<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/NCT03261856</url>
  </required_header>
  <id_info>
    <org_study_id>1114725</org_study_id>
    <nct_id>NCT03261856</nct_id>
  </id_info>
  <brief_title>Clinical Utility of Breath Tests in GI</brief_title>
  <official_title>Clinical Utility of Carbohydrate Breath Tests in Unexplained GI Symptoms</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative;&#xD;
      these patients are labeled as IBS. In these patients, whether testing for carbohydrate&#xD;
      malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear.&#xD;
      Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the&#xD;
      usefulness of breath tests, and predictive value of pre-test symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abdominal bloating, gas, belching, distension, and diarrhea are common gastrointestinal&#xD;
      symptoms that are reported by at least 1/3rd of patients presenting to gastroenterology&#xD;
      clinics. When routine endoscopic and radiological tests are negative1, most of these patients&#xD;
      are labeled as irritable bowel syndrome (IBS) in gastroenterology practice2. Unfortunately&#xD;
      these symptoms persist and these patients remain dissatisfied with their health care and&#xD;
      continue to doctor shops or seek remedies from alternative care. Several studies have shown&#xD;
      that these symptoms have a significant and negative impact on their quality of life. One&#xD;
      possible explanation for their symptom is carbohydrate food intolerance. The Western diet has&#xD;
      changed significantly over the last 3 decades. Today, large amounts of fructose are being&#xD;
      consumed. This sugar is used as a sweetener in sodas, fruit juices, multiples beverages and&#xD;
      candies. Although is naturally present in apples, peaches, pears and oranges, the exponential&#xD;
      products and consumption of the synthetic high fructose corn syrup has alarmingly increased&#xD;
      fructose consumption. When small amounts are ingested, fructose is completely absorbed from&#xD;
      the gut mainly through Glut 5transporter from the intestinal brush border or through&#xD;
      facilitated transport along glucose through the Glut 2 transporter5. If a person has either&#xD;
      limited absorptive capacity or overwhelms normal absorption capacity by excess ingestion,&#xD;
      then malabsorption of fructose ensues. This unabsorbed fructose can serve, as an osmotic&#xD;
      load, that draws fluid into the intestinal lumen, causing abdominal bloating, gas, pain and&#xD;
      diarrhea 6-7. Likewise lactose is a disaccharide that is present in dairy products and is&#xD;
      widely consumed. After ingestion lactose is hydrolyzed in the small intestine by the brush&#xD;
      border enzyme lactase into glucose and galactose that are in torn absorbed8. If lactose is&#xD;
      malabsorbed by Glut 2, then it will serve as an osmotic load, and get rapidly propelled in to&#xD;
      the colon where it is fermented by the colonic bacterial flora, into short chain fatty acid,&#xD;
      hydrogen,methane and other gases, this lactose malabsorption produces gas, bloating,&#xD;
      flatulence and diarrhea9. About 75% of the world´s population gradually lose their ability to&#xD;
      produce the lactase enzyme after age 30 years10-11.&#xD;
&#xD;
      Malabsorption or intolerance of carbohydrates such as fructose and lactose are common and&#xD;
      frequently encountered both in the primary care and specialist gastroenterology clinics, but&#xD;
      are poorly recognized or treated. Over the last decade, breath testing has emerged as a&#xD;
      simple, non invasive method of identifying malabsorption and/ or intolerance to common food&#xD;
      ingredients such as fructose12, and lactose13, as well as to identify small intestinal&#xD;
      bacterial overgrowth (SIBO)14. However, they are only performed in selected academic centers,&#xD;
      and their clinical utility and diagnostic yield largely remains unknown.&#xD;
&#xD;
      Also may the clinical utility of performing a single breath test versus a cumulative battery&#xD;
      of breath tests, such as glucose, lactose or fructose breath test, in a patient with&#xD;
      unexplained GI symptoms is also not known.&#xD;
&#xD;
