<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/NCT04506593</url>
  </required_header>
  <id_info>
    <org_study_id>GI Database</org_study_id>
    <secondary_id>1403899260</secondary_id>
    <nct_id>NCT04506593</nct_id>
  </id_info>
  <brief_title>Indiana University Gastrointestinal Motility Diagnosis Registry</brief_title>
  <official_title>Gastrointestinal Motility Diagnosis Registry</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Develop a registry (list of patients) with accurate clinical motility diagnosis. This&#xD;
      registry will help the doctors to identify the patients with specific disease conditions. It&#xD;
      will also help in promoting future research in gastroenterology motility disorders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Develop a registry (list of patients) of patients seen the clinics with motility disorders.&#xD;
      Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis&#xD;
      will be made by physicians with specialized in GI Motility, based on clinical consensus of&#xD;
      diagnostic criteria. The information gathered from the database will be used to help promote&#xD;
      future clinical research in the GI motility and Neurogastroenterology Unit at Indiana&#xD;
      University School of Medicine.&#xD;
&#xD;
      Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems,&#xD;
      such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension,&#xD;
      weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is&#xD;
      essential in order to promote cost-effective treatment and future research to benefit&#xD;
      patients with GI motility disorders&#xD;
&#xD;
      Specific Aims&#xD;
&#xD;
        1. Primary Aim: Identification of patients by accurate motility diagnosis&#xD;
&#xD;
        2. Secondary Aims:&#xD;
&#xD;
             1. To develop Patient Reported Outcome (PRO) measurements in patients with small&#xD;
                intestinal bacterial overgrowth (SIBO)&#xD;
&#xD;
             2. To develop Patient Reported Outcome (PRO) measurements in patients with&#xD;
                gastroparesis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Identification of patients by accurate motility diagnosis</measure>
    <time_frame>.through study completion, an average of 10 years</time_frame>
    <description>Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)</measure>
    <time_frame>through study completion, an average of 10 years</time_frame>
    <description>SIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis</measure>
    <time_frame>through study completion, an average of 10 years</time_frame>
    <description>Patient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Eosinophilic Esophagitis</condition>
  <condition>Gastroesophageal Reflux Disease (GERD)</condition>
  <condition>Gastroparesis</condition>
  <condition>Functional Vomiting</condition>
  <condition>Irritable Bowel Syndrome (IBS)</condition>
  <condition>Constipation</condition>
  <condition>Chronic Intestinal Pseudo-obstruction</condition>
  <condition>Fecal Incontinence</condition>
  <condition>Small Intestinal Bacterial Overgrowth</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All Patients who presented to the GI outpatient clinics, in-patient consult service, and&#xD;
        outpatient endoscopy centers within the Division of Gastroenterology and Hepatology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who presented to the GI outpatient clinics, in-patient consult service, and&#xD;
             outpatient endoscopy centers within the Division of Gastroenterology and Hepatology&#xD;
&#xD;
          2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in&#xD;
             table&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Coexisting medical conditions that may limiting participation in clinical research trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John m Wo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Megan Jarrett</last_name>
    <email>mrattin@iu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kara Murphy</last_name>
    <email>clarkara@iu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Jarrett, MBBS, MPH</last_name>
      <email>mrattin@iu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Kara Murphy</last_name>
      <email>clarkara@iu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Thomas V Nowak, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Wo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joel Wittles, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Shin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anita Gupta, MBBS, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Siwiec, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>William Kessler, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Toyia J Stevenson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Akira Saito, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Montero, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 16, 2016</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>February 11, 2022</last_update_submitted>
  <last_update_submitted_qc>February 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>John M. Wo</investigator_full_name>
    <investigator_title>Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit</investigator_title>
  </responsible_party>
  <keyword>Eosinophilic esophagitis</keyword>
  <keyword>Chronic intestinal pseudo-obstruction</keyword>
  <keyword>Small Bowel dysmotility</keyword>
  <keyword>SIBO</keyword>
  <keyword>Vomiting</keyword>
  <keyword>Functional dyspepsia</keyword>
  <keyword>Functional bloating</keyword>
  <keyword>Gastroparesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis</mesh_term>
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Eosinophilic Esophagitis</mesh_term>
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Intestinal Pseudo-Obstruction</mesh_term>
    <mesh_term>Constipation</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>observational registry</ipd_description>
  </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/NCT04506593
org study id: GI Database
secondary id: 1403899260
nct id: NCT04506593
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Develop a registry (list of patients) with accurate clinical motility diagnosis. This
      registry will help the doctors to identify the patients with specific disease conditions. It
      will also help in promoting future research in gastroenterology motility disorders
Develop a registry (list of patients) of patients seen the clinics with motility disorders.
      Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis
      will be made by physicians with specialized in GI Motility, based on clinical consensus of
      diagnostic criteria. The information gathered from the database will be used to help promote
      future clinical research in the GI motility and Neurogastroenterology Unit at Indiana
      University School of Medicine.

      Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems,
      such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension,
      weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is
      essential in order to promote cost-effective treatment and future research to benefit
      patients with GI motility disorders

      Specific Aims

        1. Primary Aim: Identification of patients by accurate motility diagnosis

        2. Secondary Aims:

             1. To develop Patient Reported Outcome (PRO) measurements in patients with small
                intestinal bacterial overgrowth (SIBO)

             2. To develop Patient Reported Outcome (PRO) measurements in patients with
                gastroparesis
observational model: Cohort
time perspective: Prospective
measure: Identification of patients by accurate motility diagnosis
time frame: .through study completion, an average of 10 years
description: Motility diagnosis will be made by physicians with specialized in GI Motility, based on consensus diagnostic criteria. The information gathered from the database will be used to help promote future clinical development and research in GI motility disorders.
measure: Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)
time frame: through study completion, an average of 10 years
description: SIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO
measure: Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis
time frame: through study completion, an average of 10 years
description: Patient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.
intervention type: Other
intervention name: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: John m Wo, MD
role: Principal Investigator
affiliation: Indiana University
last name: Megan Jarrett
email: mrattin@iu.edu
last name: Kara Murphy
email: clarkara@iu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: John M. Wo
investigator title: Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit
mesh term: Irritable Bowel Syndrome
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis
mesh term: Gastroparesis
mesh term: Eosinophilic Esophagitis
mesh term: Fecal Incontinence
mesh term: Intestinal Pseudo-Obstruction
mesh term: Constipation
mesh term: Vomiting
sharing ipd: No
ipd description: observational registry