<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/NCT03298568</url>
  </required_header>
  <id_info>
    <org_study_id>BTS1077/17</org_study_id>
    <nct_id>NCT03298568</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Effect of an Oral Diamine Oxidase Substitution (DAOsin) in Histamine Intolerant Patients on the Low Endogenous Diamine Oxidase Serum Activity</brief_title>
  <official_title>Pilotstudie Zur Untersuchung Der Wirkung Einer Oralen Supplementation Von Diaminooxidase (DAOsin®) Bei Histamin-Intoleranz in Bezug Auf Die Steigerung Der Erniedrigten Endogenen Diaminooxidase-Aktivität</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sciotec Diagnostic Technologies GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sciotec Diagnostic Technologies GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      DAOsin is a food supplement for special medical purpose for the treatment of food intolerance&#xD;
      provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of&#xD;
      an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase&#xD;
      activity in histamine intolerant patients will be examined.&#xD;
&#xD;
      Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for&#xD;
      one month 3 times a day. During this month the diamine oxidase activity is tested biweekly.&#xD;
      Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine&#xD;
      oxidase activity is tested biweekly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">April 16, 2018</completion_date>
  <primary_completion_date type="Actual">December 6, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline activity of diamine oxidase activity in serum</measure>
    <time_frame>1 month treatment with 1 month follow up</time_frame>
    <description>The activity of diamine oxidase is reduced in patients suffering from histamine intolerance. Supplementation with diamine oxidase helps to reduce the level of histamine coming from food entering the circulation. It is already described that people suffering from histamine intolerance following a histamine reduced diet increase their diamine oxidase activity. The purpose is to test if an additional reduction of probably hidden sources of histamine in food through the administration of DAOsin helps to increase the endogenous diamine oxidase activity even further.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms of histamine intolerance</measure>
    <time_frame>1 month with 1 month follow up</time_frame>
    <description>Every proband documents the severity of histamine intolerance symptoms in a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histamine level in plasma</measure>
    <time_frame>1 month with 1 month follow up</time_frame>
    <description>Is the histamine level in plasma changing upon DAOsin treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment</measure>
    <time_frame>1 month with 1 month follow up</time_frame>
    <description>Overall condition during study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Food Intolerance</condition>
  <condition>Histamine Intolerance</condition>
  <arm_group>
    <arm_group_label>DAOsin treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients suffering from histamine intolerance and a diamin oxidase activity below 10 Units/ml get a DAOsin treatment for one month 3 times a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>DAOsin</intervention_name>
    <description>DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.</description>
    <arm_group_label>DAOsin treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diamine oxidase activity &lt; 10 U/ml&#xD;
&#xD;
          -  &gt;= 2 symptoms of histamine intolerance after consumption of histamine containing food&#xD;
&#xD;
          -  18 to 80 years&#xD;
&#xD;
          -  no lactose intolerance&#xD;
&#xD;
          -  no fructose intolerance&#xD;
&#xD;
          -  no tissue transglutaminase antibodies in serum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and nursing&#xD;
&#xD;
          -  cardiopathy&#xD;
&#xD;
          -  instable hypertonie&#xD;
&#xD;
          -  asthma bronchial&#xD;
&#xD;
          -  lactose intolerance, fructose intolerance, coeliac disease&#xD;
&#xD;
          -  severe liver and kidney diseases&#xD;
&#xD;
          -  Known food and other allergies&#xD;
&#xD;
          -  participation in clinical study the last 4 weeks&#xD;
&#xD;
          -  recent (3 months) operation affecting the gastrointestinal tract&#xD;
&#xD;
          -  maligne, infectious or autoimmune gastrointestinal diseases (e.g. IBD)&#xD;
&#xD;
          -  taking histamine liberating drugs on a regular basis&#xD;
&#xD;
          -  taking diamine oxidase inhibiting drugs on a regular basis&#xD;
&#xD;
          -  taking diamine oxidase supplements on a regular basis in the last 4 weeks&#xD;
&#xD;
          -  H1 blocker or Montelukast Therapy 4 month before study start&#xD;
&#xD;
          -  Taking anti histaminica&#xD;
&#xD;
          -  Taking zinc preparations&#xD;
&#xD;
          -  drug, alcohol, pharmaceutical abuses&#xD;
&#xD;
          -  heavy smoking (&gt;15 cigarettes a day)&#xD;
&#xD;
          -  Known HIV infection&#xD;
&#xD;
          -  known acute or chronic hepatitis B and C infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ordination für Innere Medizin und Stoffwechselzentrum</name>
      <address>
        <city>Bruck an der Mur</city>
        <zip>8600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>food intolerance</keyword>
  <keyword>histamine intolerance</keyword>
  <keyword>diamine oxidase</keyword>
  <keyword>DAO</keyword>
  <keyword>DAOsin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Food Intolerance</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/NCT03298568
org study id: BTS1077/17
nct id: NCT03298568
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
DAOsin is a food supplement for special medical purpose for the treatment of food intolerance
      provoked by histamine intake. In this uncontrolled, interventional pilot study the effect of
      an oral diamine oxidase substitution (DAOsin) on the reduced endogenous diamine oxidase
      activity in histamine intolerant patients will be examined.

      Patients with a low endogenous diamine oxidase activity (below 10 Units/ml) take DAOsin for
      one month 3 times a day. During this month the diamine oxidase activity is tested biweekly.
      Afterwards a follow up period of one month without taking DAOsin follows. Again the diamine
      oxidase activity is tested biweekly.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in baseline activity of diamine oxidase activity in serum
time frame: 1 month treatment with 1 month follow up
description: The activity of diamine oxidase is reduced in patients suffering from histamine intolerance. Supplementation with diamine oxidase helps to reduce the level of histamine coming from food entering the circulation. It is already described that people suffering from histamine intolerance following a histamine reduced diet increase their diamine oxidase activity. The purpose is to test if an additional reduction of probably hidden sources of histamine in food through the administration of DAOsin helps to increase the endogenous diamine oxidase activity even further.
measure: Symptoms of histamine intolerance
time frame: 1 month with 1 month follow up
description: Every proband documents the severity of histamine intolerance symptoms in a questionnaire.
measure: Histamine level in plasma
time frame: 1 month with 1 month follow up
description: Is the histamine level in plasma changing upon DAOsin treatment
measure: Global assessment
time frame: 1 month with 1 month follow up
description: Overall condition during study
arm group label: DAOsin treatment
arm group type: Experimental
description: Patients suffering from histamine intolerance and a diamin oxidase activity below 10 Units/ml get a DAOsin treatment for one month 3 times a day.
intervention type: Dietary Supplement
intervention name: DAOsin
description: DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.
arm group label: DAOsin treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Food Intolerance