<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/NCT02188680</url>
  </required_header>
  <id_info>
    <org_study_id>2013/011/HP</org_study_id>
    <nct_id>NCT02188680</nct_id>
  </id_info>
  <brief_title>Irritable Bowel Syndrome and Low FODMAP Diet</brief_title>
  <acronym>FructIBS</acronym>
  <official_title>Does Irritable Bowel Syndrome Improved by Low FODMAP Diet ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patients having a syndrome SII would be more intolerant in the fructose than the healthy&#xD;
      subjects and would benefit from a fructose diet but also from the fructans which contain some&#xD;
      fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after&#xD;
      absorption of fructose. However, the eviction of the fructose is sometimes recommended to the&#xD;
      patients without having realized beforehand the test of intolerance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to&#xD;
      correlate the results with the respiratory test&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fructose expiration rate (ppm)</measure>
    <time_frame>Day 15</time_frame>
    <description>Estimate the value of the fructose test to predict the efficiency of a diet excluding the fructose and its by-products on the digestive symptoms of the patients having a Syndrome of the irritable bowel.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Low FODMAPS diet and positive breath testing for fructose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with breath testing positive have a low FODMAPS diet. The test will be considered as positive if we observe an increase of more than 20 ppm of H2 and/or CH4 on a sample with regard to the basal concentration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>negative breath testing for fructose</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients with negative breath test have a low FODMAPS diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low FODMAPS diet</intervention_name>
    <description>FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose</description>
    <arm_group_label>Low FODMAPS diet and positive breath testing for fructose</arm_group_label>
    <arm_group_label>negative breath testing for fructose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18, patients with IBS, patients with no organic disorders, patients&#xD;
             informed and agreed to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients&#xD;
             with small intestinal bacterial overgrowth, pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne-Marie LEROI, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne-Marie LEROI, Professor</last_name>
    <phone>02 32 88 80 39</phone>
    <phone_ext>+33</phone_ext>
    <email>anne-marie.leroi@chu-rouen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julien BLOT</last_name>
    <email>julien.blot@chu-rouen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de Physiologie Digestive, Urinaire, Respiratoire et Sportive</name>
      <address>
        <city>Rouen</city>
        <state>Haute Normandie</state>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Marie LEROI, Professor</last_name>
      <phone>02 32 88 80 39</phone>
      <phone_ext>+33</phone_ext>
      <email>anne-marie.leroi@chu-rouen.fr</email>
    </contact>
    <investigator>
      <last_name>Anne-Marie LEROI, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 26, 2013</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>June 13, 2017</last_update_submitted>
  <last_update_submitted_qc>June 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fructose test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02188680
org study id: 2013/011/HP
nct id: NCT02188680
lead sponsor: 
has dmc: No
The patients having a syndrome SII would be more intolerant in the fructose than the healthy
      subjects and would benefit from a fructose diet but also from the fructans which contain some
      fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after
      absorption of fructose. However, the eviction of the fructose is sometimes recommended to the
      patients without having realized beforehand the test of intolerance.
The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to
      correlate the results with the respiratory test
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fructose expiration rate (ppm)
time frame: Day 15
description: Estimate the value of the fructose test to predict the efficiency of a diet excluding the fructose and its by-products on the digestive symptoms of the patients having a Syndrome of the irritable bowel.
arm group label: Low FODMAPS diet and positive breath testing for fructose
arm group type: Active Comparator
description: Patients with breath testing positive have a low FODMAPS diet. The test will be considered as positive if we observe an increase of more than 20 ppm of H2 and/or CH4 on a sample with regard to the basal concentration
arm group label: negative breath testing for fructose
arm group type: Sham Comparator
description: patients with negative breath test have a low FODMAPS diet
intervention type: Other
intervention name: Low FODMAPS diet
description: FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose
arm group label: Low FODMAPS diet and positive breath testing for fructose
arm group label: negative breath testing for fructose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne-Marie LEROI, Professor
role: Principal Investigator
affiliation: University Hospital, Rouen
last name: Anne-Marie LEROI, Professor
phone: 02 32 88 80 39
phone ext: +33
email: anne-marie.leroi@chu-rouen.fr
last name: Julien BLOT
email: julien.blot@chu-rouen.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome