Histomolecular Profiling in Small-Bowel Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsSponsors and collaborators
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
Source ClinicalTrials.gov