Histology and molecular profiling of small-bowel biopsies to improve celiac care
Histological and Molecular Profiling in the Diagnostics and Treatment of Small-Bowel Diseases - A Prospective Cohort Study (The DeepBowel Study)
This project will test whether digital imaging, AI, gene-level profiling, and lab-grown intestinal cells can help diagnose and understand celiac disease and related small-bowel problems in adults having a gastroscopy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 3 sites (Tampere and 2 other locations) |
| Trial ID | NCT07556328 on ClinicalTrials.gov |
What this trial studies
This prospective cohort collects duodenal biopsies from three adult groups: healthy controls undergoing clinically indicated gastroscopy with negative celiac antibodies, people referred for primary celiac diagnostics, and patients with persistent small-bowel mucosal injury despite a gluten‑free diet. Biopsies will be digitized for AI-based morphometry to establish reference villus-to-crypt ratios and reduce observer variability. Samples will also undergo RNA sequencing to profile molecular pathways and comparison with drug-trial datasets, and intestinal organoids will be grown to model disease progression and refractory injury. Research samples will be pseudonymized and processed at the Tampere University Celiac Disease Research Center, with statistical analyses performed in collaboration with the study statistician.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for a clinically indicated gastroscopy, including those referred for primary celiac diagnostics, healthy controls with negative celiac antibodies, and patients with small‑bowel mucosal injury not responding to a gluten‑free diet, are the intended participants.
Not a fit: People who are under 18, unable to provide informed consent, have other small‑bowel diseases causing mucosal injury (for healthy control enrollment), or are not undergoing endoscopy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could make biopsy readings more accurate and provide molecular markers to guide diagnosis and treatment decisions for celiac and refractory small-bowel disease.
How similar studies have performed: AI and digital morphometry have shown promise in improving histology reproducibility in related work, while combining transcriptomics and organoid modeling in celiac disease is relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Tampere and 2 other locations
- Hatanpää Specialist Medical Care — Tampere, Finland (Recruiting)
- Tampere University Hospital (Tays) — Tampere, Finland (Recruiting)
- Valkeakoski Regional Hospital — Valkeakoski, Finland (Recruiting)
Study contacts
- Study coordinator: Juha Taavela
- Email: juha.taavela@tuni.fi
- Phone: +358443400330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.