<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/NCT04505410</url>
  </required_header>
  <id_info>
    <org_study_id>20200436</org_study_id>
    <nct_id>NCT04505410</nct_id>
  </id_info>
  <brief_title>Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis</brief_title>
  <official_title>A Randomized Control Study to Examine the Influence of a Healthy Diet on Moderate to Severe Ulcerative Colitis Patients Undergoing Second Line Induction With Biological Medications Tofacitinib, Ustekinumab or Vedolizumab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking&#xD;
      diet) will help induce clinical and biochemical response to tofacitinib therapy or second&#xD;
      line biologic therapy with ustekinumab or infliximab in patients with ulcerative colitis.&#xD;
      Study period will be 8 weeks during induction of tofacitinib or ustekinumab or infliximab.&#xD;
      The primary aims of this study are to determine clinical response and improvement in fecal&#xD;
      calprotectin and C-reactive protein levels. Secondary outcomes will include assessment of&#xD;
      changes in the stool microbiome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 18, 2020</start_date>
  <completion_date type="Anticipated">October 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
  <phase>Phase 3</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients who achieved clinical response</measure>
    <time_frame>8 weeks</time_frame>
    <description>Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥2 points from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fecal Calprotectin levels</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>Calprotectin levels will be evaluated using fecal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CRP levels</measure>
    <time_frame>baseline, 8 weeks</time_frame>
    <description>C-Reactive Protein (CRP) levels will be evaluated using blood samples</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Tofacitinib plus FMD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tofacitinib only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infliximab plus FMD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with infliximab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infliximab only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with infliximab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ustekinumab plus FMD group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with ustekinumab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ustekinumab only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with ustekinumab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib</intervention_name>
    <description>10mg tofacitinib tablets taken twice daily for eight weeks</description>
    <arm_group_label>Tofacitinib only group</arm_group_label>
    <arm_group_label>Tofacitinib plus FMD group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast Mimicking Diet</intervention_name>
    <description>FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.</description>
    <arm_group_label>Infliximab plus FMD group</arm_group_label>
    <arm_group_label>Tofacitinib plus FMD group</arm_group_label>
    <arm_group_label>Ustekinumab plus FMD group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab induction</intervention_name>
    <description>Participant will be initiated with ustekinumab induction therapy as second line biologic therapy</description>
    <arm_group_label>Ustekinumab only</arm_group_label>
    <arm_group_label>Ustekinumab plus FMD group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Infliximab induction</intervention_name>
    <description>Participant will be initiated with infliximab induction therapy as second line biologic therapy</description>
    <arm_group_label>Infliximab only</arm_group_label>
    <arm_group_label>Infliximab plus FMD group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with ulcerative colitis who are beginning tofacitinib therapy.&#xD;
&#xD;
          2. Patients with ulcerative colitis who are initiating second line biologic therapy with&#xD;
             ustekinumab&#xD;
&#xD;
          3. Patients with ulcerative colitis who are initiating second line biologic therapy with&#xD;
             infliximab&#xD;
&#xD;
          4. Patients aged 18 years or older.&#xD;
&#xD;
          5. Patients with active disease defined as simple clinical colitis activity index (SCCAI)&#xD;
             &gt;2&#xD;
&#xD;
          6. Patients who have not been on antibiotics for 2 weeks or probiotics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than 18 years.&#xD;
&#xD;
          2. Patients that do not meet the inclusion criteria specified above.&#xD;
&#xD;
          3. Patients with clinical signs of fulminant colitis, toxic megacolon, ischemic colitis&#xD;
             or impending hospitalization for severe ulcerative colitis.&#xD;
&#xD;
          4. Patients with concomitant infectious colitis.&#xD;
&#xD;
          5. Patients allergic nuts/soy/sesame/oats.&#xD;
&#xD;
          6. Patients who do not like the food items that form part of the kits for the fasting&#xD;
             mimicking diet (see below).&#xD;
&#xD;
          7. Patients that are diabetics on a glucose lowering drug.&#xD;
&#xD;
          8. Individuals with a history of syncope/presyncope with fasting or from medical&#xD;
