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RECRUITING
NCT07556328

Histomolecular Profiling in Small-Bowel Diseases

Sponsor: Tampere University Hospital

View on ClinicalTrials.gov

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.

Official title: Histological and Molecular Profiling in the Diagnostics and Treatment of Small-Bowel Diseases - A Prospective Cohort Study (The DeepBowel Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-11-01

Completion Date

2035-12-31

Last Updated

2026-04-29

Healthy Volunteers

Yes

Locations (3)

Hatanpää Specialist Medical Care

Tampere, Finland

Tampere University Hospital (Tays)

Tampere, Finland

Valkeakoski Regional Hospital

Valkeakoski, Finland