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
This trial accepts healthy volunteersQualifiers
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 population
Healthy, seropositive patients and refractory to treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: Group 1 - Healthy Controls (n = 130)
Group B: Group 2 - Celiac Disease Diagnostic Group (n = 130)
Group C: Group 3 - Refractory Small-Bowel Injury Group (n = 40)
Trial outcomes
Primary outcomes
1
Villus-to-crypt ratio
Villus-to-crypt ratio in normal duodenal mucosa established by digital morphometry
Time frame
Research biopsy obtained at time of endoscopy; digital morphometry performed through study completion (up to December 31, 2025)2
Transcriptomic
Transcriptomic (RNA-Seq) profile of duodenal mucosa in celiac disease patients and healthy controls
Time frame
Research biopsy obtained at time of endoscopy; RNA-Seq analysis performed through study completion (up to December 31, 2025)Secondary outcomes
1
AI/machine-learning-based image analysis
Development and validation of an AI/machine-learning-based image analysis tool for grading small-bowel mucosal damage
Time frame
Throughout study period up to December 31, 20352
Organoid culture models of celiac
Organoid culture models of celiac and refractory small-bowel epithelial inflammatory responses at the cellular and molecular level
Time frame
Throughout study period up to December 31, 20353
Comparison of transcriptomic profiles
Comparison of transcriptomic profiles between this cohort and the reference drug-trial dataset
Time frame
Throughout study period up to December 31, 2035Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
Source ClinicalTrials.gov