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/NCT06035328</url>
    </required_header>
    <id_info>
      <org_study_id>069/2566(IRB3)</org_study_id>
      <nct_id>NCT06035328</nct_id>
    </id_info>
    <brief_title>Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy</brief_title>
    <official_title>Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mahidol University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mahidol University</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>
        Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not&#xD;
        standardized, and a wide heterogeneity exists in the literature . So the purpose of our study&#xD;
        is to compare short term unresponsiveness rate between once daily dose and four times/week&#xD;
        dose during one year maintenance phase of wheat OIT&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All subject in this study were patients with history of IgE mediated wheat allergy and&#xD;
        positive OFC test. All of them received wheat OIT and reached target maintenance dose of&#xD;
        wheat OIT.&#xD;
  &#xD;
        The primary outcome was to compare short term unresponsiveness rate between once daily dose&#xD;
        and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were&#xD;
        collected during the projected such as blood and skin examination for immunologic parameter,&#xD;
        changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication&#xD;
        used during OIT and quality of life&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">March 22, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 22, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Short term unresponsiveness rate</measure>
      <time_frame>13 months</time_frame>
      <description>Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT.&#xD;
  Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Specific IgE to wheat</measure>
      <time_frame>13 months</time_frame>
      <description>Specific IgE to wheat</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specific IgG4 to wheat</measure>
      <time_frame>13 months</time_frame>
      <description>Specific IgG4 to wheat</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changing in Body weight</measure>
      <time_frame>13 months</time_frame>
      <description>Changing in Body weight in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compliance</measure>
      <time_frame>12 months</time_frame>
      <description>Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>13 months</time_frame>
      <description>Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life by using FAQLQ-PF</measure>
      <time_frame>13 months</time_frame>
      <description>Quality of life before and after enrollment by using FAQLQ-PF</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Wheat Hypersensitivity</condition>
    <condition>Immunotherapy</condition>
    <arm_group>
      <arm_group_label>Four per week</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Once daily</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Wheat (Four times per week)</intervention_name>
      <description>Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT</description>
      <arm_group_label>Four per week</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 5-18 years old&#xD;
  &#xD;
            -  Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC&#xD;
               test&#xD;
  &#xD;
            -  Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat&#xD;
               OIT&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with low dose OIT protocol&#xD;
  &#xD;
            -  Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic&#xD;
               disease;&#xD;
  &#xD;
            -  Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or&#xD;
               biologic therapy (eg, Omalizumab)&#xD;
  &#xD;
            -  Patients with a developmental problem or mental disorder&#xD;
  &#xD;
            -  Active eosinophilic gastrointestinal disease in the past 2 years&#xD;
  &#xD;
            -  Use of b-blockers (oral), angiotensin-converting enzyme inhibitors,&#xD;
               angiotensin-receptor blockers, or calcium-channel blockers&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Patient who could not visit clinic as protocol&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Punchama Pacharn, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mahidol University, Siriraj Hospital,Thailand</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Punchama Pacharn, MD</last_name>
      <phone>024197000</phone>
      <phone_ext>5670</phone_ext>
      <email>punchama@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Siriraj Hospital</name>
        <address>
          <city>Bangkoknoi</city>
          <state>Bangkok</state>
          <zip>10700</zip>
          <country>Thailand</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Punchama Pacharn, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Thailand</country>
    </location_countries>
    <reference>
      <citation>Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.</citation>
      <PMID>29205393</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Wheat Hypersensitivity</keyword>
    <keyword>Immunotherapy</keyword>
    <keyword>Short term unresponsiveness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
      <mesh_term>Wheat Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06035328
  org study id: 069/2566(IRB3)
  nct id: NCT06035328
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not
        standardized, and a wide heterogeneity exists in the literature . So the purpose of our study
        is to compare short term unresponsiveness rate between once daily dose and four times/week
        dose during one year maintenance phase of wheat OIT
  All subject in this study were patients with history of IgE mediated wheat allergy and
        positive OFC test. All of them received wheat OIT and reached target maintenance dose of
        wheat OIT.
  
        The primary outcome was to compare short term unresponsiveness rate between once daily dose
        and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were
        collected during the projected such as blood and skin examination for immunologic parameter,
        changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication
        used during OIT and quality of life
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Short term unresponsiveness rate
  time frame: 13 months
  description: Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT.
  Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period
  measure: Specific IgE to wheat
  time frame: 13 months
  description: Specific IgE to wheat
  measure: Specific IgG4 to wheat
  time frame: 13 months
  description: Specific IgG4 to wheat
  measure: Changing in Body weight
  time frame: 13 months
  description: Changing in Body weight in kilograms
  measure: Compliance
  time frame: 12 months
  description: Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption.
  measure: Adverse reactions
  time frame: 13 months
  description: Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
  measure: Quality of life by using FAQLQ-PF
  time frame: 13 months
  description: Quality of life before and after enrollment by using FAQLQ-PF
  arm group label: Four per week
  arm group type: Experimental
  description: Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
  arm group label: Once daily
  arm group type: No Intervention
  description: Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT
  intervention type: Other
  intervention name: Wheat (Four times per week)
  description: Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
  arm group label: Four per week
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Punchama Pacharn, MD
  role: Principal Investigator
  affiliation: Mahidol University, Siriraj Hospital,Thailand
  last name: Punchama Pacharn, MD
  phone: 024197000
  phone ext: 5670
  email: punchama@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Thailand
  citation: Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
  PMID: 29205393
  responsible party type: Sponsor
  mesh term: Hypersensitivity
  mesh term: Wheat Hypersensitivity
  sharing ipd: No