Do you have coeliac disease and still feel unwell, even though you follow a strict gluten-free diet?

You’re not alone. Many Australians with coeliac disease continue to experience symptoms like tummy pain, bloating, constipation, diarrhoea, nausea, even after avoiding gluten. Right now, there are no approved medicines to treat these ongoing symptoms. That is why UniSC Clinical Trials is conducting a new clinical trial to test a potential new treatment option.

Coeliac disease is a serious autoimmune condition where gluten triggers damage to the small intestine. Affecting about one in 70 Australians, but most remain undiagnosed. If left untreated, coeliac disease can lead to long-term health complications such as osteoporosis, liver disease, and infertility.

This trial has been shaped by feedback from people living with coeliac disease and is focused on improving quality of life. If you’re eligible, you’ll be reimbursed for your time and supported throughout the trial. Taking part in this research could help improve future treatment options for the coeliac community.

You may be eligible for the trial if you:

• are aged 18 to 75
• have a Body Mass Index (BMI) between 18 and 40
• have been medically diagnosed coeliac disease and have been attempting to follow a gluten-free diet for at least 12 months.
• still have symptoms like bloating, constipation, diarrhoea, nausea or stomach pain in the last month.
• are willing to have small amounts of gluten (in a safe way) during the study*
• are willing to have two endoscopy procedures with biopsies – one at the beginning and one at the end of the study
• can attend up to 15 visits at our Morayfield, Sippy Downs or Brisbane clinic over 12 months.

* Participants will be asked to 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.

Our participant recruitment team will call you to ask you more questions to determine if you are eligible for the trial.

Eligible participants will be reimbursed up to $3,400 for their time and contribution to the trial.

To register your interest, please review the application form and complete your details.

This trial has been reviewed by an independent Human Research Ethics Committee.

What's involved?

This is assessing the effectiveness of an investigational medication administered by injection that could reduce symptoms for those struggling with coeliac disease despite attempting to following a gluten-free diet for the last 12 months. There is a 50% chance of receiving either the investigational treatment or a placebo.

Procedures:

• Medical history review and physical examination
• Blood tests to check general health and coeliac-related markers
• Two endoscopy procedures with small bowel biopsies (one at the start, one at the end)
• Daily symptom check-ins using a phone or tablet
• Regular clinic visits for monitoring and study injections
• Eating small amounts of gluten (in a controlled and safe way) three times per week

The investigational treatment is given as an injection under the skin every two to four weeks over the course of the trial.

The trial will be overseen by our Medical Investigators and supported by our Clinical Trials Coordinators.

Where can I find more information?

More information can be requested by contacting the recruitment team on 07 5409 8640. Alternatively, the team will be more than happy to answer any questions you may have when they call.