<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/NCT03815136</url>
  </required_header>
  <id_info>
    <org_study_id>CG-HuY-1901</org_study_id>
    <nct_id>NCT03815136</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time</brief_title>
  <acronym>CGCE</acronym>
  <official_title>The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Zhejiang Chinese Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Zhejiang Chinese Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effect of chewing gum, during the first one&#xD;
      hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of&#xD;
      cases with complete small bowel examination and gastroscopy intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will include patients who need to a capsule endoscopy (CE) in this unit. The&#xD;
      investigators will include 200 participants who had a CE at our centre based on the gastric&#xD;
      transit times. These will be randomly divided into two groups. The participants (chew chewing&#xD;
      gum) and the controls (do not chew chewing gum).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>gastric transit time</measure>
    <time_frame>1 hour</time_frame>
    <description>the time interval between the first gastric image and the first duodenal image</description>
  </primary_outcome>
  <primary_outcome>
    <measure>small bowel transit time</measure>
    <time_frame>8 hour</time_frame>
    <description>The time interval between the first duodenal images and the first caecal image</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completion rate</measure>
    <time_frame>9 hours</time_frame>
    <description>the capsule reaching the caecum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield</measure>
    <time_frame>9 hours</time_frame>
    <description>the total number of positive (diagnostic and suspicious) findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention rate</measure>
    <time_frame>1 hours</time_frame>
    <description>Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Gastric Transit Time</condition>
  <condition>Small-bowel Transit Time</condition>
  <arm_group>
    <arm_group_label>Chewing Gum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will not chew chewing gum while undergoing capsule endoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chewing Gum</intervention_name>
    <description>Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.</description>
    <arm_group_label>Chewing Gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The control group will not chew chewing gum while undergoing capsule endoscopy</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥18 years and &lt;80 years old presenting for capsule endoscopy. Obtained&#xD;
             of written informed consent before the procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop&#xD;
             these at least 7 days prior to the procedure.&#xD;
&#xD;
          -  Patients, who have proven or suspected obstruction of the bowel.&#xD;
&#xD;
          -  Patients, who have had prior small bowel and/or gastric surgery.&#xD;
&#xD;
          -  Patients, who have a dysphagia prohibiting.&#xD;
&#xD;
          -  Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Lv, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Zhejiang Chinese Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejiang Chinese Medical University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>May 14, 2020</last_update_submitted>
  <last_update_submitted_qc>May 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual participant data sharing will be consider after study</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03815136/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03815136
org study id: CG-HuY-1901
nct id: NCT03815136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the effect of chewing gum, during the first one
      hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of
      cases with complete small bowel examination and gastroscopy intervention.
The participants will include patients who need to a capsule endoscopy (CE) in this unit. The
      investigators will include 200 participants who had a CE at our centre based on the gastric
      transit times. These will be randomly divided into two groups. The participants (chew chewing
      gum) and the controls (do not chew chewing gum).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
masking description: The patients were instructed not to tell the endoscopist or the investigators about whether or not they used chewing gum before, during, or after the SBCE procedure.
measure: gastric transit time
time frame: 1 hour
description: the time interval between the first gastric image and the first duodenal image
measure: small bowel transit time
time frame: 8 hour
description: The time interval between the first duodenal images and the first caecal image
measure: Completion rate
time frame: 9 hours
description: the capsule reaching the caecum
measure: Diagnostic yield
time frame: 9 hours
description: the total number of positive (diagnostic and suspicious) findings
measure: Intervention rate
time frame: 1 hours
description: Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour
arm group label: Chewing Gum
arm group type: Active Comparator
description: The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination.
arm group label: Control
arm group type: Placebo Comparator
description: The control group will not chew chewing gum while undergoing capsule endoscopy.
intervention type: Other
intervention name: Chewing Gum
description: Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.
arm group label: Chewing Gum
intervention type: Other
intervention name: Control
description: The control group will not chew chewing gum while undergoing capsule endoscopy
arm group label: Control
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bin Lv, M.D.
role: Principal Investigator
affiliation: First Affiliated Hospital of Zhejiang Chinese Medical University
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: Individual participant data sharing will be consider after study
provided document: 