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Indiana University Gastrointestinal Motility Diagnosis Registry

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ClinicalTrials.gov Identifier: NCT04506593
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
John M. Wo, Indiana University

Brief Summary:
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

Condition or disease Intervention/treatment
Eosinophilic Esophagitis Gastroesophageal Reflux Disease (GERD) Gastroparesis Functional Vomiting Irritable Bowel Syndrome (IBS) Constipation Chronic Intestinal Pseudo-obstruction Fecal Incontinence Small Intestinal Bacterial Overgrowth Other: no intervention

Detailed Description:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Gastrointestinal Motility Diagnosis Registry
Study Start Date : November 2014
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024





Primary Outcome Measures :
  1. Identification of patients by accurate motility diagnosis [ Time Frame: .through study completion, an average of 10 years ]
    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.


Secondary Outcome Measures :
  1. Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO) [ Time Frame: through study completion, an average of 10 years ]
    SIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO

  2. Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis [ Time Frame: through study completion, an average of 10 years ]
    Patient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
Criteria

Inclusion Criteria:

  1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
  2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table

Exclusion Criteria:

1. Coexisting medical conditions that may limiting participation in clinical research trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04506593


Contacts
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Contact: Anita Gupta, MBBS,CCRC 3179489227 anigupta@iu.edu
Contact: Megan Rattin mrattin@iu.edu

Locations
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United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta, MBBS, MPH    317-948-9227    anigupta@iu.edu   
Sub-Investigator: Thomas V Nowak, MD         
Principal Investigator: John Wo, MD         
Sub-Investigator: Joel Wittles, MD         
Sub-Investigator: Andrea Shin, MD         
Sub-Investigator: Anita Gupta, MBBS, MPH         
Sub-Investigator: Robert Siwiec, MD         
Sub-Investigator: William Kessler, MD         
Sub-Investigator: Toyia J Stevenson, MD         
Sub-Investigator: Akira Saito, MD         
Sub-Investigator: Anne Montero, PhD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: John m Wo, MD Indiana University
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Responsible Party: John M. Wo, Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit, Indiana University
ClinicalTrials.gov Identifier: NCT04506593    
Other Study ID Numbers: GI Database
1403899260 ( Other Identifier: Indiana University IRB )
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: observational registry

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John M. Wo, Indiana University:
Eosinophilic esophagitis
Chronic intestinal pseudo-obstruction
Small Bowel dysmotility
SIBO
Vomiting
Functional dyspepsia
Functional bloating
Gastroparesis
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Gastroesophageal Reflux
Esophagitis
Gastroparesis
Eosinophilic Esophagitis
Fecal Incontinence
Intestinal Pseudo-Obstruction
Constipation
Vomiting
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastroenteritis
Stomach Diseases
Paralysis
Neurologic Manifestations
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Rectal Diseases
Ileus