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Histomolecular Profiling in Small-Bowel Diseases

NCT07556328 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-29

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2035-12-31
Completion
2035-12-31

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556328 on ClinicalTrials.gov