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/NCT05999500</url>
    </required_header>
    <id_info>
      <org_study_id>TEMPLE</org_study_id>
      <nct_id>NCT05999500</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Temple Stay in Irritable Bowel Syndrome</brief_title>
    <official_title>Temple Stay Improves Intestinal Microbiome Profile in Patients With Irritable Bowel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>DongGuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>DongGuk 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>
        This research is a clinical trial aimed at improving the gut microbiome of patients with&#xD;
        Irritable Bowel Syndrome (IBS) through a temple stay experience.&#xD;
  &#xD;
        Participants in the study are expected to participate in a temple stay experience for a&#xD;
        maximum of 8 days. During the temple stay experience, participants are required to fill out a&#xD;
        daily symptom questionnaire related to irritable bowel syndrome and record their diet and&#xD;
        bowel movements using a dedicated mobile application. Upon completion of the temple stay,&#xD;
        participants will conduct an evaluation of personal satisfaction with the experience.&#xD;
  &#xD;
        Through this, the study aims to collect and analyze data related to the Templestay experience&#xD;
        with the goal of improving the gut microbiome of patients with IBS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Irritable Bowel Syndrome (IBS) is a syndrome characterized by recurrent abdominal pain&#xD;
        accompanied by abdominal discomfort, changes in bowel habits, and abdominal bloating. It is a&#xD;
        common condition, affecting approximately 10% of the population in Korea, and its chronic&#xD;
        gastrointestinal symptoms significantly impact patients' daily life and quality of life.&#xD;
  &#xD;
        Factors such as changes in the intestinal microbiota and the intestinal ecosystem are crucial&#xD;
        in its etiology. Modern individuals, who are often exposed to numerous stressors, frequently&#xD;
        experience persistent intestinal hypersensitivity and inflammation. Foods that are not well&#xD;
        digested and fermented in the intestines, producing a significant amount of gas - such as&#xD;
        those rich in seasonings, dairy products, caffeine, and alcohol - are known to trigger&#xD;
        symptoms. Therefore, it is suggested that a controlled environment like a Temple Stay, which&#xD;
        provides both dietary regulation and stress control, could lead to meaningful symptom&#xD;
        improvement. However, there is currently a lack of objective scientific research on this.&#xD;
  &#xD;
        Our research team hypothesizes that a Temple Stay experience of more than a week could&#xD;
        consistently change the microbiome and stabilize psychosocial factors. This might control&#xD;
        chronic intestinal inflammation and hypersensitivity, leading to subjective symptom&#xD;
        improvement and enhanced treatment satisfaction for patients.&#xD;
  &#xD;
        Through this study, we aim to validate the hypothesis that the dietary changes in a Temple&#xD;
        Stay environment will drastically alter patients' dietary intake, enrich the composition of&#xD;
        the gut microbiome, and consequently reduce the symptoms of IBS, thereby improving the&#xD;
        quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>IBS-SSS</measure>
      <time_frame>before the event, during the event, 4-weeks after the event</time_frame>
      <description>symptom score for irritable bowel syndrome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fecal microbiome</measure>
      <time_frame>before the event, during the event, 4-weeks after the event</time_frame>
      <description>Fecal microbiota composition, microbiome, diversity, Difference in the proportion of the species of primary interest</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <condition>Microbial Colonization</condition>
    <arm_group>
      <arm_group_label>Irritable bowel syndrome patients participating in temple stay</arm_group_label>
      <description>We plan to observe a group of patients aged 20-69 with diarrhea-predominant irritable bowel syndrome who have voluntarily agreed to participate in a temple stay for up to 8 days. Observations will be made before the temple stay, immediately after, and then followed up for 4 weeks after the experience.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Temple stay experience</intervention_name>
      <description>Temple stay experience includes diet and behavior changes, such as vegetarian meals (ex. Balwoo Gongyang), mindful eating, no overeating, meditation, participation in daily monastic tasks.</description>
      <arm_group_label>Irritable bowel syndrome patients participating in temple stay</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Feces&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 20-69 with diarrhea-predominant or constipation-predominant irritable bowel&#xD;
          syndrome.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 20-69 with diarrhea-predominant irritable bowel syndrome&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Monk&#xD;
  &#xD;
            -  history of irritable bowel syndrome (constipation-predominant), history of&#xD;
               inflammatory bowel disease, history of colorectal cancer, history of gastrointestinal&#xD;
               resection,&#xD;
  &#xD;
            -  abnormal blood test (liver function test: AST or ALT more than 1.5 times the normal&#xD;
               limit, total bilirubin increase of more than 1.5mg/dL, CCr &lt; 30 mL/min, platelets less&#xD;
               than 100,000, PT/aPTT increase of more than 20% of the normal upper limit),&#xD;
  &#xD;
            -  uncontrolled hypertension and diabetes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jun Kyu Lee, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>DongGuk University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sang Hoon Kim</last_name>
      <phone>+82-31-961-7128</phone>
      <email>spring0107@naver.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dongguk University Ilsan Hospital</name>
        <address>
          <city>Goyang</city>
          <state>Gyeonggi</state>
          <zip>10326</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sun Young Kim</last_name>
        <phone>+82-31-961-7132</phone>
        <email>ksgesy@naver.com</email>
      </contact>
      <investigator>
        <last_name>Jun Kyu Lee</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 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>DongGuk University</investigator_affiliation>
      <investigator_full_name>Sang Hoon Kim</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Irritable Bowel Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Conditionally considering upon request.</ipd_description>
    </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/NCT05999500
  org study id: TEMPLE
  nct id: NCT05999500
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This research is a clinical trial aimed at improving the gut microbiome of patients with
        Irritable Bowel Syndrome (IBS) through a temple stay experience.
  
