Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07556328

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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