<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/NCT03012542</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003247</org_study_id>
    <nct_id>NCT03012542</nct_id>
  </id_info>
  <brief_title>Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease</brief_title>
  <official_title>Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom&#xD;
      control and disease remission. Historically certain diets have been recommended for patients&#xD;
      with Crohn's disease during exacerbations despite lack of data supporting efficacy. The&#xD;
      investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to&#xD;
      moderately active Crohn's disease to one of two diets that differ in the amount and type of&#xD;
      carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated&#xD;
      for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the&#xD;
      microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be&#xD;
      beneficial for Crohn's disease for a period of 8 weeks.&#xD;
&#xD;
      Initial evaluation will include a clinic visit with physical exam, medication review,&#xD;
      supplemental documentation, and labs. Patients will be asked about their food allergies and&#xD;
      intolerances against a master list of all ingredients used in both diets. Patients will then&#xD;
      be provided with instructions on how to record their baseline dietary intake for two weeks&#xD;
      prior to the intervention diet.&#xD;
&#xD;
      At day 0 patients will begin their study diet. All study meals will be provided to the&#xD;
      subject and an approved snack list for the randomized diet will be provided in a sealed&#xD;
      envelope with their first week of meals.&#xD;
&#xD;
      At the conclusion of intervention patients will be asked to resume their previous diet for 4&#xD;
      weeks and record their dietary intake. Stool and blood will be collected at baseline and at&#xD;
      4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were&#xD;
      on and will be provided with dietary consultation by a registered dietitian.&#xD;
&#xD;
      Subjects who withdraw from the study before the 4 week assessment will be asked to provide a&#xD;
      final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week&#xD;
      4, subject replacement will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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>Fecal Calprotectin Remission</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare the proportion of patients with calprotectin remission (fecal calprotectin level &lt; 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal Calprotectin Response</measure>
    <time_frame>8 weeks</time_frame>
    <description>Calprotectin response (decrease by ≥ 100 points) or calprotectin improvement (decrease by &gt; 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Response</measure>
    <time_frame>8 weeks</time_frame>
    <description>Proportion of patients on each diet with clinical response (HBI score decrease by ≥ 3) or remission (HBI score &lt; 5) at weeks 4 and 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metagenomics</measure>
    <time_frame>8 weeks</time_frame>
    <description>To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota correlation with clinical disease activity and inflammatory biomarkers</measure>
    <time_frame>8 weeks</time_frame>
    <description>To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Future Use</measure>
    <time_frame>8 weeks</time_frame>
    <description>To collect stool and blood for potential future analysis looking at proteomics and metabolomics.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Diet 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Diet 1</intervention_name>
    <description>Diet controlled in amount and source of carbohydrates or fiber containing foods.</description>
    <arm_group_label>Diet 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Diet 2</intervention_name>
    <description>Diet controlled in amount and source of carbohydrates or fiber containing foods.</description>
    <arm_group_label>Diet 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consentable adults of age 18 or older.&#xD;
&#xD;
          -  Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history,&#xD;
             physical exam, laboratory/radiological studies, and endoscopy with biopsy.&#xD;
&#xD;
          -  Fecal Calprotectin ≥ 300&#xD;
&#xD;
          -  Mild to moderate disease activity based upon a modified Harvey Bradshaw Index score of&#xD;
             5-16.&#xD;
&#xD;
          -  On stable medication doses for ≥ 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability/unwillingness to adhere to dietary recommendations.&#xD;
&#xD;
          -  Allergy or intolerance to any major component of the diets. Major component defined as&#xD;
             an ingredient which, when left out of intervention diets, may affect study outcomes.&#xD;
&#xD;
          -  Allium intolerance&#xD;
&#xD;
          -  Exclusively vegetarian diet&#xD;
&#xD;
          -  Active intra-abdominal or perianal abscess/fistula&#xD;
&#xD;
          -  Symptomatic bowel stricture&#xD;
&#xD;
          -  Other serious medical conditions such as neurological, liver, kidney, autoimmune, or&#xD;
             systemic disease&#xD;
&#xD;
          -  Use of corticosteroids within 1 month prior to baseline visit&#xD;
&#xD;
          -  Tobacco, alcohol, or illicit drug abuse&#xD;
&#xD;
          -  Pregnant subjects&#xD;
&#xD;
          -  Celiac disease&#xD;
&#xD;
          -  Patients already on one of the diets being studied&#xD;
&#xD;
          -  C. difficile or other enteric infection (O&amp;P, stool enterics)&#xD;
&#xD;
          -  Antibiotic use within 2 months prior to baseline visit&#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>Timothy L Zisman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Timothy L Zisman, MD, MPH</last_name>
    <phone>206-543-3220</phone>
    <email>tzisman@medicine.washington.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christopher J Damman, MD</last_name>
    <phone>206-543-3220</phone>
    <email>cdamman@medicine.washington.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Martin</last_name>
      <phone>206-543-3220</phone>
      <email>amartin@medicine.washington.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.</citation>
    <PMID>21468064</PMID>
  </reference>
  <reference>
    <citation>Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.</citation>
    <PMID>24102340</PMID>
  </reference>
  <reference>
    <citation>Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.</citation>
    <PMID>21885731</PMID>
  </reference>
  <reference>
    <citation>David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.</citation>
    <PMID>24336217</PMID>
  </reference>
  <reference>
    <citation>Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.</citation>
    <PMID>22907164</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>May 12, 2018</last_update_submitted>
  <last_update_submitted_qc>May 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Timothy Zisman</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Requests from investigators will be evaluated on a case by case basis. Data that may be shared include lab values, patient reported outcomes, questionnaires, and microbiome sequences. Specimens may also be shared. Researchers can request data from the study's Principal Investigator in writing.</ipd_description>
  </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/NCT03012542
org study id: STUDY00003247
nct id: NCT03012542
lead sponsor: 
has dmc: No
Recent data suggest that diet in inflammatory bowel disease (IBD) may lead to both symptom
      control and disease remission. Historically certain diets have been recommended for patients
      with Crohn's disease during exacerbations despite lack of data supporting efficacy. The
      investigators propose to evaluate two such diets by randomizing 32 subjects with mildly to
      moderately active Crohn's disease to one of two diets that differ in the amount and type of
      carbohydrates and fiber. Subjects will remain on the diet for 8 weeks and will be evaluated
      for changes from baseline in inflammatory biomarkers, symptomatic disease activity, and the
      microbiome.
Subjects will be randomized in a 1:1 ratio to receive one of two diets that are thought to be
      beneficial for Crohn's disease for a period of 8 weeks.

