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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospital Mutua de Terrassa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals under diagnostic evaluation for celiac disease

Disqualifiers

Failure to sign informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Patients with suspected celiac disease

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Mutua de Terrassa

Lead sponsor

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