Histology and molecular profiling of small-bowel biopsies to improve celiac care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.