<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/NCT01698970</url>
  </required_header>
  <id_info>
    <org_study_id>NU098</org_study_id>
    <nct_id>NCT01698970</nct_id>
  </id_info>
  <brief_title>Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease</brief_title>
  <official_title>Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danone Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups&#xD;
      of adult patients operated on for Crohn's disease, to determine if oral ingestion of&#xD;
      probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic&#xD;
      lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or&#xD;
      control product (N=56) during one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <completion_date type="Actual">March 2010</completion_date>
  <primary_completion_date type="Actual">March 2007</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>1 = Tested product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2 = Control product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)</intervention_name>
    <description>1- 6 test products/day</description>
    <arm_group_label>1 = Tested product</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2- excipients (150 mg) in capsule (control)</intervention_name>
    <description>2- 6 control poducts/day</description>
    <arm_group_label>2 = Control product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male/female at least 18 years old&#xD;
&#xD;
          -  Diagnosis of Crohn's disease defined by the criteria usually adopted (Gower-Rousseau,&#xD;
             1994)&#xD;
&#xD;
          -  Crohn's disease mainly limited to the terminal ileum and/or the ascending and&#xD;
             transverse colon&#xD;
&#xD;
          -  Diagnosis of Crohn's disease in agreement with surgical specimen analysis&#xD;
&#xD;
          -  Patient having given its written consent to take part in the study&#xD;
&#xD;
          -  Complete resection of all main macroscopic ileo-colonic lesions, as shown by&#xD;
             inspection at surgery&#xD;
&#xD;
          -  To have an ileo-colic resection (right, transverse, left) with an anastomosis that can&#xD;
             be inspected by endoscopy&#xD;
&#xD;
          -  Ability to start oral nutrition and therefore the consumption of the study product&#xD;
             within 21 days of surgery&#xD;
&#xD;
          -  Patient receiving no antibiotics at the beginning of the product consumption&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  One or more intestinal resection during the 5 last years before the last surgery&#xD;
&#xD;
          -  Presence of any severe additional disease&#xD;
&#xD;
          -  For female patient : pregnancy or breast feeding&#xD;
&#xD;
          -  For pre-menopausal female patient : no effective contraceptive methods used (combined&#xD;
             oestrogen-progestogen pill or Intrauterine Device)&#xD;
&#xD;
          -  Patient currently in an exclusion period following participation in another clinical&#xD;
             trial&#xD;
&#xD;
          -  Patient in a situation which in the investigator's opinion could interfere with&#xD;
             optimal participation in the present study or could constitute a special risk for the&#xD;
             patient&#xD;
&#xD;
          -  Significant presence of Crohn's disease in other intestinal tracts&#xD;
&#xD;
          -  Small bowel cumulative resection exceeding 1 meter&#xD;
&#xD;
          -  Patient with ileostomy&#xD;
&#xD;
          -  Subtotal colectomy with ileo-rectal anastomosis&#xD;
&#xD;
          -  Severe post-operative septic complications (fistula, peritonitis), leading to&#xD;
             administration of more than 15 days of post-operative antibiotherapy)&#xD;
&#xD;
          -  Intake of unauthorised treatments (mesalazine, olsalazine or sulfasalazine,&#xD;
             5-Aminosalicylates (5-ASA) or 4-Aminosalicylates (4-ASA)) ; corticoïds and&#xD;
             immunosuppressors) after surgery except corticoids which will have to be stopped&#xD;
             within 6 weeks after surgery according to standardised stepwise dose reductions&#xD;
&#xD;
          -  Patient under artificial nutrition&#xD;
&#xD;
          -  Subject with a loss of personal liberty, by administrative or judicial decision, or&#xD;
             major with a legal guardian&#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>Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Probiotic</keyword>
  <keyword>capsules</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>recurrent endoscopic ileo-colonic lesions</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>
  <!-- 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/NCT01698970
org study id: NU098
nct id: NCT01698970
lead sponsor: 
has dmc: No
A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups
      of adult patients operated on for Crohn's disease, to determine if oral ingestion of
      probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic
      lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or
      control product (N=56) during one year.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
arm group label: 1 = Tested product
arm group type: Experimental
arm group label: 2 = Control product
arm group type: Placebo Comparator
intervention type: Other
intervention name: 1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)
description: 1- 6 test products/day
arm group label: 1 = Tested product
intervention type: Other
intervention name: 2- excipients (150 mg) in capsule (control)
description: 2- 6 control poducts/day
arm group label: 2 = Control product
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