<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/NCT03306381</url>
  </required_header>
  <id_info>
    <org_study_id>IBS-2017</org_study_id>
    <nct_id>NCT03306381</nct_id>
  </id_info>
  <brief_title>The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS</brief_title>
  <official_title>The Effect of Dietary Intervention on Symptoms in Relation to Genetical Characteristics, Epigenetics, Gut Microbiota, and Autoantibodies in IBS Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to research whether subjects with irritable bowel syndrome&#xD;
      (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control&#xD;
      group. Further, we will investigate if these parameters as well as subjective IBS symptoms&#xD;
      are affected by a 4-week long dietary intervention within the IBS patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be performed on 140 subjects with verified IBS. Patients will be recruited&#xD;
      from the clinic of Gastroenterology or Internal medicine as well as primary health care&#xD;
      centers. At the start of the study patients will fill out protocols concerning Rom IV&#xD;
      criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales.&#xD;
      They will be examined by a physician/researcher who will complete protocols of clinical data.&#xD;
      Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals&#xD;
      will go through the same procedure as described above.&#xD;
&#xD;
      Study participants with IBS will thereafter be randomized to receive an alternative diet&#xD;
      resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130),&#xD;
      or to continue with their regular diet (control group; n=20). After 4 weeks of dietary&#xD;
      intervention, there will be a follow-up where blood and fecal samples are once again&#xD;
      collected. At this point in time, participants will also fill in IBS symptom rating scales&#xD;
      again.&#xD;
&#xD;
      Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide&#xD;
      association studies), gut microbiota and inflammatory parameter analyses.&#xD;
&#xD;
      Statistics&#xD;
&#xD;
      To study differences in the above-mentioned parameters between patients and controls as well&#xD;
      as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used,&#xD;
      respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic variation of enzymes regulating absorption of disaccharides</measure>
    <time_frame>measured at baseline</time_frame>
    <description>Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes from baseline in subjective symptoms according to the IBS-SSS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes from baseline in subjective symptoms according to the VAS-IBS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut microbiota composition</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes from baseline in fecal microbiota analysed by 16rs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microRNA expression</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes from baseline in microRNA expression will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>IBS - Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Dietary intervention subject group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>n=130. Participants on low FODMAP-similar diet during 4-week study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>n=20. Participants on traditional IBS diet during 4-week study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>Elimination of certain products.</description>
    <arm_group_label>Dietary intervention subject group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Verified IBS according to Rom IV criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious mental or somatic disease&#xD;
&#xD;
          -  Abuse&#xD;
&#xD;
          -  Inability to understand he Swedish language&#xD;
&#xD;
          -  Already on a diet (e.g. vegan, FODMAP, gluten-free).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bodil Ohlsson, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skane</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deartment of INternal Medicine</name>
      <address>
        <city>Malmö</city>
        <zip>20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IBS</keyword>
  <keyword>Epigenetics</keyword>
  <keyword>Dietary intervention</keyword>
  <keyword>Gut Microbiota</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Genetics</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/NCT03306381
org study id: IBS-2017
nct id: NCT03306381
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to research whether subjects with irritable bowel syndrome
      (IBS) display epigenetic/genetic changes or altered microbiota compared to a non-IBS control
      group. Further, we will investigate if these parameters as well as subjective IBS symptoms
      are affected by a 4-week long dietary intervention within the IBS patient group.
The study will be performed on 140 subjects with verified IBS. Patients will be recruited
      from the clinic of Gastroenterology or Internal medicine as well as primary health care
      centers. At the start of the study patients will fill out protocols concerning Rom IV
      criteria (to validate that IBS criteria are filled) as well as IBS symptom rating scales.
      They will be examined by a physician/researcher who will complete protocols of clinical data.
      Blood and fecal samples will be collected. A control group of healthy, non-IBS individuals
      will go through the same procedure as described above.

      Study participants with IBS will thereafter be randomized to receive an alternative diet
      resembling the FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=130),
      or to continue with their regular diet (control group; n=20). After 4 weeks of dietary
      intervention, there will be a follow-up where blood and fecal samples are once again
      collected. At this point in time, participants will also fill in IBS symptom rating scales
      again.

      Samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide
      association studies), gut microbiota and inflammatory parameter analyses.

      Statistics

      To study differences in the above-mentioned parameters between patients and controls as well
      as before and after dietary intervention, Mann-Whitney U-test and Wilcoxon test will be used,
      respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Genetic variation of enzymes regulating absorption of disaccharides
time frame: measured at baseline
description: Genetic expression of disaccharide-degradating enzymes will be measured at baseline and related to the response of study participants to dietary intervention.
measure: Irritable bowel syndrome-subjective severity scores (IBS-SSS) ratings
time frame: 4 weeks
description: Changes from baseline in subjective symptoms according to the IBS-SSS.
measure: Visual analog scale for irritable bowel syndrome (VAS-IBS) ratings
time frame: 4 weeks
description: Changes from baseline in subjective symptoms according to the VAS-IBS.
measure: Gut microbiota composition
time frame: 4 weeks
description: Changes from baseline in fecal microbiota analysed by 16rs
measure: Cytokines
time frame: 4 weeks
description: Changes from baseline in cytokine plasma concentrations will be assessed by ELISA.
measure: microRNA expression
time frame: 4 weeks
description: Changes from baseline in microRNA expression will be assessed.
arm group label: Dietary intervention subject group
arm group type: Experimental
description: n=130. Participants on low FODMAP-similar diet during 4-week study period.
arm group label: Control group
arm group type: No Intervention
description: n=20. Participants on traditional IBS diet during 4-week study period.
intervention type: Other
intervention name: Dietary intervention
description: Elimination of certain products.
arm group label: Dietary intervention subject group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bodil Ohlsson, MD, PhD
role: Principal Investigator
affiliation: Region Skane
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
sharing ipd: No