xml: <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/NCT05985018</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 259079: TDA vs. MD in IBS</org_study_id>
      <nct_id>NCT05985018</nct_id>
    </id_info>
    <brief_title>Traditional Dietary Advice Vs. Mediterranean Diet in IBS</brief_title>
    <official_title>A Randomized Trial of Traditional Dietary Advice Versus Mediterranean Diet in Irritable Bowel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Teaching Hospitals NHS Foundation Trust</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>
        Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health&#xD;
        impairment and healthcare utilization. Over 80% of individuals with IBS report food to&#xD;
        trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current&#xD;
        guidelines recommend first-line therapy with the relatively straightforward traditional&#xD;
        dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line&#xD;
        therapy.&#xD;
  &#xD;
        There is emerging data suggesting that the Mediterranean diet may also improve the symptoms&#xD;
        of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to&#xD;
        help position it within the treatment algorithm. Given the relative ease of implementing the&#xD;
        Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits,&#xD;
        studying its efficacy in IBS is attractive as it could potentially pave the way for another&#xD;
        first-line dietary option being available to patients before escalating to the demanding and&#xD;
        resource intensive second-line therapies.&#xD;
  &#xD;
        The investigators will perform a randomized trial comparing the clinical efficacy of&#xD;
        traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization,&#xD;
        participants will complete validated questionnaires to assess changes in IBS symptoms,&#xD;
        quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction&#xD;
        and adherence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in individual items of the IBS-SSS</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>IBS- SSS contains 5 specific questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) with score ranging from 0-100. Change in individual items will be compared within- and between- groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Anxiety and Depression</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>The four-item patient health questionnaire (PHQ-4) for anxiety and depression is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Somatic Symptom reporting</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in quality of life</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>The validated Short form 8 Quality of life Questionnaire assesses quality of life, with higher scores representing better quality of life. Change in scores will be compared within- and between- groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary satisfaction to assigned intervention</measure>
      <time_frame>Week 6</time_frame>
      <description>The Diet Satisfaction Score is a 10-item questionnaire assessing dietary satisfaction to an allocated diet (either Mediterranean diet or traditional diet), with higher scores representing greater satisfaction. Changes in score will be compared between the groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to the Mediterranean diet</measure>
      <time_frame>Week 6</time_frame>
      <description>The 14-point Mediterranean Diet Adherence Screener will check adequate dietary adherence, which we expect will be seen in those assigned a Mediterranean diet compared with traditional diet. Higher scores represent better adherence.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in nutritional intake</measure>
      <time_frame>Baseline to Week 6</time_frame>
      <description>The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups. Only a subset will complete this</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>Traditional Dietary Advice</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mediterranean Diet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional Diet</intervention_name>
      <description>Provided as an educational leaflet</description>
      <arm_group_label>Traditional Dietary Advice</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mediterranean Diet</intervention_name>
      <description>Provided as an educational leaflet</description>
      <arm_group_label>Mediterranean Diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  IBS Symptom Severity Scale(IBS-SSS) &gt; 75&#xD;
  &#xD;
            -  Online access&#xD;
  &#xD;
            -  English literate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac&#xD;
               disease, microscopic colitis, bile acid diarrhoea)&#xD;
  &#xD;
            -  Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)&#xD;
  &#xD;
            -  History of eating disorder&#xD;
  &#xD;
            -  Body mass index &lt;20&#xD;
  &#xD;
            -  Current dietary interventions&#xD;
  &#xD;
            -  Current use of opioids/antibiotics&#xD;
  &#xD;
            -  Titrating dose of neuromodulators&#xD;
  &#xD;
            -  Severe systemic disease (e.g. cardiac, renal, respiratory, psychiatric) necessitating&#xD;
               frequent medical consultations/hospitilisations&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Diabetes mellitus&#xD;
  &#xD;
            -  Scleroderma&#xD;
  &#xD;
            -  Memory impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Imran Aziz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jemima Clarke</last_name>
      <phone>01142265943</phone>
      <email>sth.researchadministration@nhs.net</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</investigator_affiliation>
      <investigator_full_name>Imran Aziz</investigator_full_name>
      <investigator_title>Consultant Gastroenterologist and Senior Lecturer</investigator_title>
    </responsible_party>
    <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>
  