      The aims of this study are to investigate a consecutive series of patients with unexplained&#xD;
      chronic GI symptoms and examine; 1) the prevalence of SIBO answered by the glucose breath&#xD;
      test, fructose and lactose intolerance answered by the fructose y lactose breath test, ; 2)&#xD;
      the predictive value of pre-test symptoms in the diagnosis of SIBO or carbohydrate&#xD;
      intolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2011</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Small Intestinal Bacterial Overgrowth</measure>
    <time_frame>3 hour test</time_frame>
    <description>bacterial overgrowth which results in the inability to absorb nutrients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive Breath test</measure>
    <time_frame>3 hour test</time_frame>
    <description>significant increase in the level of Hydrogen greater than or equal to 20ppm or methane greater than or equal to 15ppm or both above greater than or equal to 15ppm baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Malabsorption</measure>
    <time_frame>3 hour test</time_frame>
    <description>significant rise in hydrogen and/or methane levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intolerance</measure>
    <time_frame>3 hour test</time_frame>
    <description>both the presence of malabsorption and the onset of new symptom or an increase (greater than or equal to 1) in the severity of baseline symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Normal test</measure>
    <time_frame>3 hour test</time_frame>
    <description>absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hypersensitivity</measure>
    <time_frame>3 hour test</time_frame>
    <description>significant increase (greater than or equal to 1) in the severity of two or more baseline symptoms together with no significant rise in hydrogen or methane levels</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1080</enrollment>
  <condition>Small Intestinal Bacterial Overgrowth</condition>
  <condition>Lactose Intolerance</condition>
  <condition>Fructose Intolerance</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>small intetsinal bacterial overgrowth</arm_group_label>
    <description>Glucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fructose breath Test</arm_group_label>
    <description>Fructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactose Breath test</arm_group_label>
    <description>Lactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had breath tests as part of routine standard of care to diagnose the&#xD;
        unexplained GI symptoms that were abnormal results.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 18&#xD;
&#xD;
          -  Unexplained GI symptoms (gas, bloating, diarrhea, fullness, belching, and abdominal&#xD;
             pain)&#xD;
&#xD;
          -  Patients who have had normal blood tests and colonoscopy, normal CT or ultrasound scan&#xD;
             of the abdomen&#xD;
&#xD;
          -  Patients who have completed at least one breath test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous GI surgeries (except cholecystectomy, hysterectomy, Nissen&#xD;
             funduplication and appendectomy)&#xD;
&#xD;
          -  Significant comorbid medical problems (congestive heart failure, chronic renal&#xD;
             failure, respiratory failure)&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  History of recent antibiotic use (4 weeks)&#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>Satish SC Rao, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breath test</keyword>
  <keyword>SIBO</keyword>
  <keyword>GI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactose Intolerance</mesh_term>
    <mesh_term>Fructose Intolerance</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT03261856
org study id: 1114725
nct id: NCT03261856
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bloating, gas, pain and diarrhea are common complaints. Routine investigations are negative;
      these patients are labeled as IBS. In these patients, whether testing for carbohydrate
      malabsorption or small intestinal bacterial overgrowth (SIBO) is useful is unclear.
      Investigators aim to assess the prevalence of SIBO, fructose and lactose intolerance, the
      usefulness of breath tests, and predictive value of pre-test symptoms.
