Coeliac Disease

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Coeliac Disease

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Have you been diagnosed with Coeliac Disease?

We are now recruiting for the next phase of research on an experimental vaccine therapy to treat Coeliac Disease.

Currently, the only way to manage the disease is by the lifelong and strict avoidance of gluten in the diet, as even small amounts of gluten can cause gastrointestinal damage and related symptoms. A gluten-free diet is exceptionally demanding for patients, expensive, and can be difficult to maintain as gluten is used extensively in modern food production.

Our study will explore whether the use of a novel vaccine therapy can switch off the immune response and restore gluten tolerance.

We are currently recruiting study participants who:

  • Are between the ages of 18 and 70.
  • Have been on a gluten free diet for at least 12 months.
  • Have been medically diagnosed with Coeliac Disease, by biopsy.
  • Are willing to attend approximately 20 clinic visits over a 6 month period.

To see if you are eligible complete the questionnaire below, or call the Clinical Trials Centre on 07 5456 3797.

Full title: A Phase 2, Randomised, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults with Coeliac Disease to Assess the Effect of Nexvax2 on Symptoms after Masked Gluten Food Challenge.

Ethics Approval: Bellberry Human Research Ethics Committee

 

If you experience difficulty completing the survey please email trials@usc.edu.au

Start Questionnaire?
We can only accept submissions from Australian residents. Please confirm you reside in Australia.
Are you 18 to 70 years old?
Have you been medically diagnosed with Coeliac Disease?
Have you had a small bowel biopsy to confirm the diagnosis?
Have you been following a strict gluten-free diet for at least the last 12 months?
Would you be willing to consume a moderate amount of gluten equivalent to approximately 2 slices of wheat bread?
Do you have a history of inflammatory bowel disease and/or microscopic colitis?
Are you currently using immunomodulatory or immunosuppressing medications, or have you used these in the last 6 months? Examples include methotrexate and azathioprine.
Have you participated in a previous Nexvax2 study, and been given study medication or placebo?
Are you presently pregnant or breast feeding, or intending to become pregnant in the next 6 months?
Are you willing to use an effective method of contraception for the duration of the trial?
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