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Rapid Technique for the Detection of Intestinal Anti-transglutaminase Antibodies

Recruiting
1 - 22 years of age
Both
Phase N/A

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Overview

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).

Eligibility

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.

Study details

Coeliac Disease

NCT05786183

IRCCS Burlo Garofolo

25 January 2024

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