<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/NCT02203955</url>
  </required_header>
  <id_info>
    <org_study_id>14-001220</org_study_id>
    <nct_id>NCT02203955</nct_id>
  </id_info>
  <brief_title>Study of Sc-FOS for Pouchitis Prevention</brief_title>
  <official_title>Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to compare prebiotic therapy with placebo for the prevention of&#xD;
      pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal&#xD;
      anastomosis. This study will also characterize the effects of prebiotics on the fecal&#xD;
      microbiota and fecal microbial metabolites and correlate these effects with the primary&#xD;
      outcome of development of pouchitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year</measure>
    <time_frame>baseline, 1 year</time_frame>
    <description>In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (&lt;7 points).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Pouchitis</condition>
  <arm_group>
    <arm_group_label>Short-Chain Fructooligosaccharide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 chews (8.0 g scFOS) orally per day for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maltodextrin</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>4 chews (maltodextrin) daily for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Short-Chain Fructooligosaccharide</intervention_name>
    <description>4 chews (8.0 g scFOS) orally for 12 months</description>
    <arm_group_label>Short-Chain Fructooligosaccharide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>4 chews (maltodextrin) daily for 12 months</description>
    <arm_group_label>Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Age 18-65 years.&#xD;
&#xD;
          2. History of ulcerative colitis&#xD;
&#xD;
          3. Ileostomy closure after IPAA&#xD;
&#xD;
          4. Ability to give appropriate consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Crohn's disease.&#xD;
&#xD;
          2. Perianal disease (including abscess, fissure, or stricture)&#xD;
&#xD;
          3. Pregnancy&#xD;
&#xD;
          4. Lactation&#xD;
&#xD;
          5. Concurrent treatment for IBD or pouchitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Raffals, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Laura E. Raffals, M.D</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pouchitis</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/NCT02203955
org study id: 14-001220
nct id: NCT02203955
lead sponsor: 
has dmc: No
The main objective is to compare prebiotic therapy with placebo for the prevention of
      pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal
      anastomosis. This study will also characterize the effects of prebiotics on the fecal
      microbiota and fecal microbial metabolites and correlate these effects with the primary
      outcome of development of pouchitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
time frame: baseline, 1 year
description: In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (<7 points).
arm group label: Short-Chain Fructooligosaccharide
arm group type: Active Comparator
description: 4 chews (8.0 g scFOS) orally per day for 12 months
arm group label: Maltodextrin
arm group type: Placebo Comparator
description: 4 chews (maltodextrin) daily for 12 months
intervention type: Drug
intervention name: Short-Chain Fructooligosaccharide
description: 4 chews (8.0 g scFOS) orally for 12 months
arm group label: Short-Chain Fructooligosaccharide
intervention type: Drug
intervention name: Maltodextrin
description: 4 chews (maltodextrin) daily for 12 months
arm group label: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Laura Raffals, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Laura E. Raffals, M.D
investigator title: Assistant Professor of Medicine
mesh term: Pouchitis