Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

IRCCS Burlo Garofolo

Status: Enrolling

Conditions: Coeliac Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05786183

RC 34/20

Details and patient eligibility

About

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).

Enrollment: 163 estimated patients

Sex: All

Ages: 1 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected CD, eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.

Exclusion criteria

• Bleeding disorders
• Patients fulfilling the new ESPGHAN Guidelines for diagnosing CD (version 2020), for a serology based CD diagnosis
• Subjects in whom intestinal biopsies are not indicated as part of the diagnostic process.