ability to reduce the severity of symptoms caused by gluten exposure in people with coeliac disease who are already following a gluten-free diet. This is a different trial from other coeliac studies on our site. It does not involve deliberate gluten loading and focuses specifically on people whose symptoms continue despite dietary compliance.
This trial is specifically for people who are already following a gluten-free diet but still experience symptoms. It does not involve deliberate gluten exposure. The investigational treatment (ZED1227) is being evaluated for its ability to reduce symptoms from accidental or unavoidable gluten exposure.
Eligibility
Do you qualify?
Aged 18–80
Diagnosed with coeliac disease. Must be able to provide biopsy or blood test documentation confirming diagnosis made at least 12 months ago
Following a gluten-free diet for at least 12 months
Experiencing at least one moderate or severe gastrointestinal symptom (diarrhoea, abdominal pain, bloating, or nausea) in the last 4 weeks
BMI between 17 and 35
Currently taking certain medications that affect drug absorption or metabolism, such as certain antifungals, antivirals, or antibiotics, or medicines aimed at reducing glutening symptoms (e.g. Glutegard)
Not sure if your medications are affected? Our recruitment team will discuss this with you during the phone screening call; don't let this stop you from applying.
What's involved
Commitment and procedures
Visit type
day visits
total visits
7 + 2 endoscopies
duration
23 weeks
treatment
Tablet
procedures
Physical examination
Vital signs monitoring
Blood samples
Urine sample
Gastro symptom assessment
Questionnaires
treatment design
Eligible participants will be randomly assigned in a double-blind, placebo-controlled design to receive either the drug tablet (ZED1227) or a placebo tablet. Neither participants nor the study team will know which treatment is being taken.
The purpose of the trial is to evaluate the efficacy and tolerability of ZED1227 in adults with coeliac disease who continue to experience symptoms despite following a gluten-free diet. Participants will attend clinic visits at our South Bank, Sippy Downs, and Morayfield clinics. 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 to the coeliac symptom relief trial. Please do not send personal medical information by email.
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