<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/NCT01674088</url>
  </required_header>
  <id_info>
    <org_study_id>SBT-01</org_study_id>
    <nct_id>NCT01674088</nct_id>
  </id_info>
  <brief_title>Sucrose Breath Test to Determine Intestinal Permeability in IBS</brief_title>
  <official_title>The Use of a Novel 13C Sucrose Breath Test (13C SBT) to Determine Intestinal Permeability in Irritable Bowel Syndrome (IBS) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metabolic Solutions Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Metabolic Solutions Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US&#xD;
      population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of&#xD;
      the disease still remains unclear. It has been hypothesized that patients with IBS have&#xD;
      alterations in the intestinal lining leading to release of toxic substances into the blood,&#xD;
      commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive&#xD;
      and invasive. The investigators will test a new breath test to measure leaky gut in both IBS&#xD;
      patients and subjects without IBS symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of&#xD;
      sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects&#xD;
      meet eligibility criteria, a single breath test will be conducted on all subjects. The breath&#xD;
      test involves collecting breath by exhaling through a straw into a special test tube. A&#xD;
      breath sample is collected before administration of sucrose. After the baseline breath&#xD;
      sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three&#xD;
      additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the&#xD;
      protocol is finished. We will be analyzing breath carbon dioxide for different levels of&#xD;
      heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer.&#xD;
      Our study plan is to compare the amount of carbon-13 in breath between IBS patients and&#xD;
      subjects without the condition. Up to 20 subjects per group will be studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose</measure>
    <time_frame>90 minutes</time_frame>
    <description>AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Irritable Bowel Syndrome</arm_group_label>
    <description>Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinics of Shands Hospital, Gainesville, FL, residents within Gainesville, FL&#xD;
        and students of the University of Florida.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or females with clinical diagnosis of Irritable Bowel Syndrome by Rome III&#xD;
             criteria (IBS Group) or healthy control.&#xD;
&#xD;
          -  Must be 18 years old or greater.&#xD;
&#xD;
          -  Women of child-bearing potential must have a negative pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females who are lactating or pregnant.&#xD;
&#xD;
          -  Subjects with allergy to sucrose.&#xD;
&#xD;
          -  Subjects with other causes of abdominal pain or altered bowel habits such as IBD,&#xD;
             celiac disease, pancreatitis or gastrointestinal bleeding.&#xD;
&#xD;
          -  Subjects with a history of diabetes mellitus.&#xD;
&#xD;
          -  Subjects with a recent febrile illness (5 days prior to study).&#xD;
&#xD;
          -  Subjects that received an investigational drug or device within 30 days prior to study&#xD;
             entry.&#xD;
&#xD;
          -  Subjects that do not have the mental capacity to understand the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David A Wagner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Metabolic Solutions Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>February 6, 2014</last_update_submitted>
  <last_update_submitted_qc>February 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irritable Bowel Syndrome</keyword>
  <keyword>breath testing</keyword>
  <keyword>carbon-13</keyword>
  <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/NCT01674088
org study id: SBT-01
nct id: NCT01674088
lead sponsor: 
collaborator: 
has dmc: Yes
Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US
      population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of
      the disease still remains unclear. It has been hypothesized that patients with IBS have
      alterations in the intestinal lining leading to release of toxic substances into the blood,
      commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive
      and invasive. The investigators will test a new breath test to measure leaky gut in both IBS
      patients and subjects without IBS symptoms.
The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of
      sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects
      meet eligibility criteria, a single breath test will be conducted on all subjects. The breath
      test involves collecting breath by exhaling through a straw into a special test tube. A
      breath sample is collected before administration of sucrose. After the baseline breath
      sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three
      additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the
      protocol is finished. We will be analyzing breath carbon dioxide for different levels of
      heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer.
      Our study plan is to compare the amount of carbon-13 in breath between IBS patients and
      subjects without the condition. Up to 20 subjects per group will be studied.
observational model: Case-Control
time perspective: Prospective
measure: Area under the breath 13CO2 concentration versus time curve (AUC) of sucrose
time frame: 90 minutes
description: AUC curves will be generated after measurement of breath carbon-13 labeled carbon dioxide over 90 minutes of collection.
arm group label: Irritable Bowel Syndrome
description: Subjects meeting Rome III criteria will be included as the group Irritable Bowel Syndrome
arm group label: Healthy Controls
description: Subjects not meeting Rome III criteria and meeting clinical definitions of general good health will be considered as Healthy Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David A Wagner, PhD
role: Principal Investigator
affiliation: Metabolic Solutions Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome