<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/NCT01695681</url>
  </required_header>
  <id_info>
    <org_study_id>2011/1943 (REK)</org_study_id>
    <nct_id>NCT01695681</nct_id>
  </id_info>
  <brief_title>Screen-detected Coeliac Disease, a Population Based Study</brief_title>
  <official_title>Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Norwegian Coeliac Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Gastrointestinal Research Foundation, University Hospital of NorthNorway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of North Norway</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the prevalence of previously undiagnosed coeliac&#xD;
      disease based on a health survey from Tromsø, Norway. Moreover, the health impact of&#xD;
      undiagnosed coeliac disease will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few population-based studies have examined the prevalence of coeliac disease and the impact&#xD;
      of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed&#xD;
      coeliac disease is much higher than the number who know their diagnosis.&#xD;
&#xD;
      The purpose of this study is to determine the prevalence of coeliac disease and the impact of&#xD;
      undiagnosed coeliac disease on health.&#xD;
&#xD;
      In a health survey of the population of Tromsø Norway, serological markers of coeliac disease&#xD;
      (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed.&#xD;
      Individuals with increased level of one of these markers, will be invited for upper endoscopy&#xD;
      with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons&#xD;
      with screen detected coeliac disease, will be advised to start a gluten free diet.&#xD;
&#xD;
      Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms&#xD;
      Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.&#xD;
&#xD;
        1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy&#xD;
           verified coeliac disease and compared with a group of healthy control persons from the&#xD;
           health-survey cohort.&#xD;
&#xD;
        2. In a prospective study of the persons with screen detected coeliac disease, health&#xD;
           status (GSRS) and Quality of Life will be compared before and after one year on a gluten&#xD;
           free diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">April 15, 2015</completion_date>
  <primary_completion_date type="Actual">April 15, 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)</measure>
    <time_frame>7 days</time_frame>
    <description>The Gastrointestinal symptoms rating scale (GSRS) is a disease-specific instrument with 15 items combined into five major domains: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation.&#xD;
The scale assesses symptom severity using a seven-grade Likert scale, ranging from 1 (no discomfort at all) to 7 (very severe discomfort). A lower score indicates less symptoms.&#xD;
GSRS is obtained at first visit and at follow-up (&gt;one year) to evaluate change in one of the five domain scores or total score (primary outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life score: Psychological General Well-Being Index (PGWBI)</measure>
    <time_frame>7 days</time_frame>
    <description>The Psychological General Well-Being Index (PGWBI) is a generic instrument with 22 items combined into six major domains: Anxiety, Depressed Mode, Positive well-being, Self-control, General Health and Vitality&#xD;
The scale assesses symptom severity from 0 to 5. Higher score indicates a better psychological well being.&#xD;
PGWB is obtained at first visit and at follow-up (&gt;one year) to evaluate change in one of the six domains or total score (secondary outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported change in abdominal complaints</measure>
    <time_frame>One year</time_frame>
    <description>Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about abdominal complaints after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from &quot;very much worse&quot; to &quot;very much better&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported change in energy</measure>
    <time_frame>One year</time_frame>
    <description>Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about energy/feeling-fit after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from &quot;very much worse&quot; to &quot;very much better&quot;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Celiac Disease</condition>
  <arm_group>
    <arm_group_label>Dietary instruction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gluten-free diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gluten-free diet</intervention_name>
    <description>Dietary advice by clinical dietitian</description>
    <arm_group_label>Dietary instruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and&#xD;
             biopsy verified coeliac disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously diagnosed coeliac disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>87 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan- M Kvamme, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tromso</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Trond Halstensen, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of life</keyword>
  <keyword>Celiac Disease/diet therapy</keyword>
  <keyword>Celiac Disease/diagnosis</keyword>
  <keyword>Prospective Studies</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/NCT01695681
org study id: 2011/1943 (REK)
nct id: NCT01695681
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine the prevalence of previously undiagnosed coeliac
      disease based on a health survey from Tromsø, Norway. Moreover, the health impact of
      undiagnosed coeliac disease will be examined.
Few population-based studies have examined the prevalence of coeliac disease and the impact
      of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed
      coeliac disease is much higher than the number who know their diagnosis.

      The purpose of this study is to determine the prevalence of coeliac disease and the impact of
      undiagnosed coeliac disease on health.

      In a health survey of the population of Tromsø Norway, serological markers of coeliac disease
      (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed.
      Individuals with increased level of one of these markers, will be invited for upper endoscopy
      with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons
      with screen detected coeliac disease, will be advised to start a gluten free diet.

      Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms
      Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.

        1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy
           verified coeliac disease and compared with a group of healthy control persons from the
           health-survey cohort.

        2. In a prospective study of the persons with screen detected coeliac disease, health
           status (GSRS) and Quality of Life will be compared before and after one year on a gluten
           free diet.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS)
time frame: 7 days
description: The Gastrointestinal symptoms rating scale (GSRS) is a disease-specific instrument with 15 items combined into five major domains: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation.
The scale assesses symptom severity using a seven-grade Likert scale, ranging from 1 (no discomfort at all) to 7 (very severe discomfort). A lower score indicates less symptoms.
GSRS is obtained at first visit and at follow-up (>one year) to evaluate change in one of the five domain scores or total score (primary outcome)
measure: Quality of life score: Psychological General Well-Being Index (PGWBI)
time frame: 7 days
description: The Psychological General Well-Being Index (PGWBI) is a generic instrument with 22 items combined into six major domains: Anxiety, Depressed Mode, Positive well-being, Self-control, General Health and Vitality
The scale assesses symptom severity from 0 to 5. Higher score indicates a better psychological well being.
PGWB is obtained at first visit and at follow-up (>one year) to evaluate change in one of the six domains or total score (secondary outcome)
measure: Self-reported change in abdominal complaints
time frame: One year
description: Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about abdominal complaints after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from "very much worse" to "very much better"
measure: Self-reported change in energy
time frame: One year
description: Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about energy/feeling-fit after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from "very much worse" to "very much better"
arm group label: Dietary instruction
arm group type: Other
description: Gluten-free diet
intervention type: Other
intervention name: Gluten-free diet
description: Dietary advice by clinical dietitian
arm group label: Dietary instruction
criteria: 
gender: All
minimum age: 30 Years
maximum age: 87 Years
healthy volunteers: No
last name: Jan- M Kvamme, MD PhD
role: Principal Investigator
affiliation: University of Tromso
last name: Trond Halstensen, MD PhD
role: Study Chair
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Celiac Disease