<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/NCT04401605</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 55558</org_study_id>
    <nct_id>NCT04401605</nct_id>
  </id_info>
  <brief_title>Fermented Food-Supplemented Diet in Ulcerative Colitis</brief_title>
  <official_title>Effects of a Fermented Food-Supplemented on Patients With Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford 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>
      The purpose of this study is to see how a diet that supplements fermented foods effects&#xD;
      inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC).&#xD;
      There is a paucity of research and an enormous need for better understanding of diet and&#xD;
      intestinal inflammation. Fermented food have been shown to positively influence inflammatory&#xD;
      cytokines and intestinal microbial diversity in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 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>Change in the clinical disease activity inflammatory marker fecal calprotectin</measure>
    <time_frame>Baseline (Data Collection 1) versus Week 10 (Data Collection 2).</time_frame>
    <description>Change in fecal calprotectin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response as per partial Mayo score.</measure>
    <time_frame>Baseline (Data Collection 1) versus Week 10 (Data Collection 2).</time_frame>
    <description>Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of &gt;=2 points and either a rectal bleeding subscore of &lt;=1 or a decrease in the rectal bleeding subscore of &gt;=1 point (assessed at Data Collection 2). The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical remission as per partial Mayo score.</measure>
    <time_frame>Assessed at Week 10 (Data Collection 2).</time_frame>
    <description>Clinical remission as per partial Mayo score is defined as a partial Mayo score &lt; 2 points and no individual subscale score &gt;1 point (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic remission as per Patient Reported Outcome (PRO2) score</measure>
    <time_frame>Assessed at Week 10 (Data Collection 2).</time_frame>
    <description>Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient global assessment</measure>
    <time_frame>Assessed at Week 10 (Data Collection 2).</time_frame>
    <description>&quot;Do you believe you are in remission from your UC symptoms?&quot; (Yes/No)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Fermented Food-Supplemented Diet on patient quality of life</measure>
    <time_frame>Baseline (Data Collection 1) versus Week 10 (Data Collection 2).</time_frame>
    <description>Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cytokines/chemokines and immune cell profiles</measure>
    <time_frame>Baseline (Data Collection 1) versus Week 10 (Data Collection 2).</time_frame>
    <description>Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in gut microbiome profiles</measure>
    <time_frame>Baseline (Data Collection 1) versus Week 10 (Data Collection 2).</time_frame>
    <description>Gut microbiome profiles</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Diet Modification</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Fermented Food-Supplemented Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Diet Control Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fermented Food-supplemented Diet</intervention_name>
    <description>Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.</description>
    <arm_group_label>Fermented Food-Supplemented Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular Diet</intervention_name>
    <description>No change in diet.</description>
    <arm_group_label>Regular Diet Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Male or female subjects, ≥18 years of age&#xD;
&#xD;
          -  Confirmed diagnosis of UC&#xD;
&#xD;
          -  Symptomatic disease defined as partial Mayo Score 2 to 7 (inclusive)&#xD;
&#xD;
          -  Elevated fecal calprotectin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, nursing or expect to be pregnant&#xD;
&#xD;
          -  Intolerance to fermented food&#xD;
&#xD;
          -  Individuals with a body mass index (BMI) lower than 18&#xD;
&#xD;
          -  Individuals diagnosed with a serious medical condition (unless approved in writing by&#xD;
             a physician)&#xD;
&#xD;
          -  Individuals who have been severely weakened by a disease or medical procedure&#xD;
&#xD;
          -  Individuals with more than mild-moderate cardiovascular disease or life-threatening&#xD;
             cancer (as determined by patient's physician) unless approved by a physician&#xD;
&#xD;
          -  Individuals with history of severe cardiac disease (particularly uncompensated&#xD;
             congestive heart failure NYHA grade 2 or more or LVEF &lt; 40%)&#xD;
&#xD;
          -  History of relevant intestinal surgery such as total or hemi-colectomy,&#xD;
             proctocolectomy, stoma.&#xD;
&#xD;
        Complications of disease such as extraintestinal manifestations (EIMs) are not&#xD;
        automatically considered exclusion criteria. Appropriate medical treatment for UC and/or&#xD;
        EIMs will not be withheld.&#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>Sidhartha Sinha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Touran Fardeen</last_name>
    <phone>6507367311</phone>
    <email>tfardeen@stanford.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Touran Fardeen</last_name>
      <email>tfardeen@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Sidhartha Ranjit Sinha</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine (Gastroenterology and Hepatology)</investigator_title>
  </responsible_party>
  <keyword>IBD</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>UC</keyword>
  <keyword>Diet</keyword>
  <keyword>Fermented Food</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Ulcer</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/NCT04401605
org study id: IRB 55558
nct id: NCT04401605
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see how a diet that supplements fermented foods effects
      inflammation and quality of life in patients with mild to moderate Ulcerative Colitis (UC).
