Clinical Trial

Histomolecular Profiling in Small-Bowel Diseases

Study acronym: Deep Bowel
Recruiting
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Summary
This prospective cohort study aims to establish reliable histological reference values for normal small-bowel mucosa, improve histological diagnostic quality in celiac disease, and develop an advanced molecular profile for disease diagnosis and treatment response evaluation. The study will collect duodenal biopsies from three groups: healthy controls undergoing clinically indicated gastroscopy, patients referred for primary celiac disease diagnostics, and patients with small-bowel mucosal injury unresponsive to a gluten-free diet. Patients will undergo routine clinical assessment via standard pathology review of diagnostic biopsies. Biopsies will be analyzed using digital morphometry, AI-based image analysis, RNA sequencing (transcriptomics), and intestinal organoid cultures.
Trial Details
NCT Number NCT07556328
Lead Sponsor Tampere University Hospital
Collaborators: Tampere University
Conditions Celiac Disease, Small Bowel Disease, Refractory Celiac Disease
Enrollment 300 participants
Start Date 2025-11-01
Primary Completion 2035-12-31 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-29