Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies

NCT07070596 | Recruiting DMC

• 1 other identifier: P/25-076
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Celiac disease is a chronic immune-mediated enteropathy triggered by gluten intake, which affects the small intestine in genetically susceptible subjects (HLA-DQ2 and/or HLA-DQ8). Affecting both children and adults, it is among the most common genetically determined disorders in Western countries. The disease is characterized by clinical manifestations (mainly digestive symptoms and signs of intestinal malabsorption), the presence of specific antibodies (tissue transglutaminase and endomysium) and enteropathy. Currently, the only treatment for celiac disease is a strict gluten-free diet for life. The main objective of the NATURCEL registry (Study of the NATURal history, epidemiological, clinical, diagnostic and therapeutic aspects of celiac disease and non-celiac enteropathies) is to collect a wide range of data (epidemiological, clinical, genetic, immunological, etc.) for scientific and translational purposes. The registry will include individuals diagnosed with celiac disease or other gluten-related disorders, as well as patients with non-celiac enteropathies evaluated for suspected celiac disease. In the future, the project also aims to establish a biobank-an organized repository of biological samples-to further support scientific and medical research in this field.

Conditions

Celiac Disease

Keywords

Gluten-Related Disorders; Gluten-Free Diet; HLA-DQ2; HLA-DQ8; Tissue Transglutaminase Antibodies; Anti-Endomysial Antibodies; Pediatric and Adult Celiac Disease; TCRγδ+ lymphocytes

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with confirmed celiac disease diagnosis based on serologic and histologic criteria among those with suspected celiac disease

  End of diagnostic evaluation (up to 10 weeks after inclusion)

Study Arms (1)

Patients with suspected celiac disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with celiac disease and other gluten-related disorders based on established diagnostic guidelines (2019 European Society for the Study of CD for Adults, the Paris Consensus Criteria for the Diagnosis of Seronegative CD, and the 2020 ESPGHAN Criteria for the Diagnosis of CD in Childhood) and individuals with non-celiac enteropathies who have been found in the diagnostic process of suspected celiac disease.

You may qualify if:

• Individuals under diagnostic evaluation for celiac disease

You may not qualify if:

• Failure to sign informed consent

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead
• Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd): collaborator
• Hospital Universitari de Bellvitge: collaborator
• Hospital Clinic of Barcelona: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Hospital Arnau de Vilanova: collaborator

Study Sites (1)

Hospital Universitari MútuaTerrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Albert Martín-Cardona, MD

CONTACT

(0034)937365050; malaltiaceliaca@mutuaterrassa.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 17, 2025

Record last verified: 2025-06

Locations

ES (1)