Indiana University Gastrointestinal Motility Diagnosis Registry

February 11, 2022 updated by: John M. Wo, Indiana University

Gastrointestinal Motility Diagnosis Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Hospital
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
.through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 10 years
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.
through study completion, an average of 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: John M Wo, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

July 16, 2016

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI Database
  • 1403899260 (Other Identifier: Indiana University IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

observational registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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