<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/NCT02255370</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0207</org_study_id>
    <secondary_id>2014-000261-51</secondary_id>
    <nct_id>NCT02255370</nct_id>
  </id_info>
  <brief_title>Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease</brief_title>
  <acronym>POPCUR</acronym>
  <official_title>Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3i nature</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naturopôle Nutrition santé</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of&#xD;
      inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible&#xD;
      for the anti-inflammatory effect of curcumin&#xD;
&#xD;
      Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with&#xD;
      thiopurines in the prevention of Crohn's disease post-operative recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      122 subjects, operated on for Crohn disease, will be included in the study. After&#xD;
      ileo-colonic resection, subjects will be randomized into two arms; they will be given either&#xD;
      placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner.&#xD;
      Rutggerts endoscopic score at 6 months will be the main judgment criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rutgeerts endoscopic score</measure>
    <time_frame>at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CDAI score</measure>
    <time_frame>at 6 months and at 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgeerts endoscopic score according to smoking status (yes/no)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgeerts endoscopic score according to anoperineal lesions (yes/no)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rutgeerts endoscopic score according to length of intestinal resection &gt;0.5m</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>CURCUMIN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLACEBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Curcumin</intervention_name>
    <description>subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria</description>
    <arm_group_label>CURCUMIN</arm_group_label>
    <arm_group_label>PLACEBO</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Crohn's disease confirmed by radiographic, endoscopic or histologic criteria&#xD;
&#xD;
          -  Age &gt; 18 yr&#xD;
&#xD;
          -  Affiliated to french health insurance&#xD;
&#xD;
          -  Operated on less than 15 days ago for ileal, colonic or ileo-colonic Crohn's disease&#xD;
             with all macroscopic lesions being removed, with an anastomosis which can be reached&#xD;
             by ileocolonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ulcerative colitis&#xD;
&#xD;
          -  Pregnant or nursing woman&#xD;
&#xD;
          -  Refusal of contraceptive measure for childbearing potential, woman or fertile man&#xD;
&#xD;
          -  Indication of anti-TNFα treatment&#xD;
&#xD;
          -  Concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate,&#xD;
             cyclosporine, tacrolimus, anti-TNFα, ustekinumab, vedolizumab&#xD;
&#xD;
          -  Concomitant treatment with corticosteroids, except in case of tapering a treatment&#xD;
             initiated before surgery&#xD;
&#xD;
          -  Renal insufficiency ( serum creatinine 2N)&#xD;
&#xD;
          -  Chronic hepatic disease except for primary sclerosing cholangitis&#xD;
&#xD;
          -  ALAT , ASAT, alkaline phosphatases, or bilirubin &gt; 3N&#xD;
&#xD;
          -  Current infection to HIV, HBV (except if HBV Ac positives), HCV&#xD;
&#xD;
          -  Contraindication to thiopurines&#xD;
&#xD;
          -  Unwillingness of the patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Curcumin. Crohn's disease. Post-operative recurrence. Thiopurines . Rutgeerts endoscopic score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</mesh_term>
  </intervention_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/NCT02255370
org study id: CHU-0207
secondary id: 2014-000261-51
nct id: NCT02255370
lead sponsor: 
collaborator: 
collaborator: 
Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of
      inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible
      for the anti-inflammatory effect of curcumin

      Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with
      thiopurines in the prevention of Crohn's disease post-operative recurrence.
122 subjects, operated on for Crohn disease, will be included in the study. After
      ileo-colonic resection, subjects will be randomized into two arms; they will be given either
      placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner.
      Rutggerts endoscopic score at 6 months will be the main judgment criteria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rutgeerts endoscopic score
time frame: at 6 months
measure: CDAI score
time frame: at 6 months and at 1 year
measure: Rutgeerts endoscopic score according to smoking status (yes/no)
time frame: at 6 months
measure: Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)
time frame: at 6 months
measure: Rutgeerts endoscopic score according to anoperineal lesions (yes/no)
time frame: at 6 months
measure: Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)
time frame: at 6 months
measure: Rutgeerts endoscopic score according to length of intestinal resection >0.5m
time frame: at 6 months
arm group label: CURCUMIN
arm group type: Experimental
description: subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
arm group label: PLACEBO
arm group type: Placebo Comparator
description: subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
intervention type: Drug
intervention name: Curcumin
description: subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
arm group label: CURCUMIN
arm group label: PLACEBO
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Recurrence
mesh term: Curcumin