<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/NCT02248545</url>
  </required_header>
  <id_info>
    <org_study_id>ACPM06</org_study_id>
    <nct_id>NCT02248545</nct_id>
  </id_info>
  <brief_title>Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients</brief_title>
  <official_title>Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Palermo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Palermo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,&#xD;
      barley, and rye) that primarily affects the small intestine in genetically predisposed&#xD;
      patients and resolves with exclusion of gluten from the diet. Patients with CD show&#xD;
      circulating autoantibodies (anti-transglutaminase, anti-tTG) and suffer from the destruction&#xD;
      of a specific tissue cell type (the enterocytes) by CD8+ T cells. Furthermore, other&#xD;
      autoimmune diseases have been reported in association to CD in 20-30% of the cases. In the&#xD;
      last few year, a new clinical entity emerged, which seems include patients who consider&#xD;
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though&#xD;
      they do not have CD or wheat allergy. This clinical condition has been named &quot;Non-Celiac&#xD;
      Gluten Sensitivity&quot; (6), but, in a recent paper, the investigators suggested the term&#xD;
      &quot;Non-Celiac Wheat Sensitivity&quot; (NCWS), since, to date, it is not known what component of&#xD;
      wheat really causes the symptoms. The doubt areas about the NCWS regard also its pathogenesis&#xD;
      as, despite some papers evidenced an intestinal immunologic activation, others excluded it.&#xD;
      To explore the presence of autoimmunity in NCWS, the investigators evaluated: a) the&#xD;
      frequency of autoimmune diseases and b) the frequency of serum anti-nuclear antibodies (ANA)&#xD;
      positivity in newly diagnosed NCWS, compared to CD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,&#xD;
      barley, and rye) that primarily affects the small intestine in genetically predisposed&#xD;
      patients and resolves with exclusion of gluten from the diet. Although CD is not surely&#xD;
      placed among the autoimmune diseases, patients with CD show circulating autoantibodies&#xD;
      (anti-transglutaminase, anti-tTG) and suffer from the destruction of a specific tissue cell&#xD;
      type (the enterocytes) by CD8+ T cells. Furthermore, other autoimmune diseases have been&#xD;
      reported in association to CD in 20-30% of the cases. In the last few year, a new clinical&#xD;
      entity emerged, which seems include patients who consider themselves to be suffering from&#xD;
      problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat&#xD;
      allergy. This clinical condition has been named &quot;Non-Celiac Gluten Sensitivity&quot; (6), but, in&#xD;
      a recent paper, the investigators suggested the term &quot;Non-Celiac Wheat Sensitivity&quot; (NCWS),&#xD;
      since, to date, it is not known what component of wheat really causes the symptoms. The doubt&#xD;
      areas about the NCWS regard also its pathogenesis as, despite some papers evidenced an&#xD;
      intestinal immunologic activation, others linked NCWS to the dietary FODMAPs (Fermentable&#xD;
      Oligo-di and Mono-saccharides, And Polyols) load, thus excluding an immunologic involvement&#xD;
      in the NCWS. To explore the presence of autoimmunity in NCWS, in the present study the&#xD;
      investigators evaluated: a) the frequency of autoimmune diseases and b) the frequency of&#xD;
      serum anti-nuclear antibodies (ANA) positivity in newly diagnosed NCWS and CD patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Organ- and non-organ specific autoantibodies</measure>
    <time_frame>At first visit</time_frame>
    <description>We evaluated, by ELISA and Immunofluorescence, organ- and non-organ specific autoantibodies, i.e. Anti-Nuclear Antibodies (ANA) IgG, anti double-strand (anti-ds) DNA IgG Antibodies, Anti-Mitochondrial Antibodies (AMA), Liver Kidney Microsome (LKM) IgG Antibodies, Anti-Smooth Muscle Antibodies (ASMA) IgG, anti-Sjogren's Syndrome antigen A (anti-SSA) IgG Antibodies, anti-Sjogren's Syndrome antigen B (anti-SSB) IgG Antibodies, anti-Smith (anti-Sm) IgG Antibodies, anti-ThyroPerOxidase (anti-TPO) IgG Antibodies, anti-ThyroGlobulin (anti-TG) IgG Antibodies, anti-Glutamic Acid Decarboxylase (anti-GAD) IgG Antobodies, and Islet Cell Antibodies (ICA) IgG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire for autoimmunity.</measure>
    <time_frame>At first visit</time_frame>
