<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/NCT04462978</url>
  </required_header>
  <id_info>
    <org_study_id>102/20</org_study_id>
    <nct_id>NCT04462978</nct_id>
  </id_info>
  <brief_title>Non-Immunoglobulin E-mediated Food Allergies in Children</brief_title>
  <acronym>NIGEFA</acronym>
  <official_title>Investigating Clinical Features, Natural Course and Pathophysiology of Non-Immunoglobulin E-mediated Food Allergies in the Pediatric Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of&#xD;
      clinical conditions characterized by subacute and/or chronic symptoms and include food&#xD;
      protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food&#xD;
      protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility&#xD;
      disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).&#xD;
&#xD;
      Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as&#xD;
      the natural history and the best management of these disorders are still poorly defined.&#xD;
      These limitations could be responsible for diagnostic delays and errors, and suboptimal&#xD;
      clinical management. We aim to evaluate clinical features, natural course and pathophysiology&#xD;
      of non-IgE-GIFA in the pediatric age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 28, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of clinical features and disease course of non-IgE mediated food allergies in children</measure>
    <time_frame>After 72 months from the study start</time_frame>
    <description>Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of clinical features of non-IgE mediated food allergies in children</measure>
    <time_frame>After 72 months from the study start</time_frame>
    <description>Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Evaluation of serum levels of Th2, Th1, and Th17 cytokines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Evaluation of epigenetic mechanisms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Evaluation of immune cells phenotype</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Evaluation of mithocondrial metabolism of human lymphocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Evaluation of gut microbiome structure and function</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Non IgE Mediated Food Allergy</condition>
  <condition>Food Protein-Induced Enteropathy</condition>
  <condition>Food Protein-Induced Proctocolitis</condition>
  <condition>Food Protein-Induced Enterocolitis Syndrome</condition>
  <condition>Food Protein-induced Motility Disorders</condition>
  <arm_group>
    <arm_group_label>Non IgE-mediated food allergy</arm_group_label>
    <description>Children with non IgE-mediated food allergy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non IgE-mediated food allergy</intervention_name>
    <arm_group_label>Non IgE-mediated food allergy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples Peripheral blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects consecutively observed at the Pediatric Allergy Program, at the Department of&#xD;
        Translational Medical Science of the University of Naples Federico II, both sex, aged&#xD;
        between 0-14 years with suggestive history of food allergy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects aged between 0-14 years&#xD;
&#xD;
          -  suggestive history of food allergy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;14 years-&#xD;
&#xD;
          -  chronic systemic diseases,&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  immunodeficiency,&#xD;
&#xD;
          -  infectious diseases,&#xD;
&#xD;
          -  autoimmune diseases,&#xD;
&#xD;
          -  inflammatory bowel diseases,&#xD;
&#xD;
          -  celiac disease,&#xD;
&#xD;
          -  metabolic and genetic diseases,&#xD;
&#xD;
          -  cystic fibrosis,&#xD;
&#xD;
          -  chronic pulmonary diseases,&#xD;
&#xD;
          -  gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,&#xD;
&#xD;
          -  neurologic and/or neuropsychiatric disorders,&#xD;
&#xD;
          -  gastrointestinal tract eosinophilic disorders,&#xD;
&#xD;
          -  use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the&#xD;
             previous 4 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Berni Canani, MD, PhD</last_name>
      <phone>+390817462680</phone>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Roberto Berni Canani, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Food allergy</keyword>
  <keyword>Adverse food reactions</keyword>
  <keyword>Immune tolerance</keyword>
  <keyword>Atopy patch test</keyword>
  <keyword>Atopic march</keyword>
  <keyword>Oral food challenge</keyword>
  <keyword>Food Protein-Induced Enteropathy</keyword>
  <keyword>Food Protein-Induced Proctocolitis</keyword>
  <keyword>Food Protein-Induced Enterocolitis Syndrome</keyword>
  <keyword>Food protein-induced motility disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Proctocolitis</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Food Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04462978
org study id: 102/20
nct id: NCT04462978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of
      clinical conditions characterized by subacute and/or chronic symptoms and include food
      protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food
      protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility
      disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).

      Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as
      the natural history and the best management of these disorders are still poorly defined.
      These limitations could be responsible for diagnostic delays and errors, and suboptimal
      clinical management. We aim to evaluate clinical features, natural course and pathophysiology
      of non-IgE-GIFA in the pediatric age.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of clinical features and disease course of non-IgE mediated food allergies in children
time frame: After 72 months from the study start
description: Rate of pts affected by FPIES, FPE, FPIAP, FPIMD; diagnostic delay; disease duration, rate of pts with mono vs poli food allergies; main antigens responsible for the diseases; occurrence of atopic dermatitis before food allergy onset; results of allergy screening tests; occurrence of atopic march
measure: Evaluation of clinical features of non-IgE mediated food allergies in children
time frame: After 72 months from the study start
description: Dietary management and Nutritional status (weight and height will be combined to report BMI z-score)
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
time frame: through study completion, an average of 2 years
description: Evaluation of serum levels of Th2, Th1, and Th17 cytokines
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
time frame: through study completion, an average of 2 years
description: Evaluation of epigenetic mechanisms
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
time frame: through study completion, an average of 2 years
description: Evaluation of immune cells phenotype
measure: Evaluation of immune mechanisms involved in the pathogenesis of non-IgE mediated food allergies in children
time frame: through study completion, an average of 2 years
description: Evaluation of mithocondrial metabolism of human lymphocytes
measure: Evaluation of gut microbiome features in children with Non-IgE-mediated food allergies
time frame: through study completion, an average of 2 years
description: Evaluation of gut microbiome structure and function
arm group label: Non IgE-mediated food allergy
description: Children with non IgE-mediated food allergy
intervention type: Other
intervention name: Non IgE-mediated food allergy
arm group label: Non IgE-mediated food allergy
Stool samples Peripheral blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Roberto Berni Canani, MD, PhD
investigator title: Professor of Pediatrics
mesh term: Enterocolitis
mesh term: Intestinal Diseases
mesh term: Proctocolitis
mesh term: Hypersensitivity
mesh term: Food Hypersensitivity
sharing ipd: Undecided