<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/NCT03035799</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00082222</org_study_id>
    <nct_id>NCT03035799</nct_id>
  </id_info>
  <brief_title>Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms</brief_title>
  <official_title>A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      This pilot study proposes to gain a better understanding of the health benefits of the&#xD;
      popular &quot;paleo-diet&quot; in patients with irritable bowel syndrome (IBS) and explore underlying&#xD;
      mechanisms of benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the proposed study, the primary hypothesis is that, compared with a customary diet,&#xD;
      consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in&#xD;
      patients with irritable bowel syndrome. Investigators also hypothesize consumption of the&#xD;
      Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory&#xD;
      markers, and changes in the gut microbiome and microbiologic profiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2018</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitality</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.&#xD;
GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.&#xD;
PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity level</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal symptoms</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale&#xD;
a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral sensitivity</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall health status (Short Health Scale)</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Overall health status as measured by the Short Health Scale questionnaires. The &quot;Short Health Scale&quot; is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall health status (EQ-5D)</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intestinal permeability</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Change in intestinal permeability as measured by plasma zonulin levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in inflammatory markers</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Change in inflammatory markers as measured by serum C-reactive protein levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in stool metabolomics</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Change in stool metabolomics as measured by stool metabolite testing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in stool microbiome profile</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.</description>
  </other_outcome>
  <other_outcome>
    <measure>Biobank specimen collection of urine.</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies</description>
  </other_outcome>
  <other_outcome>
    <measure>Biobank specimen collection of stool.</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies</description>
  </other_outcome>
  <other_outcome>
    <measure>Biobank specimen collection of saliva.</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies</description>
  </other_outcome>
  <other_outcome>
    <measure>Biobank specimen collection of blood.</measure>
    <time_frame>The change between baseline and 4 weeks (post-intervention).</time_frame>
    <description>Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Paleolithic Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paleolithic Diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General Healthful Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General Healthful Diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paleolithic diet</intervention_name>
    <description>Paleolithic diet</description>
    <arm_group_label>Paleolithic Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General Healthful Diet</intervention_name>
    <description>General Healthful Diet</description>
    <arm_group_label>General Healthful Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate&#xD;
             anxiety or depression&#xD;
&#xD;
          -  Other causes of bowel symptoms excluded to the satisfaction of the Study Team&#xD;
&#xD;
          -  Age at least 18 years at initial screening visit&#xD;
&#xD;
          -  Patients who are able to sign and understand the study's informed consent form&#xD;
&#xD;
          -  Patients able to complete all screening evaluations and procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in inpatient hospital care&#xD;
&#xD;
          -  Severe or refractory bowel or psychological symptoms&#xD;
&#xD;
          -  Current consumption of a Paleolithic diet&#xD;
&#xD;
          -  Known Celiac disease&#xD;
&#xD;
          -  Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone&#xD;
             (TSH) level&#xD;
&#xD;
          -  Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater&#xD;
&#xD;
          -  Patients unable to speak English&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Any condition, which in the opinion of the investigator, would interfere with study&#xD;
             requirements&#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>Pankaj Pasricha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>May 5, 2020</last_update_submitted>
  <last_update_submitted_qc>May 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Undecided</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/NCT03035799
org study id: IRB00082222
nct id: NCT03035799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study proposes to gain a better understanding of the health benefits of the
      popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying
      mechanisms of benefit.
In the proposed study, the primary hypothesis is that, compared with a customary diet,
      consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in
      patients with irritable bowel syndrome. Investigators also hypothesize consumption of the
      Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory
      markers, and changes in the gut microbiome and microbiologic profiles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Vitality
time frame: The change between baseline and 4 weeks (post-intervention).
description: Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.
measure: Anxiety
time frame: The change between baseline and 4 weeks (post-intervention).
description: Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.
GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Depression
time frame: The change between baseline and 4 weeks (post-intervention).
description: Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.
PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Activity level
time frame: The change between baseline and 4 weeks (post-intervention).
description: Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.
measure: Gastrointestinal symptoms
time frame: The change between baseline and 4 weeks (post-intervention).
description: Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale
a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Visceral sensitivity
time frame: The change between baseline and 4 weeks (post-intervention).
description: Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Overall health status (Short Health Scale)
time frame: The change between baseline and 4 weeks (post-intervention).
description: Overall health status as measured by the Short Health Scale questionnaires. The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Overall health status (EQ-5D)
time frame: The change between baseline and 4 weeks (post-intervention).
description: Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.
measure: Intestinal permeability
time frame: The change between baseline and 4 weeks (post-intervention).
description: Change in intestinal permeability as measured by plasma zonulin levels
measure: Change in inflammatory markers
time frame: The change between baseline and 4 weeks (post-intervention).
description: Change in inflammatory markers as measured by serum C-reactive protein levels
measure: Change in stool metabolomics
time frame: The change between baseline and 4 weeks (post-intervention).
description: Change in stool metabolomics as measured by stool metabolite testing.
measure: Change in stool microbiome profile
time frame: The change between baseline and 4 weeks (post-intervention).
description: Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.
measure: Biobank specimen collection of urine.
time frame: The change between baseline and 4 weeks (post-intervention).
description: Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
measure: Biobank specimen collection of stool.
time frame: The change between baseline and 4 weeks (post-intervention).
description: Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
measure: Biobank specimen collection of saliva.
time frame: The change between baseline and 4 weeks (post-intervention).
description: Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
measure: Biobank specimen collection of blood.
time frame: The change between baseline and 4 weeks (post-intervention).
description: Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies
arm group label: Paleolithic Diet
arm group type: Experimental
description: Paleolithic Diet
arm group label: General Healthful Diet
arm group type: Active Comparator
description: General Healthful Diet
intervention type: Other
intervention name: Paleolithic diet
description: Paleolithic diet
arm group label: Paleolithic Diet
intervention type: Other
intervention name: General Healthful Diet
description: General Healthful Diet
arm group label: General Healthful Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pankaj Pasricha, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
sharing ipd: Undecided