    <description>The presence of autoimmune disorders was evaluated by a structured questionnaire, with the assistance of ad hoc-trained personnel, and review of patient' clinical records. The presence of one of the following diseases was looked for in all subjects: connective tissue diseases, autoimmune endocrinological diseases, autoimmune hepatitis, primary biliary cirrhosis, epilepsy with cerebral calcification, unexplained cerebellar ataxia, alopecia, psoriasis, dermatitis herpetiform, atrophic autoimmune gastritis, and immune anemia, neutropenia, or thrombocytopenia. The hospital records of all patients diagnosed for an autoimmune disorder were thoroughly examined to verify whether the recognized diagnostic criteria for each disorder had been fulfilled, together with age at diagnosis of the diseases and treatment received.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Non-Celiac Wheat Sensitivity</condition>
  <arm_group>
    <arm_group_label>Non-celiac Wheat Sensitivity Patients</arm_group_label>
    <description>Consecutive adult patients with irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Celiac Disease Patients</arm_group_label>
    <description>Celiac disease adult patients, sex- and age-matched, diagnosed according to standard criteria, during the same study period, chosen at random and enrolled as first control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Irritable Bowel Syndrome Patients</arm_group_label>
    <description>Irritable Bowel Syndrome adult patients, sex- and age-matched, diagnosed according to Rome II criteria, and unrelated to NCWS or other food &quot;intolerance&quot;, during the same study period, chosen at random and enrolled as second control group.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study included consecutive adult patients with irritable bowel syndrome (IBS)-like&#xD;
        clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS,&#xD;
        referred at the Internal Medicine Department of the University Hospital of Palermo, Italy,&#xD;
        and at the Internal Medicine Department of the Hospital of Sciacca, Agrigento, Italy,&#xD;
        between July 2011 and July 2013.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To diagnose NCWS the recently proposed criteria were adopted. All the patients met the&#xD;
             following criteria&#xD;
&#xD;
          -  negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) IgA and IgG&#xD;
             antibodies&#xD;
&#xD;
          -  absence of intestinal villous atrophy&#xD;
&#xD;
          -  negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum&#xD;
             specific IgE detection)&#xD;
&#xD;
          -  resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's&#xD;
             milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms&#xD;
&#xD;
          -  symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As we&#xD;
             previously described in other studies, DBPC cow's milk protein challenge and other&#xD;
             &quot;open&quot; food challenges were performed too.&#xD;
&#xD;
          -  Additional inclusion criteria were:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  follow-up duration longer than six months after the initial diagnosis&#xD;
&#xD;
          -  at least two outpatient visits during the follow-up period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  positive EmA in the culture medium of the duodenal biopsies, also in the case of&#xD;
             normal villi/crypts ratio in the duodenal mucosa&#xD;
&#xD;
          -  self-exclusion of wheat from the diet and refusal to reintroduce it, before entering&#xD;
             the study&#xD;
&#xD;
          -  other &quot;organic&quot; gastrointestinal disorders&#xD;
&#xD;
          -  nervous system disease and/or major psychiatric disorder&#xD;
&#xD;
          -  physical impairment limiting physical activity&#xD;
&#xD;
          -  menopause&#xD;
&#xD;
          -  steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Carroccio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Internal Medicine Department of the Hospital of Sciacca (Agrigento)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Internal Medicine Department of the Hospital of Sciacca (Agrigento)</name>
      <address>
        <city>Sciacca</city>
        <state>Agrigento</state>
        <zip>92019</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Unit of the &quot;Civico&quot; Hospital of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine Department of the University Hospital of Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.</citation>
    <PMID>23609613</PMID>
  </results_reference>
  <results_reference>
    <citation>Sollid LM, Jabri B. Triggers and drivers of autoimmunity: lessons from coeliac disease. Nat Rev Immunol. 2013 Apr;13(4):294-302. doi: 10.1038/nri3407. Epub 2013 Mar 15.</citation>
    <PMID>23493116</PMID>
  </results_reference>
  <results_reference>
