<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/NCT04411017</url>
  </required_header>
  <id_info>
    <org_study_id>EII_Prep</org_study_id>
    <nct_id>NCT04411017</nct_id>
  </id_info>
  <brief_title>Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease</brief_title>
  <acronym>EII_Prep</acronym>
  <official_title>Protocol for Optimizing Colonoscopy Preparation in Patients With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Paz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory&#xD;
      Bowel Disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium&#xD;
      picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing&#xD;
      diagnostic or follow-up routine colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 20, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel cleansing</measure>
    <time_frame>1 year</time_frame>
    <description>Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a &quot;segment score&quot; from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment related adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Number of Participants with symptomatology related to intervention in each arm of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparation Tolerability: total volume of solution finally taken by the patient</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluation of total volume of solution finally taken by the patient</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>1L PEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2L PEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2L sodium picosulfate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopy</intervention_name>
    <description>Colonoscopy</description>
    <arm_group_label>1L PEG</arm_group_label>
    <arm_group_label>2L PEG</arm_group_label>
    <arm_group_label>2L sodium picosulfate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18y and 90y&#xD;
&#xD;
          -  Patients with a diagnosis of IBD undergoing follow-up or screening colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt;18y or &gt;90y&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Patients with a past history of inadequate bowel cleansing in a colonoscopy performed&#xD;
             in the previous 12 months prior to initiation of study&#xD;
&#xD;
          -  Patients with a history of bowel resection&#xD;
&#xD;
          -  Patients undergoing therapeutic colonoscopy&#xD;
&#xD;
          -  Patients unable to understand study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Dolores Martin Arranz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <state>Madrd</state>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 24, 2019</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Paz</investigator_affiliation>
    <investigator_full_name>María Dolores Martín Arranz, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Inflammatory Bowel Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_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/NCT04411017
org study id: EII_Prep
nct id: NCT04411017
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clinical trial evaluating efficacy of bowel cleansing solutions in patients with Inflammatory
      Bowel Disease.
Simple blind, randomized study evaluating efficacy of 1LPEG vs 2L PEG vs 2L sodium
      picosulfate in bowel cleansing of patients diagnosed of Inflammatory Bowel Disease undergoing
      diagnostic or follow-up routine colonoscopy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Bowel cleansing
time frame: 1 year
description: Boston Bowel Preparation Score (BBPS), a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0.
measure: Treatment related adverse events
time frame: 1 year
description: Number of Participants with symptomatology related to intervention in each arm of the study
measure: Preparation Tolerability: total volume of solution finally taken by the patient
time frame: 1 year
description: Evaluation of total volume of solution finally taken by the patient
arm group label: 1L PEG
arm group type: Active Comparator
arm group label: 2L PEG
arm group type: Active Comparator
arm group label: 2L sodium picosulfate
arm group type: Active Comparator
intervention type: Procedure
intervention name: Endoscopy
description: Colonoscopy
arm group label: 1L PEG
arm group label: 2L PEG
arm group label: 2L sodium picosulfate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Dolores Martin Arranz, PhD
role: Principal Investigator
affiliation: Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Paz
investigator full name: María Dolores Martín Arranz, PhD
investigator title: Principal Investigator
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No