             conditions.&#xD;
&#xD;
          9. Women who are pregnant or nursing.&#xD;
&#xD;
         10. Individuals with very low BMI&lt; or equal to 18.&#xD;
&#xD;
         11. Patients with the following comorbidities: chronic kidney disease, diabetes, active&#xD;
             cancer.&#xD;
&#xD;
         12. Prohibited concomitant therapies will include TNF antagonists, azathioprine,&#xD;
             methotrexate, and mercaptopurine.&#xD;
&#xD;
         13. Patients who routinely have fasting eating habits&#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>Oriana Damas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriella Grau, BS</last_name>
    <phone>305-243-6405</phone>
    <email>g.grau@miami.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriella Grau, BS</last_name>
      <phone>305-243-6405</phone>
      <email>g.grau@miami.edu</email>
    </contact>
    <investigator>
      <last_name>Oriana Damas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gastro Health</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gabriella Grau</last_name>
      <phone>305-243-6405</phone>
      <email>g.grau@miami.edu</email>
    </contact>
    <investigator>
      <last_name>Oriana Damas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Oriana Mazorra Damas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infliximab</mesh_term>
    <mesh_term>Ustekinumab</mesh_term>
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_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/NCT04505410
org study id: 20200436
nct id: NCT04505410
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking
      diet) will help induce clinical and biochemical response to tofacitinib therapy or second
      line biologic therapy with ustekinumab or infliximab in patients with ulcerative colitis.
      Study period will be 8 weeks during induction of tofacitinib or ustekinumab or infliximab.
      The primary aims of this study are to determine clinical response and improvement in fecal
      calprotectin and C-reactive protein levels. Secondary outcomes will include assessment of
      changes in the stool microbiome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of patients who achieved clinical response
time frame: 8 weeks
description: Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥2 points from baseline.
measure: Change in Fecal Calprotectin levels
time frame: baseline, 8 weeks
description: Calprotectin levels will be evaluated using fecal samples
measure: Change in CRP levels
time frame: baseline, 8 weeks
description: C-Reactive Protein (CRP) levels will be evaluated using blood samples
arm group label: Tofacitinib plus FMD group
arm group type: Experimental
description: Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
arm group label: Tofacitinib only group
arm group type: Active Comparator
description: Participants in this group with UC consuming a standard, regular low-fiber diet will be provided Tofacitinib for eight consecutive weeks.
arm group label: Infliximab plus FMD group
arm group type: Experimental
description: Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with infliximab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
arm group label: Infliximab only
arm group type: Active Comparator
description: Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with infliximab
arm group label: Ustekinumab plus FMD group
arm group type: Experimental
description: Participants in this group with UC consuming a standard, regular low-fiber diet and will have initiated second line biologic therapy with ustekinumab with the addition of two, five-day cycles of Fast Mimicking Diet (FMD) daily meals on weeks 2 and 6.
arm group label: Ustekinumab only
arm group type: Active Comparator
description: Participants in this group with UC consuming a standard, regular low-fiber diet for 8 consecutive weeks and will have initiated second line biologic therapy with ustekinumab
intervention type: Drug
intervention name: Tofacitinib
description: 10mg tofacitinib tablets taken twice daily for eight weeks
arm group label: Tofacitinib only group
arm group label: Tofacitinib plus FMD group
intervention type: Other
intervention name: Fast Mimicking Diet
description: FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
arm group label: Infliximab plus FMD group
arm group label: Tofacitinib plus FMD group
arm group label: Ustekinumab plus FMD group
intervention type: Drug
intervention name: Ustekinumab induction
description: Participant will be initiated with ustekinumab induction therapy as second line biologic therapy
arm group label: Ustekinumab only
arm group label: Ustekinumab plus FMD group
intervention type: Drug
intervention name: Infliximab induction
description: Participant will be initiated with infliximab induction therapy as second line biologic therapy
arm group label: Infliximab only
arm group label: Infliximab plus FMD group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oriana Damas, MD
role: Principal Investigator
affiliation: University of Miami
last name: Gabriella Grau, BS
phone: 305-243-6405
email: g.grau@miami.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Oriana Mazorra Damas
investigator title: Assistant Professor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
mesh term: Infliximab
mesh term: Ustekinumab
mesh term: Tofacitinib
sharing ipd: No