Actively Recruiting
Histomolecular Profiling in Small-Bowel Diseases
Led by Tampere University Hospital · Updated on 2026-04-29
300
Participants Needed
3
Research Sites
530 weeks
Total Duration
On this page
Sponsors
T
Tampere University Hospital
Lead Sponsor
T
Tampere University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Histomolecular Profiling in Small-Bowel Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing clinically indicated upper gastrointestinal endoscopy (gastroscopy)
- Provided written informed consent before the procedure
- For healthy controls: Negative celiac disease antibodies and no suspected celiac disease
- For celiac diagnostics group: Referred for primary celiac disease diagnostics requiring duodenal biopsy
- For refractory injury group: Confirmed small-bowel mucosal injury not improving with a gluten-free diet
You will not qualify if you...
- For healthy controls: Presence of other small-bowel diseases causing mucosal injury such as Crohn's disease or small-bowel ulcers
- Inability to provide written informed consent
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hatanpää Specialist Medical Care
Tampere, Finland, 33720
Actively Recruiting
2
Tampere University Hospital (Tays)
Tampere, Finland, 33720
Actively Recruiting
3
Valkeakoski Regional Hospital
Valkeakoski, Finland, 33720
Actively Recruiting
Research Team
J
Juha Taavela
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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