Histomolecular Profiling in Small-Bowel Diseases

Sponsor
Tampere University Hospital
Study ID
NCT07556328
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Group 1 - Healthy Controls (n = 130)
    Adults ≥18 years undergoing clinically indicated gastroscopy (e.g., reflux symptoms) with no suspicion of celiac disease and negative celiac antibodies (anti-transglutaminase and/or anti-endomysium).
  • Arm: Group 2 - Celiac Disease Diagnostic Group (n = 130)
    Adults referred for primary celiac disease diagnostics requiring duodenal biopsy, in accordance with standard care guidelines.
  • Arm: Group 3 - Refractory Small-Bowel Injury Group (n = 40)
    Adults with small-bowel mucosal injury (villous atrophy) that does not respond to a gluten-free diet, referred for endoscopy to exclude ongoing histological damage.

Primary Outcome Measure

Villus-to-crypt ratio [ Time Frame: Research biopsy obtained at time of endoscopy; digital morphometry performed through study completion (up to December 31, 2025) ]

Central Contacts

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