<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/NCT04499742</url>
  </required_header>
  <id_info>
    <org_study_id>1328690</org_study_id>
    <nct_id>NCT04499742</nct_id>
  </id_info>
  <brief_title>Comparative Assessment of Radioisotope Glucose and Breath Test</brief_title>
  <official_title>Does Rise in Breath Hydrogen During Endoscopically Assisted Glucose Breath Test (EAGBT) Correlate With Radio-Isotope Location in Small Bowel: Improving Detection of Distal SIBO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study about improving our diagnostic method for small intestinal bacterial&#xD;
      overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose&#xD;
      breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study,&#xD;
      investigators wish to utilize Nuclear Medicine techniques to locate where the glucose&#xD;
      solution that is administered during EAGBT is being consumed by bacteria is in the small&#xD;
      bowel when it detects SIBO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention,&#xD;
      and diarrhea due to colonization and an excessive amount of bacteria in the small bowel.&#xD;
      Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or&#xD;
      ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more&#xD;
      commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral&#xD;
      glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment&#xD;
      glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed&#xD;
      into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath&#xD;
      H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion,&#xD;
      the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum.&#xD;
      Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses&#xD;
      distal SIBO.&#xD;
&#xD;
      Investigators have recently shown that glucose administration into the distal duodenum&#xD;
      through upper endoscopy has a higher positive yield for SIBO in patients with negative oral&#xD;
      GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose&#xD;
      fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the&#xD;
      colon, i.e. false-positive test. Study objective here is to administer a radio-labeled&#xD;
      glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then&#xD;
      determine if the rise in breath hydrogen and/or methane correlates with the location of the&#xD;
      isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath&#xD;
      testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy.&#xD;
      Clinical response to treatment will be assessed on follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 14, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 14, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between GBT result and isotope detection in small bowel</measure>
    <time_frame>February 6, 2019 (anticipated) - December 14, 2021 (anticipated)</time_frame>
    <description>Overall correlation (positive and negative) between the location of glucose isotope in small bowel (imaging) and changes in in hydrogen and methane values obtained during the breath test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of EAGBT compared to oral GBT</measure>
    <time_frame>February 6, 2019 (anticipated) - December 14, 2021 (anticipated)</time_frame>
    <description>We will compare the yield (positive, negative and overall) of endoscopic assisted GBT versus orally administered GBT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of EAGBT compared to duodenal aspirate and culture</measure>
    <time_frame>February 6, 2019 (anticipated) - December 14, 2021 (anticipated)</time_frame>
    <description>We will compare the positive and negative yield of EAGBT with the positive (&gt;1000 CFU/ml) or negative yield of aerobic and anaerobic cultures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom patterns and demographics</measure>
    <time_frame>February 6, 2019 (anticipated) - December 14, 2021 (anticipated)</time_frame>
    <description>Compare the gas and bloating symptom patterns, clinical characteristics predisposing factors including underlying dysmotility and other demographic features between patients with positive and negative EAGBT and cultures.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Small Intestinal Bacterial Overgrowth</condition>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.</intervention_name>
    <description>Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut.</description>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Breath samples will be analyzed using gas chromatography for hydrogen and methane values.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients exhibiting SIBO symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with recent gas, bloating, distension, and suspected SIBO&#xD;
&#xD;
          -  Negative oral GBT&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Previous abdominal surgery except cholecystectomy, appendectomy&#xD;
&#xD;
          -  Diet prep non-adherence&#xD;
&#xD;
          -  Smoking or exercise causing hyperventilation prior to exam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Satish Rao, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tennekoon Karunaratne, MD, PhD</last_name>
    <phone>7067211968</phone>
    <email>tkarunaratne@augusta.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Audrey Eubanks, BS</last_name>
    <phone>7067211968</phone>
    <email>aueubanks@augusta.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Augusta University Digestive Health Research</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tennekoon Karunaratne, MD, PhD</last_name>
      <phone>706-721-1968</phone>
      <email>tkarunaratne@augusta.edu</email>
    </contact>
    <contact_backup>
      <last_name>Audrey Eubanks, BS</last_name>
      <phone>7067211968</phone>
      <email>aueubanks@augusta.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Satish Rao, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>February 19, 2019</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Satish Rao</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m Sulfur Colloid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04499742
org study id: 1328690
nct id: NCT04499742
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a research study about improving our diagnostic method for small intestinal bacterial
      overgrowth (SIBO). Patients undergoing Standard of Care (SOC) Endoscopically assisted glucose
      breath test (EAGBT) will undergo upper endoscopy and glucose breath tests. In this study,
      investigators wish to utilize Nuclear Medicine techniques to locate where the glucose
      solution that is administered during EAGBT is being consumed by bacteria is in the small
      bowel when it detects SIBO.
