Study of Tissue and Molecular Analysis in Diagnosing and Treating Small-Bowel Diseases Including Celiac Disease

What this Trial Is About

Researchers are investigating small-bowel diseases, focusing on celiac disease and other conditions causing mucosal injury. This observational study aims to establish reliable histological reference values for the normal small-bowel mucosa, improve diagnostic accuracy, and develop advanced molecular profiles to evaluate disease progression and treatment responses. The study recognizes the current variability and error rates in histological evaluations and seeks to enhance diagnostic quality through modern techniques. Participants are divided into three groups healthy controls undergoing gastroscopy with no celiac disease suspicion and negative antibodies, patients referred for primary celiac disease diagnostics requiring duodenal biopsy, and patients with refractory small-bowel mucosal injury unresponsive to a gluten-free diet. Duodenal biopsies are collected and analyzed using digital morphometry, AI-based image analysis, RNA sequencing, and intestinal organoid cultures. These processes occur at the research center under secure data handling. During the study, participants undergo routine clinical assessments, including standard pathology reviews of their biopsies. Researchers measure villus-to-crypt ratios and perform transcriptomic analyses to understand molecular changes. Additional evaluations include AI-driven image analyses and organoid modeling throughout the study period. Data is stored securely for 15 years. The study may last until December 2035, with primary outcome measures assessed up to December 2025 and ongoing molecular analyses extending through the entire period.

Histomolecular Profiling in Small-Bowel Diseases