Assessing TG6 Antibodies for Clinical Practice
Research type
Research Study
Full title
Should TG6 antibody testing be used in the diagnosis and monitoring of patients with coeliac disease?
IRAS ID
346003
Contact name
Iain D Croall
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation trust
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
"Gluten sensitivity" refers to people who have an immune reaction after eating gluten, making anti-gluten antibodies in their blood which we can detect by blood testing. Coeliac disease is one kind of this.
People with gluten sensitivity often have some level of damage to their brains. This can be relatively mild (but still worrisome), or may be much more serious. In all these cases going on a strict gluten free diet slows or stops entirely further brain deterioration. As the brain cannot recover well from existing damage this means it's very important to identify everyone who's gluten sensitivity means their brain is at risk so they can start treatment.
TG6 testing is a new blood test that identifies if someone has TG6 antibodies in their blood (a gluten antibody). Research in neurology departments has so far strongly suggested that "having TG6" is a sign that a patient is at risk of brain damage from gluten. It is already implemented in routine medical care in Sheffield, but existing data is very focused on patients who already have neurological problems. We know much less about the importance of a positive TG6 test in a "typical" case of coeliac disease, i.e. someone diagnosed from the gastroenterology department without obvious neurological problems.
In this study we would find the fraction of these patients who make TG6, and then run longitudinal tests to determine if a positive TG6 test is a sign that a patient is more likely to develop neurological/psychological problems. We would also repeat some neuropsychological tests on patients from the neurology department who have already taken part in a previous study (so that we can see how the patients progress over time). Finally, to better understand these overall conditions we would perform "advanced" brain MRI scans to see how the brain is affected by TG6.
REC name
Wales REC 6
REC reference
24/WA/0367
Date of REC Opinion
17 Dec 2024
REC opinion
Favourable Opinion