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/NCT05976165</url>
    </required_header>
    <id_info>
      <org_study_id>22-007268</org_study_id>
      <nct_id>NCT05976165</nct_id>
    </id_info>
    <brief_title>A Study of Breath Testing for Small Intestinal Bacterial Overgrowth</brief_title>
    <official_title>Breath Testing for Small Intestinal Bacterial Overgrowth in Patients Treated With Proton Pump Inhibitors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</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>
        Researchers hope to determine how often small intestinal bacterial overgrowth occurs after&#xD;
        taking proton pump inhibitors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of SIBO after treatment with PPI</measure>
      <time_frame>After PPI therapy, approximately 8 weeks</time_frame>
      <description>Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Symptoms of SIBO after treatment with PPI</measure>
      <time_frame>After PPI therapy, approximately 8 weeks</time_frame>
      <description>Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of SIBO before treatment with a PPI</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptoms of SIBO before treatment with a PPI</measure>
      <time_frame>Baseline</time_frame>
      <description>Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Gastroesophageal Reflux</condition>
    <condition>Regurgitation</condition>
    <condition>Heartburn</condition>
    <arm_group>
      <arm_group_label>Breath Test Evaluation for SIBO</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breath Testing</intervention_name>
      <description>Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours</description>
      <arm_group_label>Breath Test Evaluation for SIBO</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Predominant symptoms of gastroesophageal reflux disease including heartburn,&#xD;
               regurgitation&#xD;
  &#xD;
            -  Subjects must be able to give appropriate informed consent&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Use of PPIs or H2R-anatagonstists in the prior 3 months&#xD;
  &#xD;
            -  Major concomitant illness (renal, hepatic, rheumatologic or cardiovascular disease, or&#xD;
               malignancy)&#xD;
  &#xD;
            -  Antibiotic therapy within one month&#xD;
  &#xD;
            -  Prior gastrointestinal surgery including esophageal, gastric, and small or large bowel&#xD;
               surgery&#xD;
  &#xD;
            -  Previously diagnosed irritable bowel syndrome or inflammatory bowel disease&#xD;
  &#xD;
            -  Individuals who are pregnant or breast feeding&#xD;
  &#xD;
            -  Patients with plans to become pregnant&#xD;
  &#xD;
            -  Inability to take PPIs, including allergy/sensitivity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andree Koop, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mayo Clinic Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Andree H. Koop</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Proton pump inhibitor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroesophageal Reflux</mesh_term>
      <mesh_term>Heartburn</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/NCT05976165
  org study id: 22-007268
  nct id: NCT05976165
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Researchers hope to determine how often small intestinal bacterial overgrowth occurs after
        taking proton pump inhibitors.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of SIBO after treatment with PPI
  time frame: After PPI therapy, approximately 8 weeks
  description: Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) after clinical treatment of proton pump inhibitors (PPI ).
  measure: Symptoms of SIBO after treatment with PPI
  time frame: After PPI therapy, approximately 8 weeks
  description: Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention.
  measure: Incidence of SIBO before treatment with a PPI
  time frame: Baseline
  description: Number of subjects to have a positive breath testing for small intestinal bacterial overgrowth (SIBO) before clinical treatment of proton pump inhibitors (PPI ).
  measure: Symptoms of SIBO before treatment with a PPI
  time frame: Baseline
  description: Measured using the self-reported Mayo Bloating Questionnaire to assess symptoms of bloating and abdominal distension. Comprised of 45 questions addressing symptoms of bloating/distention.
  arm group label: Breath Test Evaluation for SIBO
  arm group type: Experimental
  description: Subjects with symptoms of gastroesophageal reflux disease (GERD) treated with a short course of proton pump inhibitors (PPI) clinically will undergo breath testing evaluating for small intestinal bacterial overgrowth (SIBO).
  intervention type: Other
  intervention name: Breath Testing
  description: Subjects drink a small carbohydrate solution, and then provide a breath sample every 15 minutes for one hour, and then every 30 minutes for the next two hours
  arm group label: Breath Test Evaluation for SIBO
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Andree Koop, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Andree H. Koop
  investigator title: Principal Investigator
  mesh term: Gastroesophageal Reflux
  mesh term: Heartburn
  sharing ipd: No