<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/NCT03760133</url>
  </required_header>
  <id_info>
    <org_study_id>2018-07-024</org_study_id>
    <nct_id>NCT03760133</nct_id>
  </id_info>
  <brief_title>The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics</brief_title>
  <official_title>The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kosin University Gospel Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cell Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kosin University Gospel Hospital</source>
  <oversight_info>
    <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>
      The purpose of this study is to investigate the relationship between the change of intestinal&#xD;
      bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort&#xD;
      after colonoscopy. And the investigators will also analyze the effects of probiotics on the&#xD;
      degree of change, recovery, and symptom development in intestinal flora.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators divided two groups. (total number = 100 subjects)&#xD;
&#xD;
        1. with probiotics group - 50 subjects&#xD;
&#xD;
             -  Participants included in this group will be taken probiotics for 1 month after&#xD;
                bowel preparation for colonoscopy.&#xD;
&#xD;
        2. without probiotics group - 50 subjects&#xD;
&#xD;
             -  Participants included in this group will not be taken probiotics for 1 month after&#xD;
                bowel preparation for colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of probiotics on the change of gut microbiota after bowel preparation.</measure>
    <time_frame>eight months</time_frame>
    <description>Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The occurrence of symptoms</measure>
    <time_frame>eight months</time_frame>
    <description>Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation between symptoms and gut microbiota..</measure>
    <time_frame>eight months</time_frame>
    <description>Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Gut Microbiota</condition>
  <condition>Bowel Preparation</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>with Probiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without Probiotics</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duolac</intervention_name>
    <description>Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.</description>
    <arm_group_label>with Probiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults between the age of 30 and 70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with cancer or IBD (inflammatory bowel disease)&#xD;
&#xD;
          -  subjects with history of abdominal surgery&#xD;
&#xD;
          -  subjects who take medication related to gastrointestinal motility within 3 months&#xD;
&#xD;
          -  subjects who take antibiotics within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49267</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kosin University Gospel Hospital</investigator_affiliation>
    <investigator_full_name>Jae Hyun Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Gut microbiota</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Bowel preparation</keyword>
  <keyword>Probiotics</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators have no plan to share IPD to other researchers.</ipd_description>
  </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/NCT03760133
org study id: 2018-07-024
nct id: NCT03760133
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to investigate the relationship between the change of intestinal
      bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort
      after colonoscopy. And the investigators will also analyze the effects of probiotics on the
      degree of change, recovery, and symptom development in intestinal flora.
The investigators divided two groups. (total number = 100 subjects)

        1. with probiotics group - 50 subjects

             -  Participants included in this group will be taken probiotics for 1 month after
                bowel preparation for colonoscopy.

        2. without probiotics group - 50 subjects

             -  Participants included in this group will not be taken probiotics for 1 month after
                bowel preparation for colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The effect of probiotics on the change of gut microbiota after bowel preparation.
time frame: eight months
description: Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.
measure: The occurrence of symptoms
time frame: eight months
description: Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.
measure: The correlation between symptoms and gut microbiota..
time frame: eight months
description: Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.
arm group label: with Probiotics
arm group type: Active Comparator
description: Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
arm group label: without Probiotics
arm group type: No Intervention
description: Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.
intervention type: Drug
intervention name: Duolac
description: Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
arm group label: with Probiotics
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kosin University Gospel Hospital
investigator full name: Jae Hyun Kim
investigator title: Assistant Professor
sharing ipd: No
ipd description: The investigators have no plan to share IPD to other researchers.