xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968404</url>
    </required_header>
    <id_info>
      <org_study_id>P13001</org_study_id>
      <nct_id>NCT05968404</nct_id>
    </id_info>
    <brief_title>A Population-based Study of Celiac Disease in South Europe in Children Between 1 to 5 Years of Age</brief_title>
    <acronym>HNCEL</acronym>
    <official_title>A Population-based Study of Pediatric Celiac Disease in South Europe</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Mutua de Terrassa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Sant Joan de Deu</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut Català d'Oncologia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Barcelona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institut d'Investigació Biomèdica de Bellvitge</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Catlab</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hospital Mutua de Terrassa</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Celiac disease (CD) was diagnosed for years almost exclusively in children. This is due to&#xD;
        the fact that in adulthood it manifests in a much more attenuated form, while the classic&#xD;
        form with severe diarrhea, malnutrition and dehydration is observed almost exclusively in&#xD;
        children. Classic studies, carried out prior to the widespread use of serology as a CD&#xD;
        diagnostic tool, already showed that there is variability in gluten sensitivity and that in a&#xD;
        non-negligible proportion of cases (10%) gluten sensitivity appears to be transient.&#xD;
        Subsequent studies, including patients diagnosed by serology or population screening studies,&#xD;
        suggest that progression to gluten latency or tolerance may occur in a higher proportion of&#xD;
        patients, ranging from 20 to 50% depending on the geographical region.&#xD;
  &#xD;
        In the first decade of the 2000s, the researchers group performed a prevalence observational&#xD;
        cross-sectional study survey in Catalonia (autonomous region in the northeast of Spain) that&#xD;
        accurately reflected the distribution of the reference Catalan population in terms of sex and&#xD;
        age. The results showed a drastic and significant drop in the prevalence of CD disease in&#xD;
        relation to age, with the prevalence of CD in children being 5 times higher than adults (1:71&#xD;
        vs. 1:357). Strikingly, the reduction in prevalence was especially notable in the first 4&#xD;
        years of life.&#xD;
  &#xD;
        Two possibilities were proposed to explain this unexpected finding in a disease that is&#xD;
        lifelong: 1) The existence of an environmental effect (cohort effect) acting as a disease&#xD;
        trigger in early childhood during the study period (e.g., bacterial or viral infections,&#xD;
        vaccines, food policies related to gluten introduction, use of antibiotics, etc.). 2) The&#xD;
        appearance of age-related tolerance to gluten in a proportion of cases. Interestingly, it has&#xD;
        been suggested that immunological tolerance might be more frequent in children diagnosed with&#xD;
        CD before the age of two.&#xD;
  &#xD;
        The aims of the present epidemiological study are: 1) to determine the prevalence of CD in&#xD;
        Catalonia in children under 5 years of age and compare it with the results obtained in the&#xD;
        previous 2004-2007 study; 2) to investigate the potential effect of environmental factors on&#xD;
        disease prevalence; and 3) to evaluate longitudinally the appearance of tolerance to gluten&#xD;
        in the CD cases detected. Therefore, this study has been designed using exactly the same CD&#xD;
        screening methodology and reproducing the reference population in the same geographical area&#xD;
        as the previous 2004-2007 study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2013</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CD prevalence</measure>
      <time_frame>at inclusion</time_frame>
      <description>CD cases detection via tissue transglutaminase IgA antibodies (tTGA)(serological CD marker) in blood serum</description>
    </primary_outcome>
    <enrollment type="Actual">3659</enrollment>
    <condition>Celiac Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients from ambulatory minor surgery departments (= general population sample).&#xD;
          Regarding age and sex, inclusion is done reproducing the reference population of the area.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Exclusion Criteria:&#xD;
  &#xD;
            -  Heart failure or unstable cardiopathy&#xD;
  &#xD;
            -  COPD or respiratory insufficiency&#xD;
  &#xD;
            -  Coagulopathy&#xD;
  &#xD;
            -  Hepatic cirrhosis&#xD;
  &#xD;
            -  Kidney failure&#xD;
  &#xD;
            -  Active neoplasm&#xD;
  &#xD;
            -  Gluten-free diet without CD diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <reference>
      <citation>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.</citation>
      <PMID>18702652</PMID>
    </reference>
    <reference>
      <citation>Ansaldi 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.</citation>
      <PMID>3375125</PMID>
    </reference>
    <reference>
      <citation>Matysiak-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.</citation>
      <PMID>17303598</PMID>
    </reference>
    <reference>
      <citation>Marine 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.</citation>
      <PMID>21166832</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Celiac Disease</keyword>
    <keyword>environmental factors</keyword>
    <keyword>tolerance to gluten</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968404
  org study id: P13001
  nct id: NCT05968404
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Other
  measure: CD prevalence
  time frame: at inclusion
  description: CD cases detection via tissue transglutaminase IgA antibodies (tTGA)(serological CD marker) in blood serum
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 5 Years
  healthy volunteers: Accepts Healthy Volunteers
  citation: 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.
  PMID: 18702652
  citation: Ansaldi 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.
  PMID: 3375125
  citation: Matysiak-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.
  PMID: 17303598
  citation: Marine 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.
  PMID: 21166832
  responsible party type: Sponsor
  mesh term: Celiac Disease