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/NCT06032117</url>
    </required_header>
    <id_info>
      <org_study_id>1891300</org_study_id>
      <nct_id>NCT06032117</nct_id>
    </id_info>
    <brief_title>Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome</brief_title>
    <official_title>Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Nevada, Reno</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Nevada, Reno</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>
        The investigators will characterize and compare protein signatures between groups with and&#xD;
        without post-infection irritable bowel syndrome (PI-IBS). From previous Healthy Nevada&#xD;
        Project (HNP) participants, at least 60 patients with PI-IBS and 60 healthy controls will&#xD;
        undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The&#xD;
        investigators will use proteomic testing to detect, quantify and characterize serum protein&#xD;
        biomarkers and protein signatures, and compare biomarkers and signatures between the patient&#xD;
        groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples&#xD;
        will first undergo protein digestion, then peptides are separated using liquid chromatography&#xD;
        (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo&#xD;
        Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and&#xD;
        data analysis will be performed using Spectronaut software (Biognosys, Schlieren,&#xD;
        Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during&#xD;
        the data analyses comparing biomarkers and signatures between the patient groups of interest.&#xD;
        This research aim has the potential to add to our understanding of the underlying mechanisms&#xD;
        of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose&#xD;
        PI-IBS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators will characterize and compare protein signatures between groups with and&#xD;
        without PI-IBS. From previous HNP participants, at least 60 patients with PI-IBS and 60&#xD;
        healthy controls will be recruited to undergo additional proteomics testing, age, sex and&#xD;
        race/ethnicity-matched healthy. The investigators will use proteomic testing to detect,&#xD;
        quantify and characterize serum protein biomarkers and protein signatures, and compare&#xD;
        biomarkers and signatures between the patient groups of interest. Serum samples will be&#xD;
        analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then&#xD;
        peptides are separated using liquid chromatography (LC), mass spectral analysis is performed&#xD;
        using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using&#xD;
        data-independent acquisition (DIA). Library generation and data analysis will be performed&#xD;
        using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center&#xD;
        and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and&#xD;
        signatures between the patient groups of interest. This research aim has the potential to add&#xD;
        to our understanding of the underlying mechanisms of PI-IBS and to create reliable&#xD;
        differentiating protein biomarkers to better diagnose PI-IBS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 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>Rome IV diagnosis of post-infectious irritable bowel syndrome</measure>
      <time_frame>Day 1</time_frame>
      <description>Rome IV is used to diagnose IBS, and participants must additionally have had sudden onset of their IBS with either 1) IBS symptoms developing immediately AFTER foreign travel/deployment or 2) immediately AFTER acute infectious gastroenteritis with two or more of: fever, vomiting, diarrhea</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Participant-reported post-infectious irritable bowel syndrome</measure>
      <time_frame>Day 1</time_frame>
      <description>Participants report that they have been diagnosed with IBS by a physician and that they still have symptoms, and participants must additionally have had sudden onset of their IBS with either 1) IBS symptoms developing immediately AFTER foreign travel/deployment or 2) immediately AFTER acute infectious gastroenteritis with two or more of: fever, vomiting, diarrhea</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Post-infectious Irritable Bowel Syndrome</condition>
    <condition>Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>Post infectious irritable bowel syndrome group</arm_group_label>
      <description>Participants will have post-infectious IBS (as identified via Rome IV criteria or previous physician diagnosis)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy control group</arm_group_label>
      <description>Participants will not have post-infectious IBS, matched on age group, sex, and race/ethnicity.</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Approximately 6 ml of blood will be collected from each participant. Samples will be&#xD;
        centrifuged (1,000-2,000 x g for 10 minutes), the serum separated and placed into an&#xD;
        Eppendorf tube/cryovials, and stored in a -80 °C fridge until analysis. The proteomics lab&#xD;
        will use 100ul of serum, and the rest will be banked in cryovials. The de-identified samples&#xD;
        will be stored in a fridge at UNR, which is in a locked room and accessible only to the&#xD;
        University of Nevada, Reno (UNR) research team. The researchers will not identify these&#xD;
        samples or perform identifying tests (e.g., genetics tests) on those samples. The samples&#xD;
        will be stored for a period of 3 years.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          To approximate the population of Washoe county in our recruitment survey we will use a&#xD;
          stratified random sampling scheme to randomly sample from strata of sex and ethnicity from&#xD;
          within the HNP, so that our study sample is approximately 50% male and 50% female, and&#xD;
          approximately 24.5% Hispanic. From these survey responses, the PI will be able to find 60&#xD;
          PI-IBS cases, and 60 controls. We will send the recruitment email to additional&#xD;
          participants following the same methods described above (e.g., batching 1000 potential&#xD;
          participants at a time, oversampling Hispanics and women in the same way) until we have&#xD;
          found 60 total PI-IBS participants. If we have further difficulties finding PI-IBS&#xD;
          participants, we will send targeted emails to anyone in HNP who has an ICD 10 code&#xD;
