<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/NCT02970591</url>
  </required_header>
  <id_info>
    <org_study_id>Car-IBS 1511-01</org_study_id>
    <nct_id>NCT02970591</nct_id>
  </id_info>
  <brief_title>A Comparison of Three Different Treatment Options for Irritable Bowel Syndrome</brief_title>
  <acronym>CARIBS</acronym>
  <official_title>The Role of CARbohydrates in Irritable Bowel Syndrome (CARIBS): Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <brief_summary>
    <textblock>
      Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is&#xD;
      considered to trigger symptoms associated with the clinical picture of IBS, and dietary&#xD;
      treatment is thus believed to relieve the symptoms of IBS. As the disease is very&#xD;
      heterogeneous in its manifestation, different treatment options might be indicated depending&#xD;
      on the predominant symptom. To investigate the response to different dietary treatment&#xD;
      options, a randomized controlled intervention trial will be carried out in adult patients&#xD;
      (&gt;18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the&#xD;
      response to two different dietary treatments or optimized medical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized controlled trial comparing three different treatments during four&#xD;
      weeks:&#xD;
&#xD;
        1. Combination of low FODMAP diet + traditional dietary advice (based on NICE&#xD;
           recommendations)&#xD;
&#xD;
             -  Eat at regular hours; 3 main meals and 3 snacks&#xD;
&#xD;
             -  Eat in peace, chew the food properly&#xD;
&#xD;
             -  Peel all fruits and vegetables&#xD;
&#xD;
             -  Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and&#xD;
                chewing gum&#xD;
&#xD;
             -  Choose soluble rather than insoluble fibres&#xD;
&#xD;
             -  Avoid foods high in FODMAPs&#xD;
&#xD;
        2. Diet low in carbohydrates&#xD;
&#xD;
             -  10 E% carbohydrates, 23 E% protein, 67 E% fat&#xD;
&#xD;
             -  Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if&#xD;
                wanted) nuts, seeds, oil, vegetables&#xD;
&#xD;
             -  No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits&#xD;
&#xD;
             -  No specific consideration about FODMAP content&#xD;
&#xD;
        3. Optimized pharmacological tretament based on predominant symptom and previous experience&#xD;
           with pharmacological treatmment.&#xD;
&#xD;
      Pain/discomfort:&#xD;
&#xD;
        -  Pain: Amitriptyline 25 mg. Increase to 50 mg if needed&#xD;
&#xD;
        -  Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed&#xD;
&#xD;
        -  Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed&#xD;
&#xD;
        -  Pain with constipation: Linaclotide 290 microgram 1x1&#xD;
&#xD;
      Constipation:&#xD;
&#xD;
        -  Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed&#xD;
&#xD;
        -  Osmotic laxative (Macrogol (Movicol) 1x1&#xD;
&#xD;
        -  Linaclotide 290 microgram 1x1 Diarrhea&#xD;
&#xD;
        -  Loperamide 1x2 . Adjust dose if needed&#xD;
&#xD;
        -  Cholestyramine 1x1. Increase ever 3-5 d as needed&#xD;
&#xD;
        -  Ondansetron 4mg 1x1. Increase to 1x2-3 if needed&#xD;
&#xD;
        -  Eluxadoline 100mg 1x2&#xD;
&#xD;
      Primary endpoint: IBS-SSS reduction &gt;50 points&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">April 29, 2022</completion_date>
  <primary_completion_date type="Actual">April 15, 2022</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion (%) of patients who respond to treatment</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>A responder is defined as having an IBS-SSS reduction &gt;50 points @ 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in symptom severity</measure>
    <time_frame>Baseline, 4 weeks, 3 and 6 months</time_frame>
    <description>Absolute and percentage change in IBS-SSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determinants for GI symptoms by IBS-SSS</measure>
    <time_frame>Baseline, 4 weeks, 3 and 6 months</time_frame>
    <description>GI symptoms measured by IBS-SSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determinants for GI symptoms by GSRS-IBS</measure>
    <time_frame>Baseline, 4 weeks, 3 and 6 months</time_frame>
    <description>GI symptoms measured by GSRS-IBS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictors of response to treatment</measure>
    <time_frame>Baseline to 4 weeks</time_frame>
    <description>Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to allocated intervention</measure>
    <time_frame>Baseline, 4 weeks, 3 and 6 months</time_frame>
    <description>Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiota content</measure>
    <time_frame>Baseline, 4 weeks, 6 months</time_frame>
    <description>Fecal microbiota analysis using 16S technique</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in extra-intestinal symptoms and quality of life</measure>
    <time_frame>Baseline, 4 weeks, 3 and 6 months</time_frame>
    <description>As assessed by IBS specific questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in metabolic profile</measure>
    <time_frame>Baseline, 4 weeks, 6 months</time_frame>
    <description>Metabolomics in serum and urine samples</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Qualitative assessment</measure>
    <time_frame>Approx. at 3 months follow-up</time_frame>
    <description>Patient's subjective experiences related to the dietary intervention described by qualitative methods.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Diet A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low carbohydrate diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Optimized Medical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional dietary advice and low FODMAP content</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional dietary advice and low FODMAP content</intervention_name>
    <description>Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.</description>
    <arm_group_label>Diet A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low carbohydrate diet</intervention_name>
    <description>Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.</description>
    <arm_group_label>Diet B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optimized Medical treatment</intervention_name>
    <description>Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.</description>
    <arm_group_label>Medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IBS according to ROME IV criteria, BMI 18-35, ability to communicate in Swedish,&#xD;
             Gothenburg region resident&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart, liver, neurologic or psychiatric disease or illness&#xD;
&#xD;
          -  Serious gastrointestinal diseases&#xD;
&#xD;
          -  Celiac disease&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Other conditions or surgery that affects the gastrointestinal function&#xD;
&#xD;
          -  Hyperlipidemia&#xD;
&#xD;
          -  Food allergy or intolerance other than lactose&#xD;
&#xD;
          -  Adherence to a specific diet&#xD;
&#xD;
          -  Being pregnant or breastfeeding&#xD;
&#xD;
          -  Previously been treated with any of the intervention arms, including having tested all&#xD;
             of the pharmacological treatment options of relevance for the symptom profile of the&#xD;
             patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Magnus Simren</name>
      <address>
        <city>Gothenburg</city>
        <state>Non-US/Non-Canadian</state>
        <zip>44331</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Magnus Simrén</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>FODMAPS</keyword>
  <keyword>carbohydrates</keyword>
  <keyword>metabolomics</keyword>
  <keyword>microbiota</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>
  <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/NCT02970591
org study id: Car-IBS 1511-01
nct id: NCT02970591
lead sponsor: 
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is
      considered to trigger symptoms associated with the clinical picture of IBS, and dietary
      treatment is thus believed to relieve the symptoms of IBS. As the disease is very
      heterogeneous in its manifestation, different treatment options might be indicated depending
      on the predominant symptom. To investigate the response to different dietary treatment
      options, a randomized controlled intervention trial will be carried out in adult patients
      (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the
      response to two different dietary treatments or optimized medical treatment.
The study is a randomized controlled trial comparing three different treatments during four
      weeks:

