Celiac DiseaseHNCELNCT05968404
A Population-based Study of Celiac Disease in South Europe in Children Between 1 to 5 Years of Age
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa.
Trial summary
Celiac disease (CD) was diagnosed for years almost exclusively in children. This is due to the fact that in adulthood it manifests in a much more attenuated form, while the classic form with severe diarrhea, malnutrition and dehydration is observed almost exclusively in children. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- How many people
- 3,659 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients from ambulatory minor surgery departments (= general population sample). Regarding age and sex, inclusion is done reproducing the reference population of the area.
Who may be able to join
None listed.
Who cannot join
- Heart failure or unstable cardiopathy
- COPD or respiratory insufficiency
- Coagulopathy
- Hepatic cirrhosis
- Kidney failure
- Active neoplasm
- Gluten-free diet without CD diagnosis
About this study
Official title: A Population-based Study of Pediatric Celiac Disease in South Europe
Celiac disease (CD) was diagnosed for years almost exclusively in children. This is due to the fact that in adulthood it manifests in a much more attenuated form, while the classic form with severe diarrhea, malnutrition and dehydration is observed almost exclusively in children. Classic studies, carried out prior to the widespread use of serology as a CD diagnostic tool, already showed that there is variability in gluten sensitivity and that in a non-negligible proportion of cases (10%) gluten sensitivity appears to be transient. Subsequent studies, including patients diagnosed by serology or population screening studies, suggest that progression to gluten latency or tolerance may occur in a higher proportion of patients, ranging from 20 to 50% depending on the geographical region.
In the first decade of the 2000s, the researchers group performed a prevalence observational cross-sectional study survey in Catalonia (autonomous region in the northeast of Spain) that accurately reflected the distribution of the reference Catalan population in terms of sex and age. The results showed a drastic and significant drop in the prevalence of CD disease in relation to age, with the prevalence of CD in children being 5 times higher than adults (1:71 vs. 1:357). Strikingly, the reduction in prevalence was especially notable in the first 4 years of life.
Read more
Two possibilities were proposed to explain this unexpected finding in a disease that is lifelong: 1) The existence of an environmental effect (cohort effect) acting as a disease trigger in early childhood during the study period (e.g., bacterial or viral infections, vaccines, food policies related to gluten introduction, use of antibiotics, etc.). 2) The appearance of age-related tolerance to gluten in a proportion of cases. Interestingly, it has been suggested that immunological tolerance might be more frequent in children diagnosed with CD before the age of two.
The aims of the present epidemiological study are: 1) to determine the prevalence of CD in Catalonia in children under 5 years of age and compare it with the results obtained in the previous 2004-2007 study; 2) to investigate the potential effect of environmental factors on disease prevalence; and 3) to evaluate longitudinally the appearance of tolerance to gluten in the CD cases detected. Therefore, this study has been designed using exactly the same CD screening methodology and reproducing the reference population in the same geographical area as the previous 2004-2007 study.
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, environmental factors, tolerance to gluten
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
CD prevalence
CD cases detection via tissue transglutaminase IgA antibodies (tTGA)(serological CD marker) in blood serum
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2013
- Primary completion31 Dec 2019
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 3,659 participants (actual)
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 Sant Joan de Deu, Institut Català d'Oncologia, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge, Catlab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968404
- Sponsor's protocol ID
- P13001
- Acronym
- HNCEL
- Status last verified
- Jul 2023
- First submitted
- 21 Jul 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vivas S, Ruiz de Morales JM, Fernandez M, Hernando M, Herrero B, Casqueiro J, Gutierrez S. Age-related clinical, serological, and histopathological features of celiac disease. Am J Gastroenterol. 2008 Sep;103(9):2360-5; quiz 2366. doi: 10.1111/j.1572-0241.2008.01977.x. Epub 2008 Aug 12.
PubMed 18702652Ansaldi N, Tavassoli K, Faussone D, Forni M, Oderda G. [Clinico-histological behavior of celiac patients after gluten load following the definitive diagnosis]. Pediatr Med Chir. 1988 Jan-Feb;10(1):3-6. Italian.
PubMed 3375125Matysiak-Budnik T, Malamut G, de Serre NP, Grosdidier E, Seguier S, Brousse N, Caillat-Zucman S, Cerf-Bensussan N, Schmitz J, Cellier C. Long-term follow-up of 61 coeliac patients diagnosed in childhood: evolution toward latency is possible on a normal diet. Gut. 2007 Oct;56(10):1379-86. doi: 10.1136/gut.2006.100511. Epub 2007 Feb 15.
PubMed 17303598Marine M, Farre C, Alsina M, Vilar P, Cortijo M, Salas A, Fernandez-Banares F, Rosinach M, Santaolalla R, Loras C, Marques T, Cusi V, Hernandez MI, Carrasco A, Ribes J, Viver JM, Esteve M. The prevalence of coeliac disease is significantly higher in children compared with adults. Aliment Pharmacol Ther. 2011 Feb;33(4):477-86. doi: 10.1111/j.1365-2036.2010.04543.x. Epub 2010 Dec 19.