Abdominal bloating, gas, belching, distension, and diarrhea are common gastrointestinal
      symptoms that are reported by at least 1/3rd of patients presenting to gastroenterology
      clinics. When routine endoscopic and radiological tests are negative1, most of these patients
      are labeled as irritable bowel syndrome (IBS) in gastroenterology practice2. Unfortunately
      these symptoms persist and these patients remain dissatisfied with their health care and
      continue to doctor shops or seek remedies from alternative care. Several studies have shown
      that these symptoms have a significant and negative impact on their quality of life. One
      possible explanation for their symptom is carbohydrate food intolerance. The Western diet has
      changed significantly over the last 3 decades. Today, large amounts of fructose are being
      consumed. This sugar is used as a sweetener in sodas, fruit juices, multiples beverages and
      candies. Although is naturally present in apples, peaches, pears and oranges, the exponential
      products and consumption of the synthetic high fructose corn syrup has alarmingly increased
      fructose consumption. When small amounts are ingested, fructose is completely absorbed from
      the gut mainly through Glut 5transporter from the intestinal brush border or through
      facilitated transport along glucose through the Glut 2 transporter5. If a person has either
      limited absorptive capacity or overwhelms normal absorption capacity by excess ingestion,
      then malabsorption of fructose ensues. This unabsorbed fructose can serve, as an osmotic
      load, that draws fluid into the intestinal lumen, causing abdominal bloating, gas, pain and
      diarrhea 6-7. Likewise lactose is a disaccharide that is present in dairy products and is
      widely consumed. After ingestion lactose is hydrolyzed in the small intestine by the brush
      border enzyme lactase into glucose and galactose that are in torn absorbed8. If lactose is
      malabsorbed by Glut 2, then it will serve as an osmotic load, and get rapidly propelled in to
      the colon where it is fermented by the colonic bacterial flora, into short chain fatty acid,
      hydrogen,methane and other gases, this lactose malabsorption produces gas, bloating,
      flatulence and diarrhea9. About 75% of the world´s population gradually lose their ability to
      produce the lactase enzyme after age 30 years10-11.

      Malabsorption or intolerance of carbohydrates such as fructose and lactose are common and
      frequently encountered both in the primary care and specialist gastroenterology clinics, but
      are poorly recognized or treated. Over the last decade, breath testing has emerged as a
      simple, non invasive method of identifying malabsorption and/ or intolerance to common food
      ingredients such as fructose12, and lactose13, as well as to identify small intestinal
      bacterial overgrowth (SIBO)14. However, they are only performed in selected academic centers,
      and their clinical utility and diagnostic yield largely remains unknown.

      Also may the clinical utility of performing a single breath test versus a cumulative battery
      of breath tests, such as glucose, lactose or fructose breath test, in a patient with
      unexplained GI symptoms is also not known.

      The aims of this study are to investigate a consecutive series of patients with unexplained
      chronic GI symptoms and examine; 1) the prevalence of SIBO answered by the glucose breath
      test, fructose and lactose intolerance answered by the fructose y lactose breath test, ; 2)
      the predictive value of pre-test symptoms in the diagnosis of SIBO or carbohydrate
      intolerance.
observational model: Case-Only
time perspective: Retrospective
measure: Small Intestinal Bacterial Overgrowth
time frame: 3 hour test
description: bacterial overgrowth which results in the inability to absorb nutrients
measure: Positive Breath test
time frame: 3 hour test
description: significant increase in the level of Hydrogen greater than or equal to 20ppm or methane greater than or equal to 15ppm or both above greater than or equal to 15ppm baseline.
measure: Malabsorption
time frame: 3 hour test
description: significant rise in hydrogen and/or methane levels
measure: Intolerance
time frame: 3 hour test
description: both the presence of malabsorption and the onset of new symptom or an increase (greater than or equal to 1) in the severity of baseline symptoms
measure: Normal test
time frame: 3 hour test
description: absence of GI symptoms or change in symptoms during the test together with no significant increase in the levels of hydrogen and methane.
measure: hypersensitivity
time frame: 3 hour test
description: significant increase (greater than or equal to 1) in the severity of two or more baseline symptoms together with no significant rise in hydrogen or methane levels
arm group label: small intetsinal bacterial overgrowth
description: Glucose breath test, 75 g glucose in 250 ml water. Breath samples collected at baseline and every 15 min for 2 hours
arm group label: Fructose breath Test
description: Fructose breath test, 25 g fructose in 250 ml water. Breath samples collected at baseline and every 30 min for 3 hours
arm group label: Lactose Breath test
description: Lactose breath test, 25 g lactose in 250 ml water. Breath samples collected at baseline and every 30 min for 5 hours
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Satish SC Rao, MD, PhD
role: Principal Investigator
affiliation: Augusta University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lactose Intolerance
mesh term: Fructose Intolerance
mesh term: Glucose Intolerance