<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/NCT03002584</url>
  </required_header>
  <id_info>
    <org_study_id>IGQ</org_study_id>
    <nct_id>NCT03002584</nct_id>
  </id_info>
  <brief_title>International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)</brief_title>
  <acronym>PRoVING</acronym>
  <official_title>International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Paris 7 - Denis Diderot</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EA 7334, Patient-Centered Outcomes Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Vall d'Hebron</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Louis Mourier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Paris 7 - Denis Diderot</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)&#xD;
      in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both&#xD;
      complaining of Gas-Related Symptoms (GRS).&#xD;
&#xD;
      IGQ has been developed previously simultaneously in UK English, French and Spanish through&#xD;
      qualitative research with subject interviews. The conceptual framework of the IGQ assesses&#xD;
      both GRS and their impact on daily life. Similar concepts were identified for both subjects&#xD;
      with IBS diagnosis and general population and complaining of gas-related symptoms.&#xD;
&#xD;
      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17&#xD;
      items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26&#xD;
      items)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational (non-interventional) study with a cross-sectional part for a subset of adult&#xD;
      subjects with a single IGQ completion and a longitudinal cross-over part for a subset of&#xD;
      subjects with test-retest IGQ completion for validation of electronic version of IGQ.&#xD;
&#xD;
      300 eligible subjects (100 in each of the 3 countries: France, UK &amp; Spain):&#xD;
&#xD;
        -  180 with IBS diagnosis (60% of recruited subjects)&#xD;
&#xD;
        -  120 from General population (40% of recruited subjects)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">July 10, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychometric validation of the IGQ</measure>
    <time_frame>cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants</time_frame>
    <description>Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electronic version of the IGQ</measure>
    <time_frame>During test-retest within an interval of 7 days</time_frame>
    <description>Comparison of scores between paper and electronic version of IGQ</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>IBS - Irritable Bowel Syndrome</condition>
  <condition>General Population</condition>
  <arm_group>
    <arm_group_label>IBS &amp; general population</arm_group_label>
    <description>The participants will be given the IGQ questionnaire to complete as well as other self-reported questionnaires.&#xD;
Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).&#xD;
Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>completion of self-reported questionnaires</intervention_name>
    <description>Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).&#xD;
Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale</description>
    <arm_group_label>IBS &amp; general population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        IBS patients and subjects from general population complaining of Gas-Related Symptoms (GRS)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All (subjects with IBS diagnosis and general population):&#xD;
&#xD;
          -  Complaining of gas-related symptoms (GRS) of a certain severity level: subjects with&#xD;
             IBS diagnosis and general population need to report a score of 4 or greater on at&#xD;
             least one symptom on the symptom screening tool&#xD;
&#xD;
          -  Cognitive and linguistic capability to complete several self-questionnaires&#xD;
&#xD;
          -  BMI &gt; 18.5 and &lt; 30.0 kg/m2&#xD;
&#xD;
          -  Agreement of the subject to participate in the study&#xD;
&#xD;
        Subjects with IBS diagnosis:&#xD;
&#xD;
          -  IBS diagnosis using Rome III diagnostic criteria for Functional Gastrointestinal&#xD;
             Disorders (21)&#xD;
&#xD;
          -  IBS severity: IBS-SSS score of 75 to 300&#xD;
&#xD;
        General population:&#xD;
&#xD;
          -  Subjects not fulfilling IBS Rome III criteria&#xD;
&#xD;
          -  Regular stool frequency (i.e., between 3 and 21 bowel movements per week)&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        All (subjects with IBS diagnosis and general population):&#xD;
&#xD;
          -  Recent (2 last weeks) change in diet or intake of potentially flatulogenic compounds&#xD;
             (fiber, lactulose)&#xD;
&#xD;
          -  Organic gastrointestinal disease&#xD;
&#xD;
          -  Other functional gastrointestinal disorder as defined by Rome III criteria&#xD;
&#xD;
          -  Any severe and progressive disease (e.g. depression, cancer, uncontrolled diabetes,&#xD;
             rheumatoid arthritis…)&#xD;
&#xD;
          -  Any severe psychiatric disorder (e.g. acute episode of schizophrenia or bipolar&#xD;
             disorder…)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Being under the direct hierarchy of the investigatorBelonging to the site's staff team&#xD;
&#xD;
        General population:&#xD;
&#xD;
          -  Treatment for diarrhea or constipation including lactulose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivier Chassany, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>EA 7334, University Paris-Diderot, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Whorwell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>university of Manchester, Manchester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando Azpiroz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron, Barcelona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benoit Coffin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Louis Mourier, Colombes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Duracinsky, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>EA 7334, University Paris-Diderot, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Louis Mourier</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de salud Chafarinas</name>
      <address>
        <city>Barcelona</city>
        <zip>08033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horta, Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Mèdic Sant Andreu</name>
      <address>
        <city>Barcelona</city>
        <zip>08740</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Chassany O, Tugaut B, Marrel A, Guyonnet D, Arbuckle R, Duracinsky M, Whorwell PJ, Azpiroz F. The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life. Neurogastroenterol Motil. 2015 Jun;27(6):885-98. doi: 10.1111/nmo.12565. Epub 2015 Apr 6.</citation>
    <PMID>25846412</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Paris 7 - Denis Diderot</investigator_affiliation>
    <investigator_full_name>Olivier CHASSANY</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>IBS, population</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</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/NCT03002584
org study id: IGQ
nct id: NCT03002584
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ)
      in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both
      complaining of Gas-Related Symptoms (GRS).

