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New Coeliac Disease Clinical Trial

Potential Treatment for Coeliac Disease

💡  Help researchers learn more about a new potential therapy for Coeliac Disease.

💡 Qualify to take part and you could receive study-related care at no cost, as well as compensation.

Click here or scroll down to learn about this study's inclusion criteria ⬇️

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If you take part in the research study you will receive:

Reimbursement of costs

For out-of-pocket expenses, such as travel and parking.

Free study-related medical care

You may gain access to new potential treatments, before they are widely available.

No overnight stays!

9 study site visits that are out-patient only.

Do your part to help advance breakthroughs in clinical research.

🏥 Study Guide

Who can take part in this study?

In order to be eligible to participate in the study, you must meet all of the following:

  • You are aged 18 - 65 years old
  • You have been clinically diagnosed with Coeliac Disease (biopsy proven) for at least 12 months prior to taking part in the study
  • You have successfully maintained a gluten-free diet for at least the past 12 months.

Who is unable to take part in this study?

Unfortunately, if you meet any of the following, this study is not the right fit for you:

  • Anyone who has a gluten or wheat allergy separate from Coeliac Disease
  • Anyone with a history of other clinically significant diseases of the intestinal tract

How long will the study take?

If you agree to take part, and the study is suitable for you, your participation in the study is expected to last up to 84 days. This includes:

  • Screening period of up to 28 days (involving 2 visits to the study site)
  • Treatment period of 28 days (daily dosing and 6 visits to the study site on Day 1, 8, 14, 15, 22, and 29).
  • 15-day gluten challenge period
  • Day 14 (the first day of the gluten challenge) will be a full day of monitoring at the site (no overnight stay required) and Day 17 will be a telephone call for a wellness check
  • Follow-up period lasting 28 days (involving 1 visit to the study site on Day 56)

What is the purpose of this study?

The research project is testing a potential new treatment for coeliac disease – a chronic digestive autoimmune disorder that damages the small intestine. There are currently no approved medications for Coeliac Disease. The only treatment option available for people suffering with this disease is a strict gluten-free diet. Even then, symptoms of Coeliac Disease still persist in many patients, even when adhering to this treatment strategy. The aim of this trial is to investigate the efficacy of a drug therapy with the potential of improving both the quality of life and long-term health outcomes of people living with Coeliac Disease.

What is Coeliac Disease?

Coeliac disease is an autoimmune disease where the lining of the small intestine is damaged by tiny amounts of gluten. If you suffer from coeliac disease, your immune system’s response to gluten causes damage to the small intestine where the tiny, finger-like projections lining the bowel, called villi, become inflamed and flattened. This reduces the body’s ability to absorb nutrients from food.

Some common symptoms of Coeliac Disease include:

  • Gastrointestinal symptoms (e.g. diarrhoea, constipation, nausea, vomiting, etc.)
  • Iron deficiency or anaemia
  • Fatigue
  • Weight loss

This disease cannot be cured, although it can be effectively managed with a strict, lifelong gluten-free diet.

Where is my nearest study site?

Here is a list of all of the sites who are currently recruiting for this study:

  • NZ, Auckland, Grafton (Optimal Clinical Trials)
  • NZ, Hawke's Bay (P3 Research Hawke's Bay)
  • NZ, Palmerston North (P3 Research Palmerston North)

 

What if I have other questions about the study?

We are here for you! Click or tap this button to send an email to our Patient Experience team: