<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/NCT01728870</url>
  </required_header>
  <id_info>
    <org_study_id>0164-12-WOMC</org_study_id>
    <nct_id>NCT01728870</nct_id>
  </id_info>
  <brief_title>Partial Enteral Nutrition With a Unique Diet vs. Exclusive Enteral Nutrition for the Treatment of Pediatric Crohn's Disease</brief_title>
  <official_title>Comparison of Partial Enteral Nutririon (Modulen) With a Unique Diet to Exclusive Enteral Nutrition (Modulen) for the Treatment of Pediatric Crohn's Disease. A Prospective Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Arie Levine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and tolerability of a novel dietary&#xD;
      intervention for early CD based on partial enteral nutrition, and to compare it to the gold&#xD;
      standard but difficult to implement dietary intervention- Exclusive enteral nutrition with&#xD;
      Modulen .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Crohn's disease is clearly on the rise in countries exposed to industrialization&#xD;
      and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease&#xD;
      activity. The strongest argument for an effect of diet is the effect of exclusive enteral&#xD;
      nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet,&#xD;
      irrespective of which diet, will enter complete remission, often with normalization of&#xD;
      inflammatory markers. The effect of formula has been shown to be independent of fat or&#xD;
      protein composition in pediatric studies, but to be dependent on exclusion of normal&#xD;
      diet.Thus, rather than the composition of EEN being associated with remission of disease it&#xD;
      may be the exclusion of certain components of the Western diet may be responsible for&#xD;
      improvement.&#xD;
&#xD;
      Methods:This is a prospective randomized controlled trial, in patients with a recent&#xD;
      diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.&#xD;
&#xD;
      Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle)&#xD;
      and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6&#xD;
      weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization)&#xD;
      will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups.&#xD;
      Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be&#xD;
      allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but&#xD;
      continue restricted diet.&#xD;
&#xD;
      Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.&#xD;
&#xD;
      We hypothesize that by withdrawing the offending dietary agents we can achieve an equal&#xD;
      remission rate with improved tolerability. This study will evaluate response, remission and&#xD;
      tolerability in both groups, as well as the effects of nutrition on bone health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</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>patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component),</measure>
    <time_frame>6 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone health</measure>
    <time_frame>at the 3, and 6 month visits</time_frame>
    <description>change in serum bone biomarkers from baseline and their correlation with DEXA (optional)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP at week 12</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician assessment of compliance</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>Unique Diet+Partial Enteral Nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unique Diet+Partial Enteral Nutrition (PEN): This group will receive as follows:&#xD;
Weeks 1-6: 50% of dietary needs from PEN (Modulen, Nestle) and 50% from a limited whole food diet.&#xD;
Weeks 7-12: 25% of dietary needs from PEN (Modulen, Nestle) and 75% from a limited whole food diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exclusive Enteral Nutrition (Modulen)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exclusive Enteral Nutrition(EEN): This group will receive as follows:&#xD;
Weeks 1-6: EEN(100% of dietary needs from Modulen) Weeks 7-12: 25% of dietary needs from Modulen and 75% from a free diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unique Diet+Partial Enteral Nutrition</intervention_name>
    <description>Modulen - liquid dietary formula</description>
    <arm_group_label>Unique Diet+Partial Enteral Nutrition</arm_group_label>
    <other_name>Modulen, Nestle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exclusive Enteral Nutrition (Modulen)</intervention_name>
    <arm_group_label>Exclusive Enteral Nutrition (Modulen)</arm_group_label>
    <other_name>Modulen, Nestle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children 4-18 years of age.&#xD;
&#xD;
          2. Patients with a diagnosis of CD-duration of disease up to 36 months&#xD;
&#xD;
          3. Have macroscopic small bowel involvement, or isolated large bowel disease confined to&#xD;
             the right or transverse colon&#xD;
&#xD;
          4. Patients with a pediatric activity index -PCDAI ≥ 10&#xD;
&#xD;
          5. Patients will not be excluded if they have received 5ASA or an immunomodulator for &gt;8&#xD;
             weeks and the dose is stable , or if they start a thiopurine concurrently , as&#xD;
             thiopurines are not considered sufficient to induce remission in active disease before&#xD;
             8 weeks as an isolated therapy.&#xD;
&#xD;
          6. Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with no disease activity ( PCDAI &lt;10) or severe disease ( PCDAI ≥ 40).&#xD;
&#xD;
          2. Patients who have received corticosteroids of any kind in the previous 4 weeks.&#xD;
&#xD;
          3. Patients who have started an immunomodulator in the previous 8 weeks&#xD;
&#xD;
          4. Any current biological treatment&#xD;
&#xD;
          5. Isolated Large bowel disease ( L2) involving the recto-sigmoid or descending colon&#xD;
&#xD;
          6. Patients with penetrating disease (abscess or fistula)&#xD;
&#xD;
          7. Active Perianal disease&#xD;
&#xD;
          8. Fixed stricture or small bowel obstruction&#xD;
&#xD;
          9. Normal CRP and ESR&#xD;
&#xD;
         10. Active joint disease.&#xD;
&#xD;
         11. Patients who have undergone an intestinal resection.&#xD;
&#xD;
         12. Sclerosing Cholangitis&#xD;
&#xD;
         13. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arie Levine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatric Gastroenterology and Nutrition unit, Wolfson MC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The E. Wolfson.Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>58100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>July 3, 2018</last_update_submitted>
  <last_update_submitted_qc>July 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Prof. Arie Levine</investigator_full_name>
    <investigator_title>Director, Pediatric Gastroenterology and Nutrition unit.</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>Mild to moderate Crohn's Disease</keyword>
  <keyword>Diet</keyword>
  <keyword>Enteral Nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT01728870
org study id: 0164-12-WOMC
nct id: NCT01728870
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy and tolerability of a novel dietary
      intervention for early CD based on partial enteral nutrition, and to compare it to the gold
      standard but difficult to implement dietary intervention- Exclusive enteral nutrition with
      Modulen .
Background: Crohn's disease is clearly on the rise in countries exposed to industrialization
      and western diet. Several factors may implicate diet in the pathogenesis of CD or in disease
      activity. The strongest argument for an effect of diet is the effect of exclusive enteral
      nutrition (EEN) on disease activity in CD. 40-80% of children , fed an exclusive liquid diet,
      irrespective of which diet, will enter complete remission, often with normalization of
      inflammatory markers. The effect of formula has been shown to be independent of fat or
      protein composition in pediatric studies, but to be dependent on exclusion of normal
      diet.Thus, rather than the composition of EEN being associated with remission of disease it
      may be the exclusion of certain components of the Western diet may be responsible for
      improvement.

      Methods:This is a prospective randomized controlled trial, in patients with a recent
      diagnosis of CD (up to two years),aged 4-18, comparing two arms over 12 weeks of therapy.

      Group 1:will receive 50% of their dietary needs from a polymeric formula ( Modulen, Nestle)
      and a limited whole food diet for 6 weeks/ Group 2: will receive EEN with Modulen for 6
      weeks. At the end of 6 weeks, all patients entering remission (irrespective of randomization)
      will enter the second 6 week phase, continuing 25 % of calories as Modulen in both groups.
      Patients in remission from group 2 will continue to consume 25% of calories as Modulen and be
      allowed free diet , patients in Group 1 will continue 25% of calories from Modulen but
      continue restricted diet.

      Patients will be seen at onset (week 0), weeks 3 and 6, 12 and 24 weeks.

      We hypothesize that by withdrawing the offending dietary agents we can achieve an equal
      remission rate with improved tolerability. This study will evaluate response, remission and
      tolerability in both groups, as well as the effects of nutrition on bone health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: patient's adherence with the diet assessed by cessation of therapy because of patients refusal to continue and by a MARS questionnaire
time frame: 6 weeks
measure: Response, defined as a drop in PCDAI of 12.5 points or remission, on an intention to treat analysis.
time frame: 6 weeks
measure: Remission at week 6 and week 12 (defined as PCDAI≤10, or less than 7.5 without height component),
time frame: 6 weeks and 12 weeks
measure: Bone health
time frame: at the 3, and 6 month visits
description: change in serum bone biomarkers from baseline and their correlation with DEXA (optional)
measure: CRP at week 12
time frame: 12 weeks
measure: Physician assessment of compliance
time frame: 6 weeks
arm group label: Unique Diet+Partial Enteral Nutrition
arm group type: Experimental
description: Unique Diet+Partial Enteral Nutrition (PEN): This group will receive as follows:
Weeks 1-6: 50% of dietary needs from PEN (Modulen, Nestle) and 50% from a limited whole food diet.
Weeks 7-12: 25% of dietary needs from PEN (Modulen, Nestle) and 75% from a limited whole food diet.
arm group label: Exclusive Enteral Nutrition (Modulen)
arm group type: Active Comparator
description: Exclusive Enteral Nutrition(EEN): This group will receive as follows:
Weeks 1-6: EEN(100% of dietary needs from Modulen) Weeks 7-12: 25% of dietary needs from Modulen and 75% from a free diet.
intervention type: Other
intervention name: Unique Diet+Partial Enteral Nutrition
description: Modulen - liquid dietary formula
arm group label: Unique Diet+Partial Enteral Nutrition
other name: Modulen, Nestle
intervention type: Other
intervention name: Exclusive Enteral Nutrition (Modulen)
arm group label: Exclusive Enteral Nutrition (Modulen)
other name: Modulen, Nestle
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Arie Levine, MD
role: Principal Investigator
affiliation: Pediatric Gastroenterology and Nutrition unit, Wolfson MC
facility: 
facility: 
facility: 
country: Canada
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Prof. Arie Levine
investigator title: Director, Pediatric Gastroenterology and Nutrition unit.
mesh term: Crohn Disease