<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/NCT01705522</url>
  </required_header>
  <id_info>
    <org_study_id>COL-GASTRO-3</org_study_id>
    <nct_id>NCT01705522</nct_id>
  </id_info>
  <brief_title>Multimodal Approach in IBD Patients</brief_title>
  <acronym>MAID</acronym>
  <official_title>Multimodal Approach in IBD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Hospital Colentina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Hospital Colentina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to assess the role of several biomarkers in the prediction of&#xD;
      relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive&#xD;
      score will be derived in order to assess the relapse risk at 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis&#xD;
      in order to assess relapse risk factors.&#xD;
&#xD;
      Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's&#xD;
      disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC&#xD;
      patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.&#xD;
&#xD;
      Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal&#xD;
      calprotectin).&#xD;
&#xD;
      Data about current and past medication for IBD will also be gathered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical relapse</measure>
    <time_frame>1 year</time_frame>
    <description>clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of NAFLD</measure>
    <time_frame>1 year</time_frame>
    <description>to assess the prevalence of nonalcoholic liver disease in IBD patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prevalence of vitamin D deficiency</measure>
    <time_frame>1 year</time_frame>
    <description>to assess vitamin D deficiency and osteopenia among IBD patients</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Ulcerative Colitis</condition>
  <condition>Crohn's Disease</condition>
  <condition>Nonalcoholic Fatty Liver Disease (NAFLD)</condition>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>IBD patients</arm_group_label>
    <description>patients with ulcerative colitis or crohn's disease, in remission</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and fecal samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        all patients with IBD over 18 years of age, currently in clinical remission&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ulcerative colitis or Crohn's disease&#xD;
&#xD;
          -  age over 18&#xD;
&#xD;
          -  clinical remission&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  refusal to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodor Voiosu, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Hospital Colentina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theodor A Voiosu, MD</last_name>
    <phone>0040726732764</phone>
    <email>theodor.voiosu@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Colentina Clinical Hospital</name>
      <address>
        <city>Bucharest</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreea Bengus, MD</last_name>
      <phone>0040744497626</phone>
      <email>andreeabengus@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Theodor A Voiosu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <citation>Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. doi: 10.1023/a:1018895500721.</citation>
    <PMID>9246063</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Hospital Colentina</investigator_affiliation>
    <investigator_full_name>dr. Theodor Alexandru Voiosu</investigator_full_name>
    <investigator_title>Gastroenterology resident, Teaching Assistant</investigator_title>
  </responsible_party>
  <keyword>IBD</keyword>
  <keyword>ulcerative colitis</keyword>
  <keyword>Crohn's disease</keyword>
  <keyword>NAFLD</keyword>
  <keyword>biomarkers</keyword>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Vitamin D Deficiency</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/NCT01705522
org study id: COL-GASTRO-3
nct id: NCT01705522
lead sponsor: 
has dmc: No
The investigators intend to assess the role of several biomarkers in the prediction of
      relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive
      score will be derived in order to assess the relapse risk at 1 year.
Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis
      in order to assess relapse risk factors.

      Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's
      disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC
      patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.

      Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal
      calprotectin).

      Data about current and past medication for IBD will also be gathered.
observational model: Cohort
time perspective: Prospective
measure: Clinical relapse
time frame: 1 year
description: clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
measure: Prevalence of NAFLD
time frame: 1 year
description: to assess the prevalence of nonalcoholic liver disease in IBD patients
measure: prevalence of vitamin D deficiency
time frame: 1 year
description: to assess vitamin D deficiency and osteopenia among IBD patients
arm group label: IBD patients
description: patients with ulcerative colitis or crohn's disease, in remission
serum and fecal samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Theodor Voiosu, Md
role: Principal Investigator
affiliation: Clinical Hospital Colentina
last name: Theodor A Voiosu, MD
phone: 0040726732764
email: theodor.voiosu@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Romania
citation: Dionne S, Hiscott J, D'Agata I, Duhaime A, Seidman EG. Quantitative PCR analysis of TNF-alpha and IL-1 beta mRNA levels in pediatric IBD mucosal biopsies. Dig Dis Sci. 1997 Jul;42(7):1557-66. doi: 10.1023/a:1018895500721.
PMID: 9246063
responsible party type: Principal Investigator
investigator affiliation: Clinical Hospital Colentina
investigator full name: dr. Theodor Alexandru Voiosu
investigator title: Gastroenterology resident, Teaching Assistant
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Liver Diseases
mesh term: Colitis, Ulcerative
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Vitamin D Deficiency