<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/NCT03824821</url>
  </required_header>
  <id_info>
    <org_study_id>18/06</org_study_id>
    <nct_id>NCT03824821</nct_id>
  </id_info>
  <brief_title>Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire</brief_title>
  <acronym>IBSQUtrition</acronym>
  <official_title>Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Netherlands: Ministry of Health, Welfare and Sports</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ingredia S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nexira</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naturex</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bioiberica</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wecare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roquette Freres</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Darling</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Winclove Probiotics B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a cross-sectional observational study design that aimed to include 2000 IBS&#xD;
      patients. We used several validated questionnaires, to assess IBS characteristics (such as&#xD;
      subtype, severity), psychological features (QoL, anxiety and depression) and assess&#xD;
      nutritional triggers.&#xD;
&#xD;
      Subjects filled in the questionnaire online, and was spread across the Netherlands.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IBS subtype</measure>
    <time_frame>1 day (once )</time_frame>
    <description>Assessed using the Validated Bristol stool chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IBS severity</measure>
    <time_frame>1 day (once )</time_frame>
    <description>Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nutrition questionnaire</measure>
    <time_frame>1 day (once )</time_frame>
    <description>We composed a questionnaire containing 44 identified nutritional triggers from literature, and asked subjects if they had (0, no complaints), 1 little complaints, 2 severe complaints, after eating that product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Birmingham symptom questionnaire</measure>
    <time_frame>1 day (once )</time_frame>
    <description>Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Irritable bowel syndrome Quality of Life questionnaire</measure>
    <time_frame>1 day (once )</time_frame>
    <description>We used the validated IBS-QOL which asked 44 questions about quality of life related to IBS. Score ranged from 0 - 100: 100 indicating a very high quality of life, 0 indicating a very poor quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Score (HADS)</measure>
    <time_frame>1 day (once )</time_frame>
    <description>We used the validated HADS questionnaire to assess anxiety and depression in IBS patients. This questionnaire gives 2 scores: one for anxiety and depression. Scores range from 0-21, a score above 8 can be referred to as being a case for having anxiety or depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment options currently used</measure>
    <time_frame>1 day (once )</time_frame>
    <description>We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rome IV criteria</measure>
    <time_frame>1 day (once )</time_frame>
    <description>Validated questions to check whether a subject fits within the profile of IBS</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2076</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>IBS</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>IBS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        There were no strict inclusion and exclusion criteria, since many IBS patients do not have&#xD;
        an official diagnosis of IBS. therefore, the ROME IV diagnostic criteria were included in&#xD;
        the questionnaire, to assess whether subjects fit within the IBS profile.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IBS-like symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Wageningen University &amp; Research</name>
      <address>
        <city>Wageningen</city>
        <zip>6700 VB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Irritable Bowel Syndrome</keyword>
  <keyword>Quality of Life</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>Undecided</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/NCT03824821
org study id: 18/06
nct id: NCT03824821
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a cross-sectional observational study design that aimed to include 2000 IBS
      patients. We used several validated questionnaires, to assess IBS characteristics (such as
      subtype, severity), psychological features (QoL, anxiety and depression) and assess
      nutritional triggers.

      Subjects filled in the questionnaire online, and was spread across the Netherlands.
observational model: Case-Only
time perspective: Cross-Sectional
measure: IBS subtype
time frame: 1 day (once )
description: Assessed using the Validated Bristol stool chart
measure: IBS severity
time frame: 1 day (once )
description: Assessed by the validated Symptom severity scale (IBS-SSS), rangeing from 0 - 500; 0 very low and 500 very severe case
measure: Nutrition questionnaire
time frame: 1 day (once )
description: We composed a questionnaire containing 44 identified nutritional triggers from literature, and asked subjects if they had (0, no complaints), 1 little complaints, 2 severe complaints, after eating that product.
measure: Birmingham symptom questionnaire
time frame: 1 day (once )
description: Validated questionnaire that assesses symptoms for three domains: pain, diarrhoea and constipation
measure: Irritable bowel syndrome Quality of Life questionnaire
time frame: 1 day (once )
description: We used the validated IBS-QOL which asked 44 questions about quality of life related to IBS. Score ranged from 0 - 100: 100 indicating a very high quality of life, 0 indicating a very poor quality of life
measure: Hospital Anxiety and Depression Score (HADS)
time frame: 1 day (once )
description: We used the validated HADS questionnaire to assess anxiety and depression in IBS patients. This questionnaire gives 2 scores: one for anxiety and depression. Scores range from 0-21, a score above 8 can be referred to as being a case for having anxiety or depression
measure: treatment options currently used
time frame: 1 day (once )
description: We self-composed a questionnaire to assess what type of treatments patients already used, and what their perceived effect was.
measure: Rome IV criteria
time frame: 1 day (once )
description: Validated questions to check whether a subject fits within the profile of IBS
arm group label: IBS
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: IBS
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
sharing ipd: Undecided