      Initial evaluation will include a clinic visit with physical exam, medication review,
      supplemental documentation, and labs. Patients will be asked about their food allergies and
      intolerances against a master list of all ingredients used in both diets. Patients will then
      be provided with instructions on how to record their baseline dietary intake for two weeks
      prior to the intervention diet.

      At day 0 patients will begin their study diet. All study meals will be provided to the
      subject and an approved snack list for the randomized diet will be provided in a sealed
      envelope with their first week of meals.

      At the conclusion of intervention patients will be asked to resume their previous diet for 4
      weeks and record their dietary intake. Stool and blood will be collected at baseline and at
      4, 8, and 12 weeks. At the conclusion of the study patients will be told which diet they were
      on and will be provided with dietary consultation by a registered dietitian.

      Subjects who withdraw from the study before the 4 week assessment will be asked to provide a
      final stool sample at the time of withdrawal. If more than 2 subjects drop out prior to week
      4, subject replacement will occur.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fecal Calprotectin Remission
time frame: 8 weeks
description: To compare the proportion of patients with calprotectin remission (fecal calprotectin level < 250 and a decrease by ≥ 100 points) at 8 weeks post-dietary intervention for subjects on each diet
measure: Fecal Calprotectin Response
time frame: 8 weeks
description: Calprotectin response (decrease by ≥ 100 points) or calprotectin improvement (decrease by > 50%) at weeks 4 and 8 for subjects on each diet. Comparison of the mean calprotectin between the 2 treatment groups.
measure: Clinical Response
time frame: 8 weeks
description: Proportion of patients on each diet with clinical response (HBI score decrease by ≥ 3) or remission (HBI score < 5) at weeks 4 and 8
measure: Metagenomics
time frame: 8 weeks
description: To compare changes in the metagenomics of the fecal microbiome at 8 weeks relative to baseline for each diet
measure: Microbiota correlation with clinical disease activity and inflammatory biomarkers
time frame: 8 weeks
description: To determine if changes in the microbiota are associated with changes in clinical disease activity (HBI score), or inflammatory biomarkers (fecal calprotectin, C-reactive protein, etc.).
measure: Future Use
time frame: 8 weeks
description: To collect stool and blood for potential future analysis looking at proteomics and metabolomics.
arm group label: Diet 1
arm group type: Experimental
description: Administered for 8 weeks.
arm group label: Diet 2
arm group type: Experimental
description: Administered for 8 weeks.
intervention type: Dietary Supplement
intervention name: Diet 1
description: Diet controlled in amount and source of carbohydrates or fiber containing foods.
arm group label: Diet 1
intervention type: Dietary Supplement
intervention name: Diet 2
description: Diet controlled in amount and source of carbohydrates or fiber containing foods.
arm group label: Diet 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy L Zisman, MD, MPH
role: Principal Investigator
affiliation: University of Washington
last name: Timothy L Zisman, MD, MPH
phone: 206-543-3220
email: tzisman@medicine.washington.edu
last name: Christopher J Damman, MD
phone: 206-543-3220
email: cdamman@medicine.washington.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Hou JK, Abraham B, El-Serag H. Dietary intake and risk of developing inflammatory bowel disease: a systematic review of the literature. Am J Gastroenterol. 2011 Apr;106(4):563-73. doi: 10.1038/ajg.2011.44.
PMID: 21468064
citation: Richman E, Rhodes JM. Review article: evidence-based dietary advice for patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Nov;38(10):1156-71. doi: 10.1111/apt.12500. Epub 2013 Sep 17.
PMID: 24102340
citation: Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PMID: 21885731
citation: David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PMID: 24336217
citation: Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.
PMID: 22907164
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Timothy Zisman
investigator title: Associate Professor of Medicine
mesh term: Crohn Disease
sharing ipd: Yes
ipd description: Requests from investigators will be evaluated on a case by case basis. Data that may be shared include lab values, patient reported outcomes, questionnaires, and microbiome sequences. Specimens may also be shared. Researchers can request data from the study's Principal Investigator in writing.