<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/NCT02997059</url>
  </required_header>
  <id_info>
    <org_study_id>2006_27</org_study_id>
    <secondary_id>2008-000717-30</secondary_id>
    <secondary_id>PHRC2006R/1903</secondary_id>
    <nct_id>NCT02997059</nct_id>
  </id_info>
  <brief_title>Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.</brief_title>
  <acronym>AscaMC</acronym>
  <official_title>Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was prospective study randomized in two controlled parallel groups verum versus placebo.&#xD;
      The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on&#xD;
      the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our&#xD;
      previous research having established i) a link between intestinal inflammation and the&#xD;
      opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii)&#xD;
      the demonstration that this yeast species could be at the origin of ASCA, a prominent&#xD;
      serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of&#xD;
      ASCA and/or reduce the occurrence of recurrences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Limited recourse to intestinal resection due to new management of CD&#xD;
  </why_stopped>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 2</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>Rate of ASCA</measure>
    <time_frame>6 months</time_frame>
    <description>the dosage of ASCA in the serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of yeast digestive colonization</measure>
    <time_frame>during 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantification of yeast digestive colonization</measure>
    <time_frame>during 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic recurrence : Rutgeerts Score&gt;1</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical recurrence : surgery for CD (except for proctological surgery)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI &gt;=220)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events as a measure of safety</measure>
    <time_frame>during 6 months</time_frame>
    <description>Evaluate the clinical and biological safety of the daily dose of fluconazole in this population</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Crohn's Disease Aggravated</condition>
  <arm_group>
    <arm_group_label>Fluconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200mg per day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One capsule per day for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <description>200 mg/ day</description>
    <arm_group_label>Fluconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Crohn disease patients with a small intestine localisation (ileum or ileocecal)&#xD;
&#xD;
          2. Ileal or ileocecal resection in the month before inclusion (resection of all&#xD;
             macroscopic lesions). If resection with temporary stoma, the patient may be included&#xD;
             at the time of surgery to restore the continuity&#xD;
&#xD;
          3. Patient with low risk of recurrence according to the following criteria:&#xD;
&#xD;
             (i) Total length of the resection(s) of the small intestine less than 100 cm (ii)&#xD;
             Segmental colectomy leaving in place at least another colonic segment as the rectum&#xD;
&#xD;
          4. Preoperative rate of ASCA&gt; 70 arbitrary units (+/- 10%)&#xD;
&#xD;
          5. Informed consent signed to be involved in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women or without adequate contraception&#xD;
&#xD;
          2. Total length of the resection(s) of the small intestine more than 1 meter&#xD;
&#xD;
          3. Subtotal colic resection&#xD;
&#xD;
          4. Preoperative rate of ASCA&lt;63 arbitrary units (+/- 10%)&#xD;
&#xD;
          5. Known hypersensitivity to fluconazole or other azoles&#xD;
&#xD;
          6. Known liver disease or transaminase levels &gt;1.5 the normal rate&#xD;
&#xD;
          7. Patient with renal failure&#xD;
&#xD;
          8. Inability to read and sign the informed consent&#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>Pierre Desreumaux, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU, Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn disease</keyword>
  <keyword>Candida</keyword>
  <keyword>ASCA</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>Fluconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02997059
org study id: 2006_27
secondary id: 2008-000717-30
secondary id: PHRC2006R/1903
nct id: NCT02997059
lead sponsor: 
collaborator: 
has dmc: No
This was prospective study randomized in two controlled parallel groups verum versus placebo.
      The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on
      the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our
      previous research having established i) a link between intestinal inflammation and the
      opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii)
      the demonstration that this yeast species could be at the origin of ASCA, a prominent
      serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of
      ASCA and/or reduce the occurrence of recurrences.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rate of ASCA
time frame: 6 months
description: the dosage of ASCA in the serum
measure: Identification of yeast digestive colonization
time frame: during 6 months
measure: Quantification of yeast digestive colonization
time frame: during 6 months
measure: Endoscopic recurrence : Rutgeerts Score>1
time frame: 6 months
measure: Clinical recurrence : surgery for CD (except for proctological surgery)
time frame: 6 months
measure: Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)
time frame: 6 months
measure: Number of patients with adverse events as a measure of safety
time frame: during 6 months
description: Evaluate the clinical and biological safety of the daily dose of fluconazole in this population
arm group label: Fluconazole
arm group type: Experimental
description: 200mg per day for 6 months
arm group label: Placebo
arm group type: Placebo Comparator
description: One capsule per day for 6 months
intervention type: Drug
intervention name: Fluconazole
description: 200 mg/ day
arm group label: Fluconazole
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Desreumaux, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Fluconazole
sharing ipd: No