PubMed 21166832
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Study of Pediatric Celiac Disease in South Europe
- ClinicalTrials.gov ID
- NCT05968404
- Acronym / sponsor ID
- HNCEL / P13001
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, environmental factors, tolerance to gluten
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,659 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd), Hospital Sant Joan de Deu, Institut Català d'Oncologia, University of Barcelona, Institut d'Investigació Biomèdica de Bellvitge, Catlab
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Aug 2023 (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 (CD) was diagnosed for years almost exclusively in children. This is due to the fact that in adulthood it manifests in a much more attenuated form, while the classic form with severe diarrhea, malnutrition and dehydration is observed almost exclusively in children. Classic studies, carried out prior to the widespread use of serology as a CD diagnostic tool, already showed that there is variability in gluten sensitivity and that in a non-negligible proportion of cases (10%) gluten sensitivity appears to be transient. Subsequent studies, including patients diagnosed by serology or population screening studies, suggest that progression to gluten latency or tolerance may occur in a higher proportion of patients, ranging from 20 to 50% depending on the geographical region.
In the first decade of the 2000s, the researchers group performed a prevalence observational cross-sectional study survey in Catalonia (autonomous region in the northeast of Spain) that accurately reflected the distribution of the reference Catalan population in terms of sex and age. The results showed a drastic and significant drop in the prevalence of CD disease in relation to age, with the prevalence of CD in children being 5 times higher than adults (1:71 vs. 1:357). Strikingly, the reduction in prevalence was especially notable in the first 4 years of life.
Two possibilities were proposed to explain this unexpected finding in a disease that is lifelong: 1) The existence of an environmental effect (cohort effect) acting as a disease trigger in early childhood during the study period (e.g., bacterial or viral infections, vaccines, food policies related to gluten introduction, use of antibiotics, etc.). 2) The appearance of age-related tolerance to gluten in a proportion of cases. Interestingly, it has been suggested that immunological tolerance might be more frequent in children diagnosed with CD before the age of two.
The aims of the present epidemiological study are: 1) to determine the prevalence of CD in Catalonia in children under 5 years of age and compare it with the results obtained in the previous 2004-2007 study; 2) to investigate the potential effect of environmental factors on disease prevalence; and 3) to evaluate longitudinally the appearance of tolerance to gluten in the CD cases detected. Therefore, this study has been designed using exactly the same CD screening methodology and reproducing the reference population in the same geographical area as the previous 2004-2007 study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients from ambulatory minor surgery departments (= general population sample). Regarding age and sex, inclusion is done reproducing the reference population of the area.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Heart failure or unstable cardiopathy
- COPD or respiratory insufficiency
- Coagulopathy
- Hepatic cirrhosis
- Kidney failure
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
CD prevalence
Time frame: at inclusion
CD cases detection via tissue transglutaminase IgA antibodies (tTGA)(serological CD marker) in blood serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Background: PubMed 18702652Vivas S, Ruiz de Morales JM, Fernandez M, Hernando M, Herrero B, Casqueiro J, Gutierrez S. Age-related clinical, serological, and histopathological features of celiac disease. Am J Gastroenterol. 2008 Sep;103(9):2360-5; quiz 2366. doi: 10.1111/j.1572-0241.2008.01977.x. Epub 2008 Aug 12.
- Background: PubMed 3375125Ansaldi N, Tavassoli K, Faussone D, Forni M, Oderda G. [Clinico-histological behavior of celiac patients after gluten load following the definitive diagnosis]. Pediatr Med Chir. 1988 Jan-Feb;10(1):3-6. Italian.
- Background: PubMed 17303598Matysiak-Budnik T, Malamut G, de Serre NP, Grosdidier E, Seguier S, Brousse N, Caillat-Zucman S, Cerf-Bensussan N, Schmitz J, Cellier C. Long-term follow-up of 61 coeliac patients diagnosed in childhood: evolution toward latency is possible on a normal diet. Gut. 2007 Oct;56(10):1379-86. doi: 10.1136/gut.2006.100511. Epub 2007 Feb 15.
- Background: PubMed 21166832Marine M, Farre C, Alsina M, Vilar P, Cortijo M, Salas A, Fernandez-Banares F, Rosinach M, Santaolalla R, Loras C, Marques T, Cusi V, Hernandez MI, Carrasco A, Ribes J, Viver JM, Esteve M. The prevalence of coeliac disease is significantly higher in children compared with adults. Aliment Pharmacol Ther. 2011 Feb;33(4):477-86. doi: 10.1111/j.1365-2036.2010.04543.x. Epub 2010 Dec 19.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa.
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 0 inclusion and 7 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: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD prevalence (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968404, which also lists 4 linked publications.
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 5 Sep 2023.