Validation of a New Innovative Method for Specific Marker Detection in Celiac Disease

Launched by IRCCS BURLO GAROFOLO · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new, simpler method to detect markers of celiac disease (CD) in children. Celiac disease is an autoimmune condition that affects how the body reacts to gluten, a protein found in wheat, barley, and rye. In many cases, diagnosing CD can be challenging, especially when patients show only mild signs or fluctuating test results. This trial aims to replace a complex laboratory test with a quicker and more straightforward test that can be done right in the doctor's office. The new test will help identify specific antibodies linked to celiac disease more rapidly, which could lead to faster diagnoses and earlier treatment with a gluten-free diet.

To participate in this trial, children aged 2 to 18 who are scheduled for an endoscopy (a procedure where a thin tube is used to look inside the digestive tract) due to suspected celiac disease or other digestive conditions may be eligible. Participants will undergo routine procedures, and their samples will be tested using the new method, which takes about 15 minutes. This study is currently recruiting participants, and it’s important to note that those with certain bleeding disorders or already diagnosed with celiac disease based on the latest guidelines are not eligible to join. By taking part, families can contribute to the development of better diagnostic tools for celiac disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Patients undergoing an elective esophagogastroduodenoscopy (EGD) for suspected Celiac Disease (CD), eosinophilic esophagitis, autoimmune enteropathy, inflammatory bowel disease, gastritis, gastric or duodenal ulcer, gastroesophageal reflux disease.
• Exclusion Criteria:
• • Bleeding disorders
• • Patients fulfilling the new European Society for Paediatric Gastroenterology Hepatology and Nutrition (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