          indicating a gastrointestinal infection in the last 5 years.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants must have a Healthy Nevada Project record and linked Renown Health&#xD;
               medical record&#xD;
  &#xD;
            -  Must be at least 18 years of age&#xD;
  &#xD;
            -  Must have previously consented to being contacted and have updated contact information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joshua Garn, PhD</last_name>
      <phone>(775) 682-6996</phone>
      <email>jgarn@unr.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Final study results will be posted to ClinicalTrials.gov within 12 months of study completion.&#xD;
  The study protocol and statistical analysis plans will be shared on Open Science Framework (OSF) before the first biological samples are collected.&#xD;
  The informed consent form will be posted to OSF within 60 days of the last study visit by any participant.&#xD;
  Analytic code and relevant data will be posted to OSF upon publication of study results.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_url>https://osf.io/2z4rj/</ipd_url>
    </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/NCT06032117
  org study id: 1891300
  nct id: NCT06032117
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will characterize and compare protein signatures between groups with and
        without post-infection irritable bowel syndrome (PI-IBS). From previous Healthy Nevada
        Project (HNP) participants, at least 60 patients with PI-IBS and 60 healthy controls will
        undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The
        investigators will use proteomic testing to detect, quantify and characterize serum protein
        biomarkers and protein signatures, and compare biomarkers and signatures between the patient
        groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples
        will first undergo protein digestion, then peptides are separated using liquid chromatography
        (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo
        Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and
        data analysis will be performed using Spectronaut software (Biognosys, Schlieren,
        Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during
        the data analyses comparing biomarkers and signatures between the patient groups of interest.
        This research aim has the potential to add to our understanding of the underlying mechanisms
        of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose
        PI-IBS.
  The investigators will characterize and compare protein signatures between groups with and
        without PI-IBS. From previous HNP participants, at least 60 patients with PI-IBS and 60
        healthy controls will be recruited to undergo additional proteomics testing, age, sex and
        race/ethnicity-matched healthy. The investigators will use proteomic testing to detect,
        quantify and characterize serum protein biomarkers and protein signatures, and compare
        biomarkers and signatures between the patient groups of interest. Serum samples will be
        analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then
        peptides are separated using liquid chromatography (LC), mass spectral analysis is performed
        using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using
        data-independent acquisition (DIA). Library generation and data analysis will be performed
        using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center
        and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and
        signatures between the patient groups of interest. This research aim has the potential to add
        to our understanding of the underlying mechanisms of PI-IBS and to create reliable
        differentiating protein biomarkers to better diagnose PI-IBS.
  observational model: Case-Control
  time perspective: Prospective
  measure: Rome IV diagnosis of post-infectious irritable bowel syndrome
  time frame: Day 1
  description: Rome IV is used to diagnose IBS, and participants must additionally have had sudden onset of their IBS with either 1) IBS symptoms developing immediately AFTER foreign travel/deployment or 2) immediately AFTER acute infectious gastroenteritis with two or more of: fever, vomiting, diarrhea
  measure: Participant-reported post-infectious irritable bowel syndrome
  time frame: Day 1
  description: Participants report that they have been diagnosed with IBS by a physician and that they still have symptoms, and participants must additionally have had sudden onset of their IBS with either 1) IBS symptoms developing immediately AFTER foreign travel/deployment or 2) immediately AFTER acute infectious gastroenteritis with two or more of: fever, vomiting, diarrhea
  arm group label: Post infectious irritable bowel syndrome group
  description: Participants will have post-infectious IBS (as identified via Rome IV criteria or previous physician diagnosis)
  arm group label: Healthy control group
  description: Participants will not have post-infectious IBS, matched on age group, sex, and race/ethnicity.
  Approximately 6 ml of blood will be collected from each participant. Samples will be
        centrifuged (1,000-2,000 x g for 10 minutes), the serum separated and placed into an
        Eppendorf tube/cryovials, and stored in a -80 °C fridge until analysis. The proteomics lab
        will use 100ul of serum, and the rest will be banked in cryovials. The de-identified samples
        will be stored in a fridge at UNR, which is in a locked room and accessible only to the
        University of Nevada, Reno (UNR) research team. The researchers will not identify these
        samples or perform identifying tests (e.g., genetics tests) on those samples. The samples
        will be stored for a period of 3 years.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joshua Garn, PhD
  phone: (775) 682-6996
  email: jgarn@unr.edu
  responsible party type: Sponsor
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd description: Final study results will be posted to ClinicalTrials.gov within 12 months of study completion.
  The study protocol and statistical analysis plans will be shared on Open Science Framework (OSF) before the first biological samples are collected.
  The informed consent form will be posted to OSF within 60 days of the last study visit by any participant.
  Analytic code and relevant data will be posted to OSF upon publication of study results.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd url: https://osf.io/2z4rj/