        1. Combination of low FODMAP diet + traditional dietary advice (based on NICE
           recommendations)

             -  Eat at regular hours; 3 main meals and 3 snacks

             -  Eat in peace, chew the food properly

             -  Peel all fruits and vegetables

             -  Limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and
                chewing gum

             -  Choose soluble rather than insoluble fibres

             -  Avoid foods high in FODMAPs

        2. Diet low in carbohydrates

             -  10 E% carbohydrates, 23 E% protein, 67 E% fat

             -  Larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if
                wanted) nuts, seeds, oil, vegetables

             -  No sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits

             -  No specific consideration about FODMAP content

        3. Optimized pharmacological tretament based on predominant symptom and previous experience
           with pharmacological treatmment.

      Pain/discomfort:

        -  Pain: Amitriptyline 25 mg. Increase to 50 mg if needed

        -  Episodic pain: Hyoscyamine 0,2mg 2x2; adjust dose if needed

        -  Pain with diarrhea: Amitriptyline 25 mg. Increase dose if needed

        -  Pain with constipation: Linaclotide 290 microgram 1x1

      Constipation:

        -  Bulking agent (Sterculia gum (Inolaxol) 1x1. Increase to 1x3 if needed

        -  Osmotic laxative (Macrogol (Movicol) 1x1

        -  Linaclotide 290 microgram 1x1 Diarrhea

        -  Loperamide 1x2 . Adjust dose if needed

        -  Cholestyramine 1x1. Increase ever 3-5 d as needed

        -  Ondansetron 4mg 1x1. Increase to 1x2-3 if needed

        -  Eluxadoline 100mg 1x2

      Primary endpoint: IBS-SSS reduction >50 points
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: The proportion (%) of patients who respond to treatment
time frame: Baseline to 4 weeks
description: A responder is defined as having an IBS-SSS reduction >50 points @ 4 weeks
measure: Change in symptom severity
time frame: Baseline, 4 weeks, 3 and 6 months
description: Absolute and percentage change in IBS-SSS
measure: Determinants for GI symptoms by IBS-SSS
time frame: Baseline, 4 weeks, 3 and 6 months
description: GI symptoms measured by IBS-SSS
measure: Determinants for GI symptoms by GSRS-IBS
time frame: Baseline, 4 weeks, 3 and 6 months
description: GI symptoms measured by GSRS-IBS
measure: Predictors of response to treatment
time frame: Baseline to 4 weeks
description: Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology
measure: Adherence to allocated intervention
time frame: Baseline, 4 weeks, 3 and 6 months
description: Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up
measure: Change in microbiota content
time frame: Baseline, 4 weeks, 6 months
description: Fecal microbiota analysis using 16S technique
measure: Change in extra-intestinal symptoms and quality of life
time frame: Baseline, 4 weeks, 3 and 6 months
description: As assessed by IBS specific questionnaires
measure: Change in metabolic profile
time frame: Baseline, 4 weeks, 6 months
description: Metabolomics in serum and urine samples
measure: Qualitative assessment
time frame: Approx. at 3 months follow-up
description: Patient's subjective experiences related to the dietary intervention described by qualitative methods.
arm group label: Diet A
arm group type: Experimental
description: Low carbohydrate diet
arm group label: Medical treatment
arm group type: Active Comparator
description: Optimized Medical treatment
arm group label: Diet B
arm group type: Experimental
description: Traditional dietary advice and low FODMAP content
intervention type: Other
intervention name: Traditional dietary advice and low FODMAP content
description: Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
arm group label: Diet A
intervention type: Other
intervention name: Low carbohydrate diet
description: Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
arm group label: Diet B
intervention type: Other
intervention name: Optimized Medical treatment
description: Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.
arm group label: Medical treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Magnus Simrén
investigator title: Professor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: No