Indiana University Gastrointestinal Motility Diagnosis Registry

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04506593
Collaborator
(none)
5,000
1
120
41.7

Study Details

Study Description

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

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:

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

  4. To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Gastrointestinal Motility Diagnosis Registry
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Identification of patients by accurate motility diagnosis [.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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Indiana University Hospital Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Aug 10, 2020
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John M. Wo, Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022