<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/NCT03833596</url>
  </required_header>
  <id_info>
    <org_study_id>EEN in Crohn</org_study_id>
    <nct_id>NCT03833596</nct_id>
  </id_info>
  <brief_title>Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD)</brief_title>
  <acronym>EENCD</acronym>
  <official_title>Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</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>
      This study evaluates the effect of Exclusive Enteral Nutrition (EEN) in addition to different&#xD;
      regimes of corticosteroid (CS) therapy (Prednisone) compared to CS alone in adults&#xD;
      participants with active Crohn's Disease, on symptoms and inflammation after 6 weeks of&#xD;
      treatment. Participants will be randomized to three treatment arms: standard CS, standard CS&#xD;
      with EEN, short course CS with EEN. Participants will be assessed through questionnaires for&#xD;
      gut symptoms, quality of life, mood changes and dietary patterns and potential mechanisms&#xD;
      will be investigated by collecting stool samples for characterization of gut bacterial&#xD;
      profiles, collection of blood to determine inflammatory markers and evaluation of gut&#xD;
      motility before and after treatment. The investigators hypothesize that six weeks of EEN with&#xD;
      CS will be more effective than CS alone in inducing clinical remission in patients with&#xD;
      active CD, as well as leading to beneficial changes in the composition and/or metabolic&#xD;
      activity of the intestinal microbiota, gastrointestinal transit and inflammatory burden.&#xD;
      Furthermore, six weeks of EEN in addition to a short course of CS will have similar efficacy&#xD;
      than EEN with standard course of CS and reduced number of adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's disease (CD) is an inflammatory bowel disease (IBD) characterized by diarrhea,&#xD;
      abdominal pain and bleeding. There are several treatment options but the most-widely used for&#xD;
      acute therapy are corticosteroids (CS), however, CS are often associated with severe side&#xD;
      effects. The administration of a formula for exclusive feeding (EEN) is well-established as&#xD;
      an alternative to CS in children with Crohn's disease (CD). EEN has been proposed to reduce&#xD;
      inflammation in the gut. However, this intervention is not routinely used in adults, in part&#xD;
      because of uncertainty regarding the magnitude of the benefit of EEN reported in previous&#xD;
      studies. Although few studies have examined the effects of EEN in adult patients with active&#xD;
      CD, the potentially synergistic effects of adding EEN to the conventional CS was not&#xD;
      explored. Furthermore, it is also possible that the addition of EEN allows to decrease the&#xD;
      duration of CS therapy; however, this was not investigated before.&#xD;
&#xD;
      The investigators propose that an oral formula may help decrease gut inflammation and improve&#xD;
      nutritional status through modulation of gut bacteria. The investigators will therefore&#xD;
      evaluate the effect of exclusive formula feeding therapy in addition to different regimes of&#xD;
      CS therapy compared to CS alone in adult patients with active CD, on symptoms and&#xD;
      inflammation after 6 weeks of treatment. Participants will be randomized to three treatment&#xD;
      arms: standard CS, standard CS with EEN, short course CS with EEN. The investigators will&#xD;
      collect information through questionnaires that assess gut symptoms, quality of life, mood&#xD;
      changes and dietary patterns. To investigate potential mechanisms, the investigators will&#xD;
      collect stool samples to characterize gut bacterial profiles, blood to determine inflammatory&#xD;
      markers and evaluate gut movements (motility) before, and after the treatment. The&#xD;
      investigators hope that the results will lead to better understanding of the beneficial&#xD;
      effect of exclusive formula feeding in addition to CS as a more efficacious alternative than&#xD;
      CS alone, and to understand the mechanisms of this therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">October 25, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Randomized control trial with three arms of treatment: EEN plus standard or short course of CS versus CS alone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Treatment options are randomized and masked for participants and study staff until Visit 2, where participants and investigators are made aware of treatment arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index - CDAI&lt;150) in adult patients with active CD (CDAI&gt;220 and either CRP&gt;5 or fecal calprotectin &gt;250mg/l)</measure>
    <time_frame>2 years</time_frame>
    <description>Assess the efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index (CDAI)&lt;150) compared to treatment with CS alone in adult patients with active CD (CDAI&gt;220 and either CRP&gt;5 or fecal calprotectin &gt;250mg/l)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement (drop in Crohns Disease Activity Index - CDAI&gt;70)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ)) Total score ranges from 10 to 70 (higher values indicate better outcome). Subscales are divided into systemic (score range 2 to 14), social (score range 2 to 14), bowel (score range 3 to 21) and emotional (score range 3 to 21)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission (normalization of either serum CRP (CRP&lt;5) and/or fecal calprotectin (less than 250mg/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit (SHAPE) among those with altered transit at baseline. Participants will take one capsule containing 24 markers and have an X-Ray done on day 5. If &gt;20% markers (6 markers or more) are retained it is considered delayed transit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores (decrease &gt;2 points in Hospital Anxiety and Depression Scale. Total score ranges from 0 to 42, lower values indicating better outcome. Subscale HAD-A (anxiety) and HAD-D (depression) range from 0 to 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in increasing body weight and improving nutritional status</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in increasing body weight and improving nutritional status (increased levels of micronutrients: vitamin A, vitamin B12, 25-hydroxy vitamin