<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/NCT02981888</url>
  </required_header>
  <id_info>
    <org_study_id>1606244063</org_study_id>
    <nct_id>NCT02981888</nct_id>
  </id_info>
  <brief_title>Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome</brief_title>
  <acronym>IBS</acronym>
  <official_title>Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome and Control Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out the relationship between the bile acids, fatty acids&#xD;
      (fatty acids are part of the diet) and bacteria that are present in the intestines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is emerging evidence that alterations in bile acids and SCFA associated with IBS could&#xD;
      be associated with changes in the gut microbiota. In addition to modulating levels of&#xD;
      intraluminal organic acids, it has been hypothesized that gut microbiota may alter local&#xD;
      immune responses, modulate visceral pain responses, and impair gut barrier function.&#xD;
&#xD;
      Our overall goal is to investigate the relationship between fecal bile acids, SCFA and the&#xD;
      gut microbiota in IBS. Results of this pilot study could reveal insights into the interplay&#xD;
      of the gut microbiota and small molecule mediators of IBS to suggest targeted clinical&#xD;
      strategies for improved diagnosis and management of this important syndrome.&#xD;
&#xD;
      AIM 1: Test the hypothesis that fecal organic acids (SFCA and bile acids) and fecal&#xD;
      microbiota play an important role in IBS.&#xD;
&#xD;
      AIM 2: Test the hypothesis that there is association between colonic transit and fecal&#xD;
      microbiota in IBS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Total and individual fecal bile acid excretion</measure>
    <time_frame>two days</time_frame>
    <description>Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total fecal excretion of short chain fatty acids</measure>
    <time_frame>two days</time_frame>
    <description>Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal microbial population and community from stool collection</measure>
    <time_frame>two days</time_frame>
    <description>Stool samples will be be collected from participants for nucleic acid extraction, 16S allele PCR and sequencing to measure microbial communities and profiles of specimens</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fecal excretion of individual short chain fatty acids</measure>
    <time_frame>two days</time_frame>
    <description>Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool characteristics</measure>
    <time_frame>14 days</time_frame>
    <description>Stool characteristics will be measured using a 14 day bowel diary</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall and segmental colon transit</measure>
    <time_frame>7 days</time_frame>
    <description>Colonic transit time will be measured in days using radiopaque markers</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>IBS</condition>
  <arm_group>
    <arm_group_label>IBS-C</arm_group_label>
    <description>all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBS-D</arm_group_label>
    <description>all patients with IBS-D will undergo an abdominal x-ray for assessment of colonic transit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>heathy control</arm_group_label>
    <description>all healthy controls will undergo an abdominal x-ray for assessment of colonic transit</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>X-Ray</intervention_name>
    <description>X-ray of the abdomen will be performed to assess colonic transit</description>
    <arm_group_label>IBS-C</arm_group_label>
    <arm_group_label>IBS-D</arm_group_label>
    <arm_group_label>heathy control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target study population will be patients with IBS (both diarrhea- and&#xD;
        constipation-predominant) and healthy controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls&#xD;
             with no prior history of GI disease or symptoms.&#xD;
&#xD;
          -  Participants should be on a stable and consistent diet regimen and should not be&#xD;
             following an extreme diet intervention such as gluten-free or a low FODMAP diet at the&#xD;
             time of study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel&#xD;
             disease, celiac disease, visceral cancer, chronic infectious disease,&#xD;
             immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of&#xD;
             elevated AST/ALT &gt; 2.0x the upper limit of normal&#xD;
&#xD;
          -  Prior radiation therapy of the abdomen or abdominal surgeries with the exception of&#xD;
             appendectomy or cholecystectomy &gt; 6 months prior to study initiation&#xD;
&#xD;
          -  Ingestion of any prescription, over the counter, or herbal medications which can&#xD;
             affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics,&#xD;
             norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2&#xD;
             inhibitors, bile acid sequestrants) within 6 months of study initiation for&#xD;
             asymptomatic volunteers or within 2 days before study initiation for IBS patients&#xD;
&#xD;
          -  Any females who are pregnant or trying to become pregnant or breast-feeding&#xD;
&#xD;
          -  Antibiotic usage within 3 months prior to study participation&#xD;
&#xD;
          -  Prebiotic or probiotic usage within the 2 weeks prior to study initiation&#xD;
&#xD;
          -  Use of tobacco products within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Shin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Huiping Xu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel 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/NCT02981888
org study id: 1606244063
nct id: NCT02981888
lead sponsor: 
has dmc: No
The purpose of this study is to find out the relationship between the bile acids, fatty acids
      (fatty acids are part of the diet) and bacteria that are present in the intestines.
There is emerging evidence that alterations in bile acids and SCFA associated with IBS could
      be associated with changes in the gut microbiota. In addition to modulating levels of
      intraluminal organic acids, it has been hypothesized that gut microbiota may alter local
      immune responses, modulate visceral pain responses, and impair gut barrier function.

      Our overall goal is to investigate the relationship between fecal bile acids, SCFA and the
      gut microbiota in IBS. Results of this pilot study could reveal insights into the interplay
      of the gut microbiota and small molecule mediators of IBS to suggest targeted clinical
      strategies for improved diagnosis and management of this important syndrome.

      AIM 1: Test the hypothesis that fecal organic acids (SFCA and bile acids) and fecal
      microbiota play an important role in IBS.

      AIM 2: Test the hypothesis that there is association between colonic transit and fecal
      microbiota in IBS
observational model: Case-Control
time perspective: Prospective
measure: Total and individual fecal bile acid excretion
time frame: two days
description: Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry
measure: Total fecal excretion of short chain fatty acids
time frame: two days
description: Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
measure: Fecal microbial population and community from stool collection
time frame: two days
description: Stool samples will be be collected from participants for nucleic acid extraction, 16S allele PCR and sequencing to measure microbial communities and profiles of specimens
measure: Fecal excretion of individual short chain fatty acids
time frame: two days
description: Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
measure: Stool characteristics
time frame: 14 days
description: Stool characteristics will be measured using a 14 day bowel diary
measure: Overall and segmental colon transit
time frame: 7 days
description: Colonic transit time will be measured in days using radiopaque markers
arm group label: IBS-C
description: all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit
arm group label: IBS-D
description: all patients with IBS-D will undergo an abdominal x-ray for assessment of colonic transit
arm group label: heathy control
description: all healthy controls will undergo an abdominal x-ray for assessment of colonic transit
intervention type: Radiation
intervention name: X-Ray
description: X-ray of the abdomen will be performed to assess colonic transit
arm group label: IBS-C
arm group label: IBS-D
arm group label: heathy control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Shin, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Huiping Xu
investigator title: Associate Professor
mesh term: Irritable Bowel Syndrome