<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/NCT02979600</url>
  </required_header>
  <id_info>
    <org_study_id>OBS-051</org_study_id>
    <nct_id>NCT02979600</nct_id>
  </id_info>
  <brief_title>Clinical and Biological Efficacy of Peanut Oral Immunotherapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent&#xD;
      Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing&#xD;
      patients to regularly increasing doses of allergen. This protocol induces an increase of the&#xD;
      threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and&#xD;
      a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The&#xD;
      protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut&#xD;
      proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut&#xD;
      that can be found in standard product in France.&#xD;
&#xD;
      The investigators wish to study the evolution of the threshold reactive dose and of the sIgE&#xD;
      of patients that have followed the OTI protocol. All the needed data are available in the&#xD;
      medical records so the study will be conducted on retrospective data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prevalence of food allergy is estimated at 3.5% in Europe. In particular, peanut allergy&#xD;
      prevalence in France is between 0.3% and 0.75%, when it is 1% in the US, UK and Canada.&#xD;
      Peanut allergy is a severe allergy, second behind tree nut allergy in the general population,&#xD;
      with a risk of fatal reactions. The risk is especially high for young adults. It is also a&#xD;
      long lasting condition with only 20% of natural healing that happened most of the time&#xD;
      between 6 and 8y.o. These last years, the only proposed &quot;treatment&quot; was an elimination diet.&#xD;
      However, it has been proved that it makes allergy severity worse, and sensitization and&#xD;
      reactivity increase with time. Elimination diet can also lead to the apparition of&#xD;
      avoidant/restrictive food intake disorders, and has a major impact on patient habits, causing&#xD;
      patient quality of life to decrease.&#xD;
&#xD;
      In view of the risks and limits of an elimination diet and the low natural healing rate, a&#xD;
      therapeutic alternative has been proposed with the development of peanut oral tolerance&#xD;
      induction (OTI) protocols. As sublingual immunotherapies have low efficacies and as injection&#xD;
      strategies have a high risk of severe allergic reactions, oral route is preferred. This&#xD;
      strategy needs to ensure patients an increasing tolerance to the allergen, thus limiting the&#xD;
      risks of anaphylactic shock at low doses, but also needs to ensure patient safety, with&#xD;
      controlled risks of secondary reactions at home. It can be followed by young patients, its&#xD;
      efficiency being increased. An OTI protocol is conducted at the allergy Unit of Saint Vincent&#xD;
      Hospital of Lille (France) in standard care since 2006. It consists in daily giving small&#xD;
      peanut doses to the patient, and to regularly increase those doses.&#xD;
&#xD;
      For this OTI protocol, an oral food challenge (OFC) is performed. This OFC allows the&#xD;
      determination of the threshold reactive dose, i.e. the minimum dose of allergen that induces&#xD;
      an allergic reaction. A safe dose of peanut is then determined that will be regularly eaten&#xD;
      by the patient. Every 6 months, a new OFC is performed and thus a new threshold reactive dose&#xD;
      is measured, and the dose to be eaten by the patient updated. The protocol is followed until&#xD;
      the patient reaches an ideal dose of 2942mg of peanut protein, corresponding to 14 peanuts of&#xD;
      middle size, which is the maximum dose of peanut that can be found in standard product in&#xD;
      France. Of course, the protocol can also be ended if the patient decided so.&#xD;
&#xD;
      Although this protocol is performed in the allergy Unit of Saint Vincent Hospital, very few&#xD;
      data are published on the subject. The aim of the study is to study the evolution of the&#xD;
      threshold reactive dose and the evolution of the quantity of specific immunoglobulin E (sIgE)&#xD;
      against peanut proteins (rAra h 1, rAra h 2 and rAra h 3) in patient that had followed the&#xD;
      protocol.&#xD;
&#xD;
      The main objective of this study is to study the clinical efficiency of peanut OTI by&#xD;
      measuring the evolution of the patient threshold reactive dose.&#xD;
&#xD;
      The secondary objective is to study the biological efficiency of peanut OTI by measuring the&#xD;
      evolution of the dosage of sIgE against peanut proteins.&#xD;
&#xD;
      As the OFC and the IgE dosage are a standard part of the OTI protocol, all the data are&#xD;
      obtained from the medical records. The study is retrospective and thus observational.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the threshold reactive dose in milligrams</measure>
    <time_frame>At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)</time_frame>
    <description>During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 2942mg of peanut protein, or until the patient decide to end it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of IgE dosages against Arah1, 2 and 3</measure>
    <time_frame>At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)</time_frame>
    <description>Dosage of the specific IgE against peanut proteins, rAra h 1, rAra h 2 and rArah 3, that are performed every 6 months during the standard follow-up of the patients. The measures are done with ImmunoCAP laboratory system, Phadia, Uppsala, Sweden.</description>
  </secondary_outcome>
  <enrollment type="Actual">493</enrollment>
  <condition>Peanut Allergy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Peanut allergic patients that have followed a peanut oral tolerance induction protocol at&#xD;
        the allergy Unit of Saint Vincent Hospital of Lille (France) since 2005&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinical symptoms when consuming peanuts, such as urticaria, asthma,&#xD;
             angioedema, atopic dermatitis, dermo-respiratory syndrome or anaphylactic shock.&#xD;
&#xD;
          -  Positive sIgE against r Ara h 2 dosage, i.e. r Ara h 2 &gt;0.1&#xD;
&#xD;
          -  Patients that had followed a peanut oral tolerance induction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No clinical symptoms or biological confirmation of a peanut allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxime Seynave, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral immunotherapy</keyword>
  <keyword>Oral tolerance induction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peanut 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>


