NCT05786183

Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Diagnostic Accuracy of a Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies to Enable a Real Time Diagnosis of Celiac Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 163 (estimated)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 1 Year – 22 Years
• Healthy volunteers: Not accepted

Summary

Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).

Conditions

• Coeliac Disease

Timeline

• Start date: 2020-02-15
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2023-03-27
• Last updated: 2023-03-27

Locations

1 site across 1 country: Italy