    <citation>Sategna Guidetti C, Solerio E, Scaglione N, Aimo G, Mengozzi G. Duration of gluten exposure in adult coeliac disease does not correlate with the risk for autoimmune disorders. Gut. 2001 Oct;49(4):502-5. doi: 10.1136/gut.49.4.502.</citation>
    <PMID>11559646</PMID>
  </results_reference>
  <results_reference>
    <citation>Biagi F, Pezzimenti D, Campanella J, Corazza GR. Gluten exposure and risk of autoimmune disorders. Gut. 2002 Jul;51(1):140-1. doi: 10.1136/gut.51.1.140-a. No abstract available.</citation>
    <PMID>12077109</PMID>
  </results_reference>
  <results_reference>
    <citation>Verdu EF, Armstrong D, Murray JA. Between celiac disease and irritable bowel syndrome: the &quot;no man's land&quot; of gluten sensitivity. Am J Gastroenterol. 2009 Jun;104(6):1587-94. doi: 10.1038/ajg.2009.188.</citation>
    <PMID>19455131</PMID>
  </results_reference>
  <results_reference>
    <citation>Catassi C, Bai JC, Bonaz B, Bouma G, Calabro A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vecsei A, Volta U, Zevallos V, Sapone A, Fasano A. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839.</citation>
    <PMID>24077239</PMID>
  </results_reference>
  <results_reference>
    <citation>Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.</citation>
    <PMID>24275240</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Palermo</investigator_affiliation>
    <investigator_full_name>Pasquale Mansueto</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Non-Celiac Wheat Sensitivity</keyword>
  <keyword>Autoimmune diseases</keyword>
  <keyword>Anti-nuclear antibodies</keyword>
  <keyword>Celiac disease</keyword>
  <keyword>Irritable bowel syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02248545
org study id: ACPM06
nct id: NCT02248545
lead sponsor: 
has dmc: No
Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,
      barley, and rye) that primarily affects the small intestine in genetically predisposed
      patients and resolves with exclusion of gluten from the diet. Patients with CD show
      circulating autoantibodies (anti-transglutaminase, anti-tTG) and suffer from the destruction
      of a specific tissue cell type (the enterocytes) by CD8+ T cells. Furthermore, other
      autoimmune diseases have been reported in association to CD in 20-30% of the cases. In the
      last few year, a new clinical entity emerged, which seems include patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have CD or wheat allergy. This clinical condition has been named "Non-Celiac
      Gluten Sensitivity" (6), but, in a recent paper, the investigators suggested the term
      "Non-Celiac Wheat Sensitivity" (NCWS), since, to date, it is not known what component of
      wheat really causes the symptoms. The doubt areas about the NCWS regard also its pathogenesis
      as, despite some papers evidenced an intestinal immunologic activation, others excluded it.
      To explore the presence of autoimmunity in NCWS, the investigators evaluated: a) the
      frequency of autoimmune diseases and b) the frequency of serum anti-nuclear antibodies (ANA)
      positivity in newly diagnosed NCWS, compared to CD patients.
Celiac disease (CD) is an immune-based reaction to dietary gluten (storage protein for wheat,
      barley, and rye) that primarily affects the small intestine in genetically predisposed
      patients and resolves with exclusion of gluten from the diet. Although CD is not surely
      placed among the autoimmune diseases, patients with CD show circulating autoantibodies
      (anti-transglutaminase, anti-tTG) and suffer from the destruction of a specific tissue cell
      type (the enterocytes) by CD8+ T cells. Furthermore, other autoimmune diseases have been
      reported in association to CD in 20-30% of the cases. In the last few year, a new clinical
      entity emerged, which seems include patients who consider themselves to be suffering from
      problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat
      allergy. This clinical condition has been named "Non-Celiac Gluten Sensitivity" (6), but, in
      a recent paper, the investigators suggested the term "Non-Celiac Wheat Sensitivity" (NCWS),
      since, to date, it is not known what component of wheat really causes the symptoms. The doubt
      areas about the NCWS regard also its pathogenesis as, despite some papers evidenced an
      intestinal immunologic activation, others linked NCWS to the dietary FODMAPs (Fermentable
      Oligo-di and Mono-saccharides, And Polyols) load, thus excluding an immunologic involvement
      in the NCWS. To explore the presence of autoimmunity in NCWS, in the present study the
      investigators evaluated: a) the frequency of autoimmune diseases and b) the frequency of
      serum anti-nuclear antibodies (ANA) positivity in newly diagnosed NCWS and CD patients.
