xml: <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/NCT06005805</url>
    </required_header>
    <id_info>
      <org_study_id>DCT-102</org_study_id>
      <nct_id>NCT06005805</nct_id>
    </id_info>
    <brief_title>A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea</brief_title>
    <official_title>A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea: to Evaluate the Effect of Mastic Gum in Participants With Functional Dyspepsia Symptoms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to evaluate the feasibility of a decentralized clinical trial in&#xD;
        South Korea. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does decentralized elements feasible in Korea?&#xD;
  &#xD;
          -  Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients&#xD;
             with functional dyspepsia?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The trial aims to evaluate decentralized elements in South Korea, including clinical&#xD;
        laboratory testing using local laboratories, medication adherence assessment using wearable&#xD;
        devices, analysis of self-kit specimens, delivery and tracking of investigational medication,&#xD;
        real-time remote interview of subjects and e-consent acquisition.&#xD;
  &#xD;
        Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a&#xD;
        dietary supplement for gastric health, and the study aims to explore the effect on the&#xD;
        gastrointestinal symptoms and composition of the stool microbiome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Specimen delivery time</measure>
      <time_frame>up to 1 months</time_frame>
      <description>Time from collection at the local laboratory to delivery of specimen and reporting of results</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-kit success rate</measure>
      <time_frame>up to 1 months</time_frame>
      <description>Fraction of patients who utilized and delivered a self-test kit on the scheduled date</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse event management time</measure>
      <time_frame>up to 1 months</time_frame>
      <description>In the event of an adverse event requiring medical attention, time from report to response</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score</measure>
      <time_frame>baseline, immediately after the intervention</time_frame>
      <description>A self-evaluation questionnaire for dyspepsia score comprised 11 symptoms. Each symptom is measured on a 5-point scale for both frequency and intensity. The total score range from 22 to 110 and higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut Microbiome Index</measure>
      <time_frame>baseline, immediately after the intervention</time_frame>
      <description>An index that combines microbial diversity, the proportion of pro-inflammatory microbes, the proportion of microbes that produce anti-inflammatory substances, and similarity to hunter-gatherers.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Functional Dyspepsia</condition>
    <arm_group>
      <arm_group_label>Mastic gum with dietary modification</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mastic gum with dietary modification (for 21 days)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dietary modification</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Dietary modification (for 21 days)</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Mastic gum</intervention_name>
      <description>Mastic gum 3g/pack daily for 21 days</description>
      <arm_group_label>Mastic gum with dietary modification</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dietary modification</intervention_name>
      <description>Adhere to the dietary recommendations for Korean dyspepsia patients</description>
      <arm_group_label>Dietary modification</arm_group_label>
      <arm_group_label>Mastic gum with dietary modification</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          1) Inclusion Criteria&#xD;
  &#xD;
            1. Adults aged 19 to 75 years old at the time of consent.&#xD;
  &#xD;
            2. The sum of the intensity and frequency score of the six major symptoms (epigastric&#xD;
               pain, early satiety, postprandial fullness, bloating, belching and nausea) of the&#xD;
               self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) is 12 or more.&#xD;
  &#xD;
          2) Exclusion Criteria&#xD;
  &#xD;
            1. Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia,&#xD;
               bloody stools) that may suggest a malignant disease of the gastrointestinal tract.&#xD;
  &#xD;
            2. Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic&#xD;
               esophagitis.&#xD;
  &#xD;
            3. Have or have had clinically significant hepatic, renal, neurologic, respiratory,&#xD;
               endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.&#xD;
  &#xD;
            4. Pregnant or lactating women&#xD;
  &#xD;
            5. Have or have had a history of clinically significant hypersensitivity to the dietary&#xD;
               supplement to be administered.&#xD;
  &#xD;
            6. Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper&#xD;
               limit of normal range on screening tests&#xD;
  &#xD;
            7. Subjects who are expected to take other medications within the study period that may&#xD;
               affect the evaluation of the effectiveness of the study substance (gastrointestinal&#xD;
               motility promoters, acid secretagogues, proton pump inhibitors, nonsteroidal&#xD;
               anti-inflammatory drugs, anticholinergics, erythromycin, corticosteroids,&#xD;
               antidepressants, etc.&#xD;
  &#xD;
            8. Those deemed by the investigator to be unsuitable for participation in the clinical&#xD;
               trial due to other reasons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kyung-Sang Yu, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiyeon Park, MD</last_name>
      <phone>+82 2 2072 1666</phone>
      <email>creativepennant@snu.ac.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital Clinical Trial Center</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiyeon Park, MD</last_name>
        <phone>+82 2 2072 1666</phone>
        <email>creativepennant@snu.ac.kr</email>
      </contact>
      <investigator>
        <last_name>Kyung-Sang Yu, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Kyung-Sang Yu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyspepsia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005805
  org study id: DCT-102
  nct id: NCT06005805
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to evaluate the feasibility of a decentralized clinical trial in
        South Korea. The main questions it aims to answer are:
  
          -  Does decentralized elements feasible in Korea?
  
          -  Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients
             with functional dyspepsia?
  The trial aims to evaluate decentralized elements in South Korea, including clinical
        laboratory testing using local laboratories, medication adherence assessment using wearable
        devices, analysis of self-kit specimens, delivery and tracking of investigational medication,
        real-time remote interview of subjects and e-consent acquisition.
  
        Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a
        dietary supplement for gastric health, and the study aims to explore the effect on the
        gastrointestinal symptoms and composition of the stool microbiome.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Specimen delivery time
  time frame: up to 1 months
  description: Time from collection at the local laboratory to delivery of specimen and reporting of results
  measure: Self-kit success rate
  time frame: up to 1 months
  description: Fraction of patients who utilized and delivered a self-test kit on the scheduled date
  measure: Adverse event management time
  time frame: up to 1 months
  description: In the event of an adverse event requiring medical attention, time from report to response
  measure: Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score
  time frame: baseline, immediately after the intervention
  description: A self-evaluation questionnaire for dyspepsia score comprised 11 symptoms. Each symptom is measured on a 5-point scale for both frequency and intensity. The total score range from 22 to 110 and higher scores mean a worse outcome.
  measure: Gut Microbiome Index
  time frame: baseline, immediately after the intervention
  description: An index that combines microbial diversity, the proportion of pro-inflammatory microbes, the proportion of microbes that produce anti-inflammatory substances, and similarity to hunter-gatherers.
  arm group label: Mastic gum with dietary modification
  arm group type: Experimental
  description: Mastic gum with dietary modification (for 21 days)
  arm group label: Dietary modification
  arm group type: Placebo Comparator
  description: Dietary modification (for 21 days)
  intervention type: Dietary Supplement
  intervention name: Mastic gum
  description: Mastic gum 3g/pack daily for 21 days
  arm group label: Mastic gum with dietary modification
  intervention type: Behavioral
  intervention name: Dietary modification
  description: Adhere to the dietary recommendations for Korean dyspepsia patients
  arm group label: Dietary modification
  arm group label: Mastic gum with dietary modification
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kyung-Sang Yu, MD, PhD
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Jiyeon Park, MD
  phone: +82 2 2072 1666
  email: creativepennant@snu.ac.kr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Kyung-Sang Yu
  investigator title: Professor
  mesh term: Dyspepsia
  sharing ipd: No