D, chromium, copper and zinc)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing number of adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing number of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing changes in microbiota composition</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing changes in microbiota composition (change in alpha diversity by 16S sequencing Illumina)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing indirect markers of mucosal integrity</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing indirect markers of mucosal integrity (IFABP2)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Standard course CS with Regular Food</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg a day of oral Prednisone for 2 weeks with subsequent taper of daily dose by 5 mg per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard course CS with EEN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg a day of oral Prednisone for 2 weeks and taper of daily dose by 5 mg per week and Exclusive Enteral Nutrition for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short course CS with EEN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg a day of oral Prednisone for 3 days and taper of daily dose by 5 mg every 3 days and Exclusive Enteral Nutrition for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>All 3 arms will receive Prednisone - 2 will be standard course treatment, 1 will be short course and rapidly-tapered</description>
    <arm_group_label>Short course CS with EEN</arm_group_label>
    <arm_group_label>Standard course CS with EEN</arm_group_label>
    <arm_group_label>Standard course CS with Regular Food</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Exclusive Enteral Nutrition</intervention_name>
    <description>2 arms will receive EEN, in concurrence with either regular-course or short course and rapidly-tapered CS.</description>
    <arm_group_label>Short course CS with EEN</arm_group_label>
    <arm_group_label>Standard course CS with EEN</arm_group_label>
    <other_name>Modulen (Nestlé)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed CD for at least 6 months&#xD;
&#xD;
          -  Clinically active disease (CDAI &gt;220 or Harvey-Bradshaw Index (HBI) &gt;6) or active by&#xD;
             endoscopy.&#xD;
&#xD;
          -  Biochemical evidence of disease activity (CRP &gt;5 and/or fecal calprotectin &gt;250)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently using EEN&#xD;
&#xD;
          -  Condition that would preclude the use of EEN, such as Intestinal obstruction,&#xD;
             perforation, toxic megacolon, massive gastrointestinal bleeding, abdominal abscess, or&#xD;
             stricturing disease&#xD;
&#xD;
          -  Previous intestinal resection with a remnant bowel of less than 180 cm&#xD;
&#xD;
          -  Treatment with Prednisone in the last 30 days&#xD;
&#xD;
          -  New start or change in dose of azathioprine, 6-mercaptopurine, cyclosporine, other&#xD;
             immunosuppressant or biologics in the last 90 days. Doses of these medications must&#xD;
             also remain unchanged for the duration of the study&#xD;
&#xD;
          -  New start or change in dose of 5-aminosalicylic acid (ASA) in the last 30 days. 5ASA&#xD;
             dose must remain unchanged for the duration of the study&#xD;
&#xD;
          -  Use of Antibiotics or Probiotics in the last 30 days&#xD;
&#xD;
          -  Pregnant or Lactating&#xD;
&#xD;
          -  Any serious illness which could interfere with study procedures or results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria I Pinto-Sanchez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton, ON</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Maria Ines Pinto Sanchez</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Medicine</investigator_title>
  </responsible_party>
  <keyword>Corticosteroids</keyword>
  <keyword>Exclusive Enteral Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03833596/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03833596
org study id: EEN in Crohn
nct id: NCT03833596
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates the effect of Exclusive Enteral Nutrition (EEN) in addition to different
      regimes of corticosteroid (CS) therapy (Prednisone) compared to CS alone in adults
      participants with active Crohn's Disease, on symptoms and inflammation after 6 weeks of
      treatment. Participants will be randomized to three treatment arms: standard CS, standard CS
      with EEN, short course CS with EEN. Participants will be assessed through questionnaires for
      gut symptoms, quality of life, mood changes and dietary patterns and potential mechanisms
      will be investigated by collecting stool samples for characterization of gut bacterial
      profiles, collection of blood to determine inflammatory markers and evaluation of gut
      motility before and after treatment. The investigators hypothesize that six weeks of EEN with
      CS will be more effective than CS alone in inducing clinical remission in patients with
      active CD, as well as leading to beneficial changes in the composition and/or metabolic
      activity of the intestinal microbiota, gastrointestinal transit and inflammatory burden.
      Furthermore, six weeks of EEN in addition to a short course of CS will have similar efficacy
      than EEN with standard course of CS and reduced number of adverse events.
Crohn's disease (CD) is an inflammatory bowel disease (IBD) characterized by diarrhea,
      abdominal pain and bleeding. There are several treatment options but the most-widely used for
      acute therapy are corticosteroids (CS), however, CS are often associated with severe side
      effects. The administration of a formula for exclusive feeding (EEN) is well-established as
      an alternative to CS in children with Crohn's disease (CD). EEN has been proposed to reduce
      inflammation in the gut. However, this intervention is not routinely used in adults, in part
      because of uncertainty regarding the magnitude of the benefit of EEN reported in previous
      studies. Although few studies have examined the effects of EEN in adult patients with active
      CD, the potentially synergistic effects of adding EEN to the conventional CS was not
      explored. Furthermore, it is also possible that the addition of EEN allows to decrease the
      duration of CS therapy; however, this was not investigated before.