      IGQ has been developed previously simultaneously in UK English, French and Spanish through
      qualitative research with subject interviews. The conceptual framework of the IGQ assesses
      both GRS and their impact on daily life. Similar concepts were identified for both subjects
      with IBS diagnosis and general population and complaining of gas-related symptoms.

      The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17
      items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26
      items)
Observational (non-interventional) study with a cross-sectional part for a subset of adult
      subjects with a single IGQ completion and a longitudinal cross-over part for a subset of
      subjects with test-retest IGQ completion for validation of electronic version of IGQ.

      300 eligible subjects (100 in each of the 3 countries: France, UK & Spain):

        -  180 with IBS diagnosis (60% of recruited subjects)

        -  120 from General population (40% of recruited subjects)
observational model: Cohort
time perspective: Prospective
measure: Psychometric validation of the IGQ
time frame: cross sectional for 70% of participants and test-retest within an interval of 7 days for 30% of participants
description: Stastistical analysis to confirm the psychometric validation of the IGQ questionnaire
measure: Electronic version of the IGQ
time frame: During test-retest within an interval of 7 days
description: Comparison of scores between paper and electronic version of IGQ
arm group label: IBS & general population
description: The participants will be given the IGQ questionnaire to complete as well as other self-reported questionnaires.
Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).
Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale.
intervention type: Other
intervention name: completion of self-reported questionnaires
description: Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).
Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale
arm group label: IBS & general population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Olivier Chassany, MD, PhD
role: Study Chair
affiliation: EA 7334, University Paris-Diderot, Paris
last name: Peter Whorwell, MD, PhD
role: Principal Investigator
affiliation: university of Manchester, Manchester
last name: Fernando Azpiroz, MD, PhD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron, Barcelona
last name: Benoit Coffin, MD, PhD
role: Principal Investigator
affiliation: Hopital Louis Mourier, Colombes
last name: Martin Duracinsky, MD, PhD
role: Study Director
affiliation: EA 7334, University Paris-Diderot, Paris
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Spain
country: United Kingdom
citation: Chassany O, Tugaut B, Marrel A, Guyonnet D, Arbuckle R, Duracinsky M, Whorwell PJ, Azpiroz F. The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life. Neurogastroenterol Motil. 2015 Jun;27(6):885-98. doi: 10.1111/nmo.12565. Epub 2015 Apr 6.
PMID: 25846412
responsible party type: Principal Investigator
investigator affiliation: University Paris 7 - Denis Diderot
investigator full name: Olivier CHASSANY
investigator title: Professor
mesh term: Irritable Bowel Syndrome
sharing ipd: No