Histomolecular Profiling in Small-Bowel Diseases
Recruiting now
Conditions studied: Celiac Disease, Small Bowel Disease, Refractory Celiac Disease
In brief
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 facts
- Study ID
- NCT07556328
- Run by
- Tampere University Hospital
- People needed
- 300
- Starts
- 2025-11-01
- Expected to finish
- 2035-12-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years
- Clinically indicated upper gastrointestinal endoscopy (gastroscopy)
- Written informed consent obtained prior to procedure
- For Group 1 (Healthy Controls): Negative celiac disease antibodies (anti-transglutaminase and/or anti-endomysium); no suspected celiac
- For Group 2 (Celiac Diagnostics): Referred for primary celiac disease diagnostics requiring duodenal biopsy
- For Group 3 (Refractory Injury): Confirmed small-bowel mucosal injury not responsive to a gluten-free diet
You may not qualify if…
- For Group 1 (Healthy Controls): Other small-bowel diseases causing mucosal injury, including Crohn's disease and small-bowel ulcers
- Inability to provide written informed consent
- Refusal to participate
Where it is running
- Hatanpää Specialist Medical Care — Tampere, Finland (enrolling)
- Tampere University Hospital (Tays) — Tampere, Finland (enrolling)
- Valkeakoski Regional Hospital — Valkeakoski, Finland (enrolling)
Full record on ClinicalTrials.gov
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