HNCEL: A Population-based Study of Celiac Disease in South Europe in Children Between 1 to 5 Years of Age

Sponsor
Hospital Mutua de Terrassa (Other)
Overall Status
Completed
CT.gov ID
NCT05968404
Collaborator
Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd) (Other), Hospital Sant Joan de Deu (Other), Institut Català d'Oncologia (Other), University of Barcelona (Other), Institut d'Investigació Biomèdica de Bellvitge (Other), Catlab (Other)
3,659
124.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3659 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Population-based Study of Pediatric Celiac Disease in South Europe
    Actual Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Jun 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. CD prevalence [at inclusion]

      CD cases detection via tissue transglutaminase IgA antibodies (tTGA)(serological CD marker) in blood serum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Exclusion Criteria:
    • Heart failure or unstable cardiopathy

    • COPD or respiratory insufficiency

    • Coagulopathy

    • Hepatic cirrhosis

    • Kidney failure

    • Active neoplasm

    • Gluten-free diet without CD diagnosis

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital Mutua de Terrassa
    • 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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hospital Mutua de Terrassa
    ClinicalTrials.gov Identifier:
    NCT05968404
    Other Study ID Numbers:
    • P13001
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital Mutua de Terrassa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2023