Coeliac Disease – Gluten Threshold Study

Coeliac Disease – Gluten Threshold Study

About this clinical trial

Currently, we do not know the minimum dose of gluten that activates an immune response, injures the gut and causes symptoms. To find out, we need to compare different doses of gluten.  Each participant is allocated a dose of gluten or a placebo (which contains no gluten at all) by chance (this is called randomisation).  The dose of gluten/placebo will be administered in a “gluten challenge”, which means that participants will ingest the gluten/placebo and then be observed for side effects.

This study aims to define the minimum amount of gluten that activates the immune response to gluten, injures the gut and causes symptoms in patients with coeliac disease.

Patients Required

Estimated completion

December 2022

Total participants required


Study location

The Wesley Hospital

Trial title

Gluten Threshold Study – A Double-Blind, Placebo-Controlled, Adaptive Dose-Response Study To Assess the Acute Effects of Gluten in Adults with Treated Coeliac Disease


Inclusion Criteria:

  1. Adults 25 to 75 years of age (inclusive)
  2. A history of Coeliac disease diagnosed on the basis of duodenal biopsy showing villous atrophy and abnormal coeliac disease-specific serology.
  3. Initiated gluten-free diet at least 2 years prior to screening.

Additional information

You can find out more about the Gluten Threshold Study by visiting the ANZCTR website.

Lead investigator

A/Prof James Daveson

If you would like more information about this clinical trial, please complete the Coeliac Disease Gluten Threshold contact form


Wesley Medical Research

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