<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/NCT02242175</url>
  </required_header>
  <id_info>
    <org_study_id>1-2014-0046</org_study_id>
    <nct_id>NCT02242175</nct_id>
  </id_info>
  <brief_title>Efficacy of Hydrogen Breath Test in the Patients With Irritable Bowel Syndrome</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It&#xD;
      is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not&#xD;
      proven. So, the treatment's target is the relief of the symptoms.&#xD;
&#xD;
      Small intestinal bacterial overgrowth considered as the cause of the irritable bowel&#xD;
      syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal&#xD;
      discomfort could be relieved after taking antibiotics. There are several diagnostic methods&#xD;
      for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for&#xD;
      diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off&#xD;
      value for the hydrogen breath test. So, we want to compare the hydrogen breath test between&#xD;
      the irritable bowel syndrome patients and normal people. And then, we want to analyze the&#xD;
      efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people</measure>
    <time_frame>Within the 24 hours after 8-12 hours fasting</time_frame>
    <description>The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people</measure>
    <time_frame>Within the 24 hours after 8-12 hours fasting</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">147</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>normal group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>irritable bowel syndrome group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glucose breath test (hydrogen breath test)</intervention_name>
    <description>Glucose breath test (hydrogen breath test) is the current gold standard for diagnosis of irritable bowel syndrome. Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen or methane gas as a by-product. The breath sample will be analyzed for hydrogen or methane content to determine if you are able to properly break down the lactose, fructose or sucrose, or if you have bacterial overgrowth.</description>
    <arm_group_label>irritable bowel syndrome group</arm_group_label>
    <arm_group_label>normal group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. over 19 years old, male and female&#xD;
&#xD;
          2. normal people (control group, who has no abdominal symptoms - diarrhea, constipation&#xD;
             etc.)&#xD;
&#xD;
          3. irritable bowel syndrome patients (irritable bowel syndrome means that within the last&#xD;
             3 months abdominal discomfort more than three days for a month and satisfies over the&#xD;
             below two items) 1) symptom relived after defecation 2) bowel habit change, the times&#xD;
             of defecation changed 3) the change of the morphology of the stool&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who do not agree for participation&#xD;
&#xD;
          2. patients who have history for treatment of irritable bowel syndrome&#xD;
&#xD;
          3. patients who is uncontrolled diabetes mellitus&#xD;
&#xD;
          4. patients who have small bowel or large bowel diseases&#xD;
&#xD;
          5. patients who had surgery for abdomen&#xD;
&#xD;
          6. patients who are taking antibiotics, anti-depressants within 1 week&#xD;
&#xD;
          7. patients who are taking proton pump inhibitors or opioids for analgesics&#xD;
&#xD;
          8. patients who have history of bowel adhesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yong Chan Lee, MD</last_name>
    <phone>82-2-2228-1960</phone>
    <email>leeyc@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sevrance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong Chan Lee, MD</last_name>
      <phone>82-2-2228-1960</phone>
      <email>leeyc@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT02242175
org study id: 1-2014-0046
nct id: NCT02242175
lead sponsor: 
has dmc: No
Irritable bowel syndrome is characterized by abdominal discomfort and bowel habit change. It
      is increasing worldwide. But the pathophysiology of the irritable bowel syndrome is not
      proven. So, the treatment's target is the relief of the symptoms.

      Small intestinal bacterial overgrowth considered as the cause of the irritable bowel
      syndrome. Because, it is related to the postprandial abdominal discomfort and the abdominal
      discomfort could be relieved after taking antibiotics. There are several diagnostic methods
      for small intestinal bacterial overgrowth. hydrogen breath test is non-invasive method for
      diagnosis of the small intestinal bacterial overgrowth. But, there is no standardized cut-off
      value for the hydrogen breath test. So, we want to compare the hydrogen breath test between
      the irritable bowel syndrome patients and normal people. And then, we want to analyze the
      efficacy of hydrogen breath test for the diagnosis of irritable bowel syndrome.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
time frame: Within the 24 hours after 8-12 hours fasting
description: The difference of H2 elevation level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
measure: The difference of methane level through the hydrogen breath test between the irritable bowel syndrome patients and the normal people
time frame: Within the 24 hours after 8-12 hours fasting
arm group label: normal group
arm group type: Other
arm group label: irritable bowel syndrome group
arm group type: Other
intervention type: Device
intervention name: Glucose breath test (hydrogen breath test)
description: Glucose breath test (hydrogen breath test) is the current gold standard for diagnosis of irritable bowel syndrome. Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen or methane gas as a by-product. The breath sample will be analyzed for hydrogen or methane content to determine if you are able to properly break down the lactose, fructose or sucrose, or if you have bacterial overgrowth.
arm group label: irritable bowel syndrome group
arm group label: normal group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yong Chan Lee, MD
phone: 82-2-2228-1960
email: leeyc@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome