TCRγδ+ Cells After Gluten-free Diet: A Biomarker for Coeliac Disease?

CompletedOBSERVATIONAL
Enrollment

116

Participants

Timeline

Start Date

January 1, 2013

Primary Completion Date

December 1, 2020

Study Completion Date

December 31, 2020

Conditions
Celiac Disease
Interventions
DIAGNOSTIC_TEST

Endoscopic procedure with duodenal biopsy

"* In all patients the investigators will analyse coeliac serology, DQ-genotype, and results of two duodenal biopsy sampling (one at diagnosis before starting the GFD and another sampling during follow-up with GFD) for assessment of both histopathology and intraepithelial lymphocyte subpopulations by T-cell flow cytometry. In addition, clinical, serological, and histological response to GFD will be evaluated.~* T-cell flow cytometry assay is performed as previously described by our group in previous studies. In all patients, an additional duodenal biopsy sample is taken from the second-third portion of the duodenum at the same endoscopic procedure that for histopathology. The normal cut-off values for the IEL cytometric pattern in our laboratory are CD3+TCRγδ+ IEL ≤8.5% (≤mean + 2SD) and CD3- IEL ≥10% (10th percentile). The cut-offs define four intraepithelial lymphogram patterns: normal, isolated decrease in CD3- cells, isolated increase in TCRγδ+ cells, and the coeliac lymphogram."

Trial Locations (1)

08221

Hospital Universitari Mutua Terrassa, Terrassa

All Listed Sponsors
lead

Hospital Mutua de Terrassa

OTHER

NCT05733663 - TCRγδ+ Cells After Gluten-free Diet: A Biomarker for Coeliac Disease? | Biotech Hunter | Biotech Hunter