      There is a paucity of research and an enormous need for better understanding of diet and
      intestinal inflammation. Fermented food have been shown to positively influence inflammatory
      cytokines and intestinal microbial diversity in healthy volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the clinical disease activity inflammatory marker fecal calprotectin
time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
description: Change in fecal calprotectin
measure: Clinical response as per partial Mayo score.
time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
description: Clinical response as per partial Mayo score is defined as a decrease from baseline in the partial Mayo Score of >=2 points and either a rectal bleeding subscore of <=1 or a decrease in the rectal bleeding subscore of >=1 point (assessed at Data Collection 2). The partial Mayo score consists of the subscores for stool frequency, rectal bleeding, and PGA, omitting endoscopy. Each subscore is graded from 0 to 3 (3 being the worst situation and 0 the best) and the partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
measure: Clinical remission as per partial Mayo score.
time frame: Assessed at Week 10 (Data Collection 2).
description: Clinical remission as per partial Mayo score is defined as a partial Mayo score < 2 points and no individual subscale score >1 point (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
measure: Symptomatic remission as per Patient Reported Outcome (PRO2) score
time frame: Assessed at Week 10 (Data Collection 2).
description: Symptomatic remission is defined as as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0 (assessed at Data Collection 2). The partial Mayo score is graded from 0 to 9 (0 being the best, 9 being the worst outcome).
measure: Patient global assessment
time frame: Assessed at Week 10 (Data Collection 2).
description: "Do you believe you are in remission from your UC symptoms?" (Yes/No)
measure: Effect of Fermented Food-Supplemented Diet on patient quality of life
time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
description: Change in Short Inflammatory Bowel Disease questionnaire (SIBDQ) score. The SIBDQ is a quality of life score in UC patients. Response to each of the questions is graded from 1 to 7 (1 being the worst situation and 7 the best).
measure: Changes in cytokines/chemokines and immune cell profiles
time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
description: Cytokines/chemokines (e.g. TNF-alpha, IL-6, IL-10, IFN-gamma, α4β7, CCR1, and CCR9) and immune cell profiles.
measure: Changes in gut microbiome profiles
time frame: Baseline (Data Collection 1) versus Week 10 (Data Collection 2).
description: Gut microbiome profiles
arm group label: Fermented Food-Supplemented Diet
arm group type: Experimental
description: Patients in this arm will supplement their regular diet by an increasing number of daily servings of fermented food over a period of 10 weeks.
arm group label: Regular Diet Control Arm
arm group type: Placebo Comparator
description: Patients in this arm will continue their regular diet throughout the 10 weeks of study with a maximum of 1 serving of fermented foods per day.
intervention type: Other
intervention name: Fermented Food-supplemented Diet
description: Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
arm group label: Fermented Food-Supplemented Diet
intervention type: Other
intervention name: Regular Diet
description: No change in diet.
arm group label: Regular Diet Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sidhartha Sinha, MD
role: Principal Investigator
affiliation: Stanford University
last name: Touran Fardeen
phone: 6507367311
email: tfardeen@stanford.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Sidhartha Ranjit Sinha
investigator title: Assistant Professor of Medicine (Gastroenterology and Hepatology)
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Inflammatory Bowel Diseases
mesh term: Ulcer