        Participants in the study are expected to participate in a temple stay experience for a
        maximum of 8 days. During the temple stay experience, participants are required to fill out a
        daily symptom questionnaire related to irritable bowel syndrome and record their diet and
        bowel movements using a dedicated mobile application. Upon completion of the temple stay,
        participants will conduct an evaluation of personal satisfaction with the experience.
  
        Through this, the study aims to collect and analyze data related to the Templestay experience
        with the goal of improving the gut microbiome of patients with IBS.
  Irritable Bowel Syndrome (IBS) is a syndrome characterized by recurrent abdominal pain
        accompanied by abdominal discomfort, changes in bowel habits, and abdominal bloating. It is a
        common condition, affecting approximately 10% of the population in Korea, and its chronic
        gastrointestinal symptoms significantly impact patients' daily life and quality of life.
  
        Factors such as changes in the intestinal microbiota and the intestinal ecosystem are crucial
        in its etiology. Modern individuals, who are often exposed to numerous stressors, frequently
        experience persistent intestinal hypersensitivity and inflammation. Foods that are not well
        digested and fermented in the intestines, producing a significant amount of gas - such as
        those rich in seasonings, dairy products, caffeine, and alcohol - are known to trigger
        symptoms. Therefore, it is suggested that a controlled environment like a Temple Stay, which
        provides both dietary regulation and stress control, could lead to meaningful symptom
        improvement. However, there is currently a lack of objective scientific research on this.
  
        Our research team hypothesizes that a Temple Stay experience of more than a week could
        consistently change the microbiome and stabilize psychosocial factors. This might control
        chronic intestinal inflammation and hypersensitivity, leading to subjective symptom
        improvement and enhanced treatment satisfaction for patients.
  
        Through this study, we aim to validate the hypothesis that the dietary changes in a Temple
        Stay environment will drastically alter patients' dietary intake, enrich the composition of
        the gut microbiome, and consequently reduce the symptoms of IBS, thereby improving the
        quality of life.
  observational model: Cohort
  time perspective: Prospective
  measure: IBS-SSS
  time frame: before the event, during the event, 4-weeks after the event
  description: symptom score for irritable bowel syndrome
  measure: Fecal microbiome
  time frame: before the event, during the event, 4-weeks after the event
  description: Fecal microbiota composition, microbiome, diversity, Difference in the proportion of the species of primary interest
  arm group label: Irritable bowel syndrome patients participating in temple stay
  description: We plan to observe a group of patients aged 20-69 with diarrhea-predominant irritable bowel syndrome who have voluntarily agreed to participate in a temple stay for up to 8 days. Observations will be made before the temple stay, immediately after, and then followed up for 4 weeks after the experience.
  intervention type: Behavioral
  intervention name: Temple stay experience
  description: Temple stay experience includes diet and behavior changes, such as vegetarian meals (ex. Balwoo Gongyang), mindful eating, no overeating, meditation, participation in daily monastic tasks.
  arm group label: Irritable bowel syndrome patients participating in temple stay
  Feces
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 69 Years
  last name: Jun Kyu Lee, Prof.
  role: Principal Investigator
  affiliation: DongGuk University
  last name: Sang Hoon Kim
  phone: +82-31-961-7128
  email: spring0107@naver.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: DongGuk University
  investigator full name: Sang Hoon Kim
  investigator title: Assistant professor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome
  sharing ipd: Undecided
  ipd description: Conditionally considering upon request.