Gluten Threshold Study

Patients with coeliac disease can experience acute food poisoning symptoms related to an immune activation phenomenon within two hours after ingesting just 5-10 grams of wheat gluten. 

 Currently in Australia and New Zealand, the uncertainty over the safe dose of gluten has led to a ‘no detectable’ gluten standard for food labelled ‘gluten free’. However, throughout the rest of the world the ‘gluten free’ standard is 20 parts per million (which is higher than ‘no detectable’). 

Currently, we do not know the minimum dose of gluten that activates an immune response, injures the gut and causes symptoms. This has in turn taken a toll on food safety standards in Australia and worldwide. 

 Dr James Daveson is addressing this knowledge gap through the Gluten Threshold Study. This study will compare small doses of gluten; Each participant is allocated either a dose of gluten or a placebo (which contains no gluten at all) through a process known as 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 determine if there is a minimum threshold or a ‘safe dose’ for the amount of gluten ingested by Coeliac Disease patients. Other potential outcomes of this study include: 

• Non-invasive diagnostic test could be developed for ‘at-risk’ relatives 
• Improved symptom changes for patients 
• Identify biomarkers for Coeliac Disease onset 

Results

The impacts of this study are aimed at reducing gluten induced intestinal injury, by understanding the amount of gluten that will induce an immune response. Our results so far have conclusively shown a requirement for updating FDA and EPA regulations around “GF” labelling and further results will enhance and strengthen programs being developed for the advancement of greater food security for the coeliac community. To hear more about these results, please register your interest using the form below.  

Recruitment

This clinical trial has been split into 4 cohorts: 

Cohort 1: 6 patients of high-dose gluten challenge, was completed in November 2022
Cohort 2: 15 patients administered with decreasing amounts of gluten as per the Fibonacci scaling, was completed in May 2023.
Cohort 3: 15 patients administered with decreasing amounts of gluten as per the Fibonacci scaling lower than that of Cohort 2, was completed in November 2023.
Cohort 4: Recruitment for a total of 15 participants is currently open for this cohort and we will be administering doses lower than the minimum established by the FDA and EPA. We expect to begin dosing new participants in February 2024 with completion of study in May 2024.