  
text: 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/NCT05985018
  org study id: IRAS 259079: TDA vs. MD in IBS
  nct id: NCT05985018
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Irritable bowel syndrome (IBS) affects 5-10% of the population, and incurs substantial health
        impairment and healthcare utilization. Over 80% of individuals with IBS report food to
        trigger or aggravate symptoms, with many seeking to undertake dietary modifications. Current
        guidelines recommend first-line therapy with the relatively straightforward traditional
        dietary advice, with the more complex and restrictive low FODMAP diet reserved as second-line
        therapy.
  
        There is emerging data suggesting that the Mediterranean diet may also improve the symptoms
        of IBS, although it has not yet been subject to any head-to-head randomized dietary trials to
        help position it within the treatment algorithm. Given the relative ease of implementing the
        Mediterranean diet, alongside its recognized cardio-metabolic and mental health benefits,
        studying its efficacy in IBS is attractive as it could potentially pave the way for another
        first-line dietary option being available to patients before escalating to the demanding and
        resource intensive second-line therapies.
  
        The investigators will perform a randomized trial comparing the clinical efficacy of
        traditional dietary advice vs. a Mediterranean diet in IBS. Following dietary randomization,
        participants will complete validated questionnaires to assess changes in IBS symptoms,
        quality of life, mood, somatic symptoms, nutritional status, as well as dietary satisfaction
        and adherence.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of IBS patients experiencing clinical response with traditional dietary advice vs. Mediterranean diet
  time frame: Baseline to Week 6
  description: IBS symptom severity scale (IBS-SSS) where a 50-point reduction denotes a meaningful clinical response
  measure: Changes in individual items of the IBS-SSS
  time frame: Baseline to Week 6
  description: IBS- SSS contains 5 specific questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) with score ranging from 0-100. Change in individual items will be compared within- and between- groups.
  measure: Changes in Anxiety and Depression
  time frame: Baseline to Week 6
  description: The four-item patient health questionnaire (PHQ-4) for anxiety and depression is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups
  measure: Changes in Somatic Symptom reporting
  time frame: Baseline to Week 6
  description: The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups
  measure: Changes in quality of life
  time frame: Baseline to Week 6
  description: The validated Short form 8 Quality of life Questionnaire assesses quality of life, with higher scores representing better quality of life. Change in scores will be compared within- and between- groups
  measure: Dietary satisfaction to assigned intervention
  time frame: Week 6
  description: The Diet Satisfaction Score is a 10-item questionnaire assessing dietary satisfaction to an allocated diet (either Mediterranean diet or traditional diet), with higher scores representing greater satisfaction. Changes in score will be compared between the groups.
  measure: Adherence to the Mediterranean diet
  time frame: Week 6
  description: The 14-point Mediterranean Diet Adherence Screener will check adequate dietary adherence, which we expect will be seen in those assigned a Mediterranean diet compared with traditional diet. Higher scores represent better adherence.
  measure: Changes in nutritional intake
  time frame: Baseline to Week 6
  description: The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups. Only a subset will complete this
  arm group label: Traditional Dietary Advice
  arm group type: Active Comparator
  description: Its main elements are to adopt sensible eating habits and avoid excess fatty foods, spicy foods, processed foods, caffeine, fizzy drinks and alcohol.
  arm group label: Mediterranean Diet
  arm group type: Active Comparator
  description: The principle components is a diet rich in vegetables, pulses, whole grains, and olive oil
  intervention type: Other
  intervention name: Traditional Diet
  description: Provided as an educational leaflet
  arm group label: Traditional Dietary Advice
  intervention type: Other
  intervention name: Mediterranean Diet
  description: Provided as an educational leaflet
  arm group label: Mediterranean Diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Imran Aziz
  role: Principal Investigator
  affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
  last name: Jemima Clarke
  phone: 01142265943
  email: sth.researchadministration@nhs.net
  responsible party type: Principal Investigator
  investigator affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
  investigator full name: Imran Aziz
  investigator title: Consultant Gastroenterologist and Senior Lecturer
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome
  sharing ipd: No