<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/NCT02220166</url>
  </required_header>
  <id_info>
    <org_study_id>GE-GA2-2010</org_study_id>
    <nct_id>NCT02220166</nct_id>
  </id_info>
  <brief_title>Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease</brief_title>
  <official_title>Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat)&#xD;
      have provided conflicting results with some in vitro and ex vivo studies consistent with non&#xD;
      toxicity and other suggestive of toxicity. We recently reported results of a single&#xD;
      administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while&#xD;
      assessing symptoms and changes of intestinal permeability. Although results of intestinal&#xD;
      permeability were inconclusive Tm, but not other type of gluten, was clinically well&#xD;
      tolerated.&#xD;
&#xD;
      The aim of the present study was to assess safety of 60 days of administration of Tm (100&#xD;
      grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on&#xD;
      clinical, serological and histological parameters in Celiac Disease patients on remission&#xD;
      after 1 year of GFD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</primary_completion_date>
  <phase>Phase 2</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>Histologic: 4 duodenal biopsies obtained and classified according to Marsh</measure>
    <time_frame>Baseline, Day 60</time_frame>
    <description>After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>Baseline, Day 30, Day 60</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial</measure>
    <time_frame>Baseline, Day 30, Day 60</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Triticum monococcum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 days of daily administration of 100 grams of water biscuits of Triticum monococcum</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Triticum monococcum</intervention_name>
    <arm_group_label>Triticum monococcum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult Celiac patients on Gluten Free Diet (GFD) for at least one year&#xD;
&#xD;
          -  Strict adherence to GFD&#xD;
&#xD;
          -  Negative Celiac related serology&#xD;
&#xD;
          -  Normal duodenal Histology defined as Marsh Class 0-II&#xD;
&#xD;
          -  Willing to participate and adhere to study protocol&#xD;
&#xD;
          -  Sign of the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#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>Alberto Lanzini, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barbara Zanini, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AO Spedali Civili of Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>I-25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Zanini B, Petroboni B, Not T, Di Toro N, Villanacci V, Lanzarotto F, Pogna N, Ricci C, Lanzini A. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. BMC Gastroenterol. 2013 May 24;13:92. doi: 10.1186/1471-230X-13-92.</citation>
    <PMID>23706063</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Alberto Lanzini, MD PhD</investigator_full_name>
    <investigator_title>Associate Professor of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>Celiac Disease</keyword>
  <keyword>Gluten</keyword>
  <keyword>Gluten free diet</keyword>
  <keyword>Triticum monococcum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celiac Disease</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/NCT02220166
org study id: GE-GA2-2010
nct id: NCT02220166
lead sponsor: 
has dmc: No
Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat)
      have provided conflicting results with some in vitro and ex vivo studies consistent with non
      toxicity and other suggestive of toxicity. We recently reported results of a single
      administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while
      assessing symptoms and changes of intestinal permeability. Although results of intestinal
      permeability were inconclusive Tm, but not other type of gluten, was clinically well
      tolerated.

      The aim of the present study was to assess safety of 60 days of administration of Tm (100
      grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on
      clinical, serological and histological parameters in Celiac Disease patients on remission
      after 1 year of GFD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Histologic: 4 duodenal biopsies obtained and classified according to Marsh
time frame: Baseline, Day 60
description: After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist
measure: Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
time frame: Baseline, Day 30, Day 60
measure: Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial
time frame: Baseline, Day 30, Day 60
arm group label: Triticum monococcum
arm group type: Experimental
description: 60 days of daily administration of 100 grams of water biscuits of Triticum monococcum
intervention type: Dietary Supplement
intervention name: Triticum monococcum
arm group label: Triticum monococcum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alberto Lanzini, MD, PhD
role: Study Chair
affiliation: Università degli Studi di Brescia
last name: Barbara Zanini, MD, PhD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
facility: 
country: Italy
citation: Zanini B, Petroboni B, Not T, Di Toro N, Villanacci V, Lanzarotto F, Pogna N, Ricci C, Lanzini A. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. BMC Gastroenterol. 2013 May 24;13:92. doi: 10.1186/1471-230X-13-92.
PMID: 23706063
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Alberto Lanzini, MD PhD
investigator title: Associate Professor of Gastroenterology
mesh term: Celiac Disease