Small intestinal bacterial overgrowth (SIBO) is characterized by bloating, gas, distention,
      and diarrhea due to colonization and an excessive amount of bacteria in the small bowel.
      Distal SIBO is the presence of excessive amounts of bacteria in the distal jejunum and/or
      ileum. Diagnosis of SIBO requires either duodenal aspirate with culture analysis or more
      commonly with breath hydrogen/methane testing. Hydrogen breath testing often uses either oral
      glucose or lactulose solutions. If bacteria are present in the small bowel they will ferment
      glucose or lactulose, producing hydrogen or methane as a byproduct. These gases are absorbed
      into the bowel, and then eliminated via pulmonary expiration. By detecting a rise in breath
      H2 and CH4 values compared to baseline, SIBO can be diagnosed. However, after oral ingestion,
      the majority of the glucose substrate is absorbed in the duodenum and proximal jejunum.
      Therefore, Glucose breath test (GBT) is good for the detection of proximal SIBO, but misses
      distal SIBO.

      Investigators have recently shown that glucose administration into the distal duodenum
      through upper endoscopy has a higher positive yield for SIBO in patients with negative oral
      GBT. However, it is unclear if the rise in breath H2 or CH4 is because of glucose
      fermentation by bacteria in the distal small bowel or from fermentation by bacteria in the
      colon, i.e. false-positive test. Study objective here is to administer a radio-labeled
      glucose solution into the duodenum via an endoscopically placed nasoduodenal tube, and then
      determine if the rise in breath hydrogen and/or methane correlates with the location of the
      isotopic glucose solution in the bowel by simultaneous nuclear imaging. Results of breath
      testing will also be compared with duodenal aspirate/cultures taken at the time of endoscopy.
      Clinical response to treatment will be assessed on follow up.
observational model: Case-Control
time perspective: Prospective
measure: Correlation between GBT result and isotope detection in small bowel
time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
description: Overall correlation (positive and negative) between the location of glucose isotope in small bowel (imaging) and changes in in hydrogen and methane values obtained during the breath test.
measure: Diagnostic yield of EAGBT compared to oral GBT
time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
description: We will compare the yield (positive, negative and overall) of endoscopic assisted GBT versus orally administered GBT
measure: Diagnostic yield of EAGBT compared to duodenal aspirate and culture
time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
description: We will compare the positive and negative yield of EAGBT with the positive (>1000 CFU/ml) or negative yield of aerobic and anaerobic cultures.
measure: Symptom patterns and demographics
time frame: February 6, 2019 (anticipated) - December 14, 2021 (anticipated)
description: Compare the gas and bloating symptom patterns, clinical characteristics predisposing factors including underlying dysmotility and other demographic features between patients with positive and negative EAGBT and cultures.
intervention type: Radiation
intervention name: Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.
description: Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut.
Breath samples will be analyzed using gas chromatography for hydrogen and methane values.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Satish Rao, MD, PhD
role: Principal Investigator
affiliation: Augusta University
last name: Tennekoon Karunaratne, MD, PhD
phone: 7067211968
email: tkarunaratne@augusta.edu
last name: Audrey Eubanks, BS
phone: 7067211968
email: aueubanks@augusta.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Satish Rao
investigator title: Professor, MD, PhD
mesh term: Technetium Tc 99m Sulfur Colloid
sharing ipd: No