Celiac DiseaseNATURCELNCT07070596
Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Celiac Disease
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 1 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Individuals under diagnostic evaluation for celiac disease
Who cannot join
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, 08221
About this study
Official title: NATURCEL Registry: Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies
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
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected celiac disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with confirmed celiac disease diagnosis based on serologic and histologic criteria among those with suspected celiac disease
Measured: End of diagnostic evaluation (up to 10 weeks after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd), Hospital Universitari de Bellvitge, Hospital Clinic of Barcelona, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Hospital Arnau de Vilanova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070596
- Sponsor's protocol ID
- P/25-076
- Acronym
- NATURCEL
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NATURCEL Registry: Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-celiac Enteropathies
- ClinicalTrials.gov ID
- NCT07070596
- Acronym / sponsor ID
- NATURCEL / P/25-076
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd), Hospital Universitari de Bellvitge, Hospital Clinic of Barcelona, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Hospital Arnau de Vilanova
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected celiac disease | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Individuals under diagnostic evaluation for celiac disease
Key exclusion criteria (1 listed)
- Failure to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albert Martín-Cardona, MD ((0034)937365050, malaltiaceliaca@mutuaterrassa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.