Coral Sea Clinical Research Institute

 
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Join our trial

The Coral Sea Clinical Research Institute, in conjunction with ImmusanT, are conducting trial research into an experimental vaccine therapy to treat Coeliac Disease. We are seeking those with biopsy proven Coeliac Disease to participate in the trial.

 

Who we're looking for:

If you’re an adult, aged 18 to 70 years, who has biopsy proven Coeliac Disease and have been following a gluten-free diet for at least 12 months, we’d love you to apply! As part of the screening process, we will test to see if you are positive for one of the genes which is linked to Coeliac Disease. During the trial, we’ll ask you to consume a small amount of gluten at certain time-points, so we need to make sure that you are willing to do this and to follow the necessary steps of the trial.

During the trial we'll ask you to:

Complete twice-weekly injections, some of which you will be expected to self-administer, during the treatment phase and to intermittently give blood samples. We will also monitor your vital signs, via blood pressure and pulse. You’ll need to complete questionnaires and complete a daily electronic diary. You may also be offered the opportunity to undertake a gastroscopy and biopsy.

How long does the trial go for?

The trial consists of a screening period of six weeks, an approximately 16-week treatment period, and a four-week post-treatment follow-up period.

Is this trial right for you?

You may be asked to perform self-injections, so if you are uncomfortable with this, you may not be suitable for the trial. For this trial, we’re looking for people with biopsy proven Coeliac Disease who have been on a gluten free diet for at least 12 months. To be eligible for the study you must be positive for a specific gene. This genetic test will be part of the screening visit. There also will be some conditions (e.g. if you also had inflammatory bowel disease), which would exclude you from being involved in the trial. We also cannot accept patients who are lactating or pregnant


Ok, I’m ready to join the trial!

If you’ve read through the details above and are ready to join our trial, please complete the registration form below and we’ll be in contact with you shortly.

 

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