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/NCT02979600
org study id: OBS-051
nct id: NCT02979600
lead sponsor: 
has dmc: Yes
An oral tolerance induction (OTI) protocol is conducted at the allergy Unit of Saint Vincent
      Hospital of Lille (France) in standard care since 2006. This protocol consists in exposing
      patients to regularly increasing doses of allergen. This protocol induces an increase of the
      threshold reactive dose (the minimum dose of allergen that triggered a reactive reaction) and
      a decrease of the quantity of specific immunoglobulin E (sIgE) against peanut proteins. The
      protocol is ended when the patient reaches a threshold reactive dose of 2942mg of peanut
      proteins, corresponding to 14 peanuts of middle size, which is the maximum dose of peanut
      that can be found in standard product in France.

      The investigators wish to study the evolution of the threshold reactive dose and of the sIgE
      of patients that have followed the OTI protocol. All the needed data are available in the
      medical records so the study will be conducted on retrospective data.
Prevalence of food allergy is estimated at 3.5% in Europe. In particular, peanut allergy
      prevalence in France is between 0.3% and 0.75%, when it is 1% in the US, UK and Canada.
      Peanut allergy is a severe allergy, second behind tree nut allergy in the general population,
      with a risk of fatal reactions. The risk is especially high for young adults. It is also a
      long lasting condition with only 20% of natural healing that happened most of the time
      between 6 and 8y.o. These last years, the only proposed "treatment" was an elimination diet.
      However, it has been proved that it makes allergy severity worse, and sensitization and
      reactivity increase with time. Elimination diet can also lead to the apparition of
      avoidant/restrictive food intake disorders, and has a major impact on patient habits, causing
      patient quality of life to decrease.

      In view of the risks and limits of an elimination diet and the low natural healing rate, a
      therapeutic alternative has been proposed with the development of peanut oral tolerance
      induction (OTI) protocols. As sublingual immunotherapies have low efficacies and as injection
      strategies have a high risk of severe allergic reactions, oral route is preferred. This
      strategy needs to ensure patients an increasing tolerance to the allergen, thus limiting the
      risks of anaphylactic shock at low doses, but also needs to ensure patient safety, with
      controlled risks of secondary reactions at home. It can be followed by young patients, its
      efficiency being increased. An OTI protocol is conducted at the allergy Unit of Saint Vincent
      Hospital of Lille (France) in standard care since 2006. It consists in daily giving small
      peanut doses to the patient, and to regularly increase those doses.

      For this OTI protocol, an oral food challenge (OFC) is performed. This OFC allows the
      determination of the threshold reactive dose, i.e. the minimum dose of allergen that induces
      an allergic reaction. A safe dose of peanut is then determined that will be regularly eaten
      by the patient. Every 6 months, a new OFC is performed and thus a new threshold reactive dose
      is measured, and the dose to be eaten by the patient updated. The protocol is followed until
      the patient reaches an ideal dose of 2942mg of peanut protein, corresponding to 14 peanuts of
      middle size, which is the maximum dose of peanut that can be found in standard product in
      France. Of course, the protocol can also be ended if the patient decided so.

      Although this protocol is performed in the allergy Unit of Saint Vincent Hospital, very few
      data are published on the subject. The aim of the study is to study the evolution of the
      threshold reactive dose and the evolution of the quantity of specific immunoglobulin E (sIgE)
      against peanut proteins (rAra h 1, rAra h 2 and rAra h 3) in patient that had followed the
      protocol.

      The main objective of this study is to study the clinical efficiency of peanut OTI by
      measuring the evolution of the patient threshold reactive dose.

      The secondary objective is to study the biological efficiency of peanut OTI by measuring the
      evolution of the dosage of sIgE against peanut proteins.

      As the OFC and the IgE dosage are a standard part of the OTI protocol, all the data are
      obtained from the medical records. The study is retrospective and thus observational.
observational model: Case-Only
time perspective: Retrospective
measure: Evolution of the threshold reactive dose in milligrams
time frame: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)
description: During the OTI protocol, an oral food challenge is performed every 6 months. The dose that induce the first allergic reaction is reported. The protocol is followed until the patients get a threshold reactive dose of 2942mg of peanut protein, or until the patient decide to end it.
measure: Evolution of IgE dosages against Arah1, 2 and 3
time frame: At inclusion, then every 6 months until a threshold reactive dose of 2942mg of peanut protein is reached (up to 7 years)
description: Dosage of the specific IgE against peanut proteins, rAra h 1, rAra h 2 and rArah 3, that are performed every 6 months during the standard follow-up of the patients. The measures are done with ImmunoCAP laboratory system, Phadia, Uppsala, Sweden.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Maxime Seynave, MD
role: Principal Investigator
affiliation: GHICL
responsible party type: Sponsor
mesh term: Peanut Hypersensitivity
sharing ipd: No