      The investigators propose that an oral formula may help decrease gut inflammation and improve
      nutritional status through modulation of gut bacteria. The investigators will therefore
      evaluate the effect of exclusive formula feeding therapy in addition to different regimes of
      CS therapy compared to CS alone in adult patients with active CD, on symptoms and
      inflammation after 6 weeks of treatment. Participants will be randomized to three treatment
      arms: standard CS, standard CS with EEN, short course CS with EEN. The investigators will
      collect information through questionnaires that assess gut symptoms, quality of life, mood
      changes and dietary patterns. To investigate potential mechanisms, the investigators will
      collect stool samples to characterize gut bacterial profiles, blood to determine inflammatory
      markers and evaluate gut movements (motility) before, and after the treatment. The
      investigators hope that the results will lead to better understanding of the beneficial
      effect of exclusive formula feeding in addition to CS as a more efficacious alternative than
      CS alone, and to understand the mechanisms of this therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trial with three arms of treatment: EEN plus standard or short course of CS versus CS alone.
primary purpose: Treatment
masking: None (Open Label)
masking description: Treatment options are randomized and masked for participants and study staff until Visit 2, where participants and investigators are made aware of treatment arm.
measure: Efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index - CDAI<150) in adult patients with active CD (CDAI>220 and either CRP>5 or fecal calprotectin >250mg/l)
time frame: 2 years
description: Assess the efficacy of 6 weeks of EEN and CS in inducing remission (Crohn's Disease Activity Index (CDAI)<150) compared to treatment with CS alone in adult patients with active CD (CDAI>220 and either CRP>5 or fecal calprotectin >250mg/l)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing clinical disease improvement (drop in Crohns Disease Activity Index - CDAI>70)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in improving quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ)) Total score ranges from 10 to 70 (higher values indicate better outcome). Subscales are divided into systemic (score range 2 to 14), social (score range 2 to 14), bowel (score range 3 to 21) and emotional (score range 3 to 21)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing biochemical remission (normalization of either serum CRP (CRP<5) and/or fecal calprotectin (less than 250mg/l)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in normalizing colonic transit (SHAPE) among those with altered transit at baseline. Participants will take one capsule containing 24 markers and have an X-Ray done on day 5. If >20% markers (6 markers or more) are retained it is considered delayed transit.
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing anxiety and/or depression scores (decrease >2 points in Hospital Anxiety and Depression Scale. Total score ranges from 0 to 42, lower values indicating better outcome. Subscale HAD-A (anxiety) and HAD-D (depression) range from 0 to 21.
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in increasing body weight and improving nutritional status
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in increasing body weight and improving nutritional status (increased levels of micronutrients: vitamin A, vitamin B12, 25-hydroxy vitamin D, chromium, copper and zinc)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing number of adverse events
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing number of adverse events
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing changes in microbiota composition
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in inducing changes in microbiota composition (change in alpha diversity by 16S sequencing Illumina)
measure: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing indirect markers of mucosal integrity
time frame: 2 years
description: Determine the beneficial effect of 6 weeks of EEN and CS as compared to CS alone in decreasing indirect markers of mucosal integrity (IFABP2)
arm group label: Standard course CS with Regular Food
arm group type: Active Comparator
description: 40 mg a day of oral Prednisone for 2 weeks with subsequent taper of daily dose by 5 mg per week.
arm group label: Standard course CS with EEN
arm group type: Experimental
description: 40 mg a day of oral Prednisone for 2 weeks and taper of daily dose by 5 mg per week and Exclusive Enteral Nutrition for 6 weeks.
arm group label: Short course CS with EEN
arm group type: Experimental
description: 40 mg a day of oral Prednisone for 3 days and taper of daily dose by 5 mg every 3 days and Exclusive Enteral Nutrition for 6 weeks.
intervention type: Drug
intervention name: Prednisone
description: All 3 arms will receive Prednisone - 2 will be standard course treatment, 1 will be short course and rapidly-tapered
arm group label: Short course CS with EEN
arm group label: Standard course CS with EEN
arm group label: Standard course CS with Regular Food
intervention type: Dietary Supplement
intervention name: Exclusive Enteral Nutrition
description: 2 arms will receive EEN, in concurrence with either regular-course or short course and rapidly-tapered CS.
arm group label: Short course CS with EEN
arm group label: Standard course CS with EEN
other name: Modulen (Nestlé)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Maria I Pinto-Sanchez, MD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Maria Ines Pinto Sanchez
investigator title: Assistant Professor, Department of Medicine
mesh term: Crohn Disease
mesh term: Prednisone
provided document: 