observational model: Case-Control
time perspective: Retrospective
measure: Organ- and non-organ specific autoantibodies
time frame: At first visit
description: We evaluated, by ELISA and Immunofluorescence, organ- and non-organ specific autoantibodies, i.e. Anti-Nuclear Antibodies (ANA) IgG, anti double-strand (anti-ds) DNA IgG Antibodies, Anti-Mitochondrial Antibodies (AMA), Liver Kidney Microsome (LKM) IgG Antibodies, Anti-Smooth Muscle Antibodies (ASMA) IgG, anti-Sjogren's Syndrome antigen A (anti-SSA) IgG Antibodies, anti-Sjogren's Syndrome antigen B (anti-SSB) IgG Antibodies, anti-Smith (anti-Sm) IgG Antibodies, anti-ThyroPerOxidase (anti-TPO) IgG Antibodies, anti-ThyroGlobulin (anti-TG) IgG Antibodies, anti-Glutamic Acid Decarboxylase (anti-GAD) IgG Antobodies, and Islet Cell Antibodies (ICA) IgG.
measure: Questionnaire for autoimmunity.
time frame: At first visit
description: The presence of autoimmune disorders was evaluated by a structured questionnaire, with the assistance of ad hoc-trained personnel, and review of patient' clinical records. The presence of one of the following diseases was looked for in all subjects: connective tissue diseases, autoimmune endocrinological diseases, autoimmune hepatitis, primary biliary cirrhosis, epilepsy with cerebral calcification, unexplained cerebellar ataxia, alopecia, psoriasis, dermatitis herpetiform, atrophic autoimmune gastritis, and immune anemia, neutropenia, or thrombocytopenia. The hospital records of all patients diagnosed for an autoimmune disorder were thoroughly examined to verify whether the recognized diagnostic criteria for each disorder had been fulfilled, together with age at diagnosis of the diseases and treatment received.
arm group label: Non-celiac Wheat Sensitivity Patients
description: Consecutive adult patients with irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.
arm group label: Celiac Disease Patients
description: Celiac disease adult patients, sex- and age-matched, diagnosed according to standard criteria, during the same study period, chosen at random and enrolled as first control group.
arm group label: Irritable Bowel Syndrome Patients
description: Irritable Bowel Syndrome adult patients, sex- and age-matched, diagnosed according to Rome II criteria, and unrelated to NCWS or other food "intolerance", during the same study period, chosen at random and enrolled as second control group.
Blood samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Antonio Carroccio, MD, PhD
role: Principal Investigator
affiliation: Internal Medicine Department of the Hospital of Sciacca (Agrigento)
facility: 
facility: 
facility: 
country: Italy
citation: Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; American College of Gastroenterology. ACG clinical guidelines: diagnosis and management of celiac disease. Am J Gastroenterol. 2013 May;108(5):656-76; quiz 677. doi: 10.1038/ajg.2013.79. Epub 2013 Apr 23.
PMID: 23609613
citation: Sollid LM, Jabri B. Triggers and drivers of autoimmunity: lessons from coeliac disease. Nat Rev Immunol. 2013 Apr;13(4):294-302. doi: 10.1038/nri3407. Epub 2013 Mar 15.
PMID: 23493116
citation: Sategna Guidetti C, Solerio E, Scaglione N, Aimo G, Mengozzi G. Duration of gluten exposure in adult coeliac disease does not correlate with the risk for autoimmune disorders. Gut. 2001 Oct;49(4):502-5. doi: 10.1136/gut.49.4.502.
PMID: 11559646
citation: Biagi F, Pezzimenti D, Campanella J, Corazza GR. Gluten exposure and risk of autoimmune disorders. Gut. 2002 Jul;51(1):140-1. doi: 10.1136/gut.51.1.140-a. No abstract available.
PMID: 12077109
citation: Verdu EF, Armstrong D, Murray JA. Between celiac disease and irritable bowel syndrome: the "no man's land" of gluten sensitivity. Am J Gastroenterol. 2009 Jun;104(6):1587-94. doi: 10.1038/ajg.2009.188.
PMID: 19455131
citation: Catassi C, Bai JC, Bonaz B, Bouma G, Calabro A, Carroccio A, Castillejo G, Ciacci C, Cristofori F, Dolinsek J, Francavilla R, Elli L, Green P, Holtmeier W, Koehler P, Koletzko S, Meinhold C, Sanders D, Schumann M, Schuppan D, Ullrich R, Vecsei A, Volta U, Zevallos V, Sapone A, Fasano A. Non-Celiac Gluten sensitivity: the new frontier of gluten related disorders. Nutrients. 2013 Sep 26;5(10):3839-53. doi: 10.3390/nu5103839.
PMID: 24077239
citation: Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
PMID: 24275240
responsible party type: Principal Investigator
investigator affiliation: University of Palermo
investigator full name: Pasquale Mansueto
investigator title: Principal investigator
mesh term: Hypersensitivity
mesh term: Autoimmune Diseases