<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/NCT02186743</url>
  </required_header>
  <id_info>
    <org_study_id>1404013784</org_study_id>
    <nct_id>NCT02186743</nct_id>
  </id_info>
  <brief_title>Irritable Bowel Syndrome and Food Sensitivity</brief_title>
  <official_title>Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cell Science Systems, Corp.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the clinical trial portion of this study is to assess whether an&#xD;
      individualized dietary plan based on a commercial food sensitivity assay provides specific&#xD;
      benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel group, randomized control trial, powered to assess changes in validated&#xD;
      outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive&#xD;
      dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments&#xD;
      will occur at baseline, 4-weeks, and 8-weeks post-baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants &quot;Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:&quot; Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants &quot;Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:&quot; Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants &quot;Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:&quot; Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Adequate Relief (IBS-AR)</measure>
    <time_frame>Baseline</time_frame>
    <description>The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants &quot;Over the past week have you had adequate relief of your IBS symptoms?&quot; Subjects respond either &quot;yes&quot; or &quot;no.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Adequate Relief (IBS-AR)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants &quot;Over the past week have you had adequate relief of your IBS symptoms?&quot; Subjects respond either &quot;yes&quot; or &quot;no.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Adequate Relief (IBS-AR)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants &quot;Over the past week have you had adequate relief of your IBS symptoms?&quot; Subjects respond either &quot;yes&quot; or &quot;no.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)</measure>
    <time_frame>Baseline</time_frame>
    <description>The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)</measure>
    <time_frame>8 weeks</time_frame>
    <description>The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Intervention Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized Dietary Advice</intervention_name>
    <description>Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.</description>
    <arm_group_label>Active control diet</arm_group_label>
    <arm_group_label>Intervention Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18-70 years of age.&#xD;
&#xD;
          -  Irritable Bowel Syndrome by Rome III criteria.&#xD;
&#xD;
          -  Stable dose (30 days) of concurrent IBS medications&#xD;
&#xD;
          -  Agree not to make significant changes to their diet during the study&#xD;
&#xD;
          -  IBS-SSS score of &gt;150&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of major abdominal surgeries&#xD;
&#xD;
          -  History of inflammatory bowel disease&#xD;
&#xD;
          -  Antibiotic use within 1 month of enrollment&#xD;
&#xD;
          -  Radiation proctitis or other known poorly controlled medical conditions that could&#xD;
             interfere with bowel function&#xD;
&#xD;
          -  Current use of opioid pain medications (except for NSAIDs)&#xD;
&#xD;
          -  Previous experience participating in dietary studies for IBS&#xD;
&#xD;
          -  Current use of medications which are known to be affected by modest dietary changes&#xD;
&#xD;
          -  Vitamin C use of &gt;2000 mg/day&#xD;
&#xD;
          -  Quercetin use of &gt;500 mg/day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ather Ali, ND, MPH, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wajahat Mehal, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://bmjopengastro.bmj.com/content/4/1/e000164</url>
    <description>BMJ Open Gastroenterology</description>
  </link>
  <results_reference>
    <citation>Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast-2017-000164. eCollection 2017.</citation>
    <PMID>29018540</PMID>
  </results_reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irritable Bowel Syndrome</keyword>
  <keyword>IBS</keyword>
  <keyword>Diet</keyword>
  <keyword>Food sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT02186743
org study id: 1404013784
nct id: NCT02186743
lead sponsor: 
collaborator: 
has dmc: Yes
The primary objective of the clinical trial portion of this study is to assess whether an
      individualized dietary plan based on a commercial food sensitivity assay provides specific
      benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).
This is a parallel group, randomized control trial, powered to assess changes in validated
      outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive
      dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments
      will occur at baseline, 4-weeks, and 8-weeks post-baseline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
time frame: Baseline
description: The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
time frame: 4 weeks
description: The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
measure: Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
time frame: 8 weeks
description: The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
time frame: Baseline
description: The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
time frame: 4 weeks
description: The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
measure: Irritable Bowel Syndrome Adequate Relief (IBS-AR)
time frame: 8 weeks
description: The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
time frame: Baseline
description: The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
time frame: 4 weeks
description: The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
measure: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
time frame: 8 weeks
description: The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
time frame: Baseline
description: The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
time frame: 4 weeks
description: The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
measure: Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
time frame: 8 weeks
description: The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
arm group label: Intervention Diet
arm group type: Experimental
description: Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
arm group label: Active control diet
arm group type: Active Comparator
description: Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
intervention type: Other
intervention name: Personalized Dietary Advice
description: Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
arm group label: Active control diet
arm group label: Intervention Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ather Ali, ND, MPH, MHS
role: Principal Investigator
affiliation: Yale University
last name: Wajahat Mehal, MD, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
url: http://bmjopengastro.bmj.com/content/4/1/e000164
description: BMJ Open Gastroenterology
citation: Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast-2017-000164. eCollection 2017.
PMID: 29018540
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Hypersensitivity
mesh term: Syndrome