Neurological Deficits in patients with classic Coeliac Disease (CD)
Research type
Research Study
Full title
Neurological Deficits in patients with classic Coeliac Disease (CD): A follow up study
IRAS ID
258975
Contact name
Marios Hadjivassiliou
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
A 3-year prospective study opened in January 2011 (funded by Coeliac UK and BRET) , recruiting 100 patients with newly diagnosed Coeliac Disease (CD) presenting to the gastroenterologists, clinically assessing them for any neurological deficits as well as performing MR imaging of the brain and MR spectroscopy of the cerebellum. A subgroup of 50 patients from this cohort underwent repeat imaging at 1 year after starting a GFD. Patients also underwent baseline serological testing for all gluten-related antibodies (including TG6) as well as undergoing gastroscopy and duodenal biopsy to demonstrate evidence of gluten sensitive enteropathy (CD). The data from this study has been submitted for publication and is currently under review in a high impact journal.
This proposed follow up study intends to try and recruit as many as possible from the original 100 patients that participated in the original study (most patients remain under the care of Professor Sanders and the PI). The patients will undergo serological monitoring to inform the strictness of their GFD, undergo a full neurological examination with repeat MR imaging including MR spectroscopy of the cerebellum. The clinical and imaging findings will be analysed based on the serological status of each patient: strict GFD with elimination of all the antibodies, partial GFD as indicated by positive antibodies and not on diet. In addition the findings will be compared with the baseline clinical and imaging characteristics of the original study. The study will take place at the Royal Hallamshire Hospital, and each patient will have 2 study visits during the study period.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0670
Date of REC Opinion
18 Apr 2019
REC opinion
Favourable Opinion