Gluten Threshold Study
Are you Eligible?This study aims to determine if there is a minimum threshold or a ‘safe dose’ for the amount of gluten ingested by patients with Coeliac Disease.
Research Objectives
Status
Estimated completion
Total participants required
Study location
Study Type
About this clinical trial
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
The impact of this study will enhance and strengthen programs being developed which are aimed at reducing gluten induced symptoms and intestinal injury, by understanding the amount of gluten that is toxic.
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 of varying amounts of gluten) is currently underway with recruitment completed and an expected finish in early to mid-April 2023
- 13/15 participants have been pre-screened for Cohort 3 with an expected start of early May
Recruitment for Cohort 4 (15 patients) is expected to commence in mid-July and completion of study is expected to be by mid-November.
Eligibility
Do you meet the following criteria?
- Adults 25 to 75 years of age (inclusive)
- A history of Coeliac disease diagnosed on the basis of duodenal biopsy showing villous atrophy and abnormal coeliac disease-specific serology.
- Initiated gluten-free diet at least 2 years prior to screening.
- Are based within the Greater Brisbane region
Additional information
You can find out more about the Gluten Threshold Study by visiting the ANZCTR website.
Lead investigators
- A/Prof James Daveson
Technical title
A Double-Blind, Placebo-Controlled, Adaptive Dose-Response Study To Assess the Acute Effects of Gluten in Adults with Treated Coeliac Disease.
Register your interest
If you would like more information about this clinical trial, please complete the contact form below.