Indiana University Gastrointestinal Motility Diagnosis Registry

NCT04506593 | Recruiting

• 2 other identifiers: GI Database1403899260
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux Disease (GERD); Gastroparesis; Functional Vomiting; Irritable Bowel Syndrome (IBS); Constipation; Chronic Intestinal Pseudo-obstruction; Fecal Incontinence; Small Intestinal Bacterial Overgrowth

Keywords

Eosinophilic esophagitis; Chronic intestinal pseudo-obstruction; Small Bowel dysmotility; SIBO; Vomiting; Functional dyspepsia; Functional bloating; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Identification of patients by accurate motility diagnosis

  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 Outcomes (2)

• Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)

  through study completion, an average of 10 years

• Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis

  through study completion, an average of 10 years

Interventions

no intervention OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastroesophageal Reflux; Gastroparesis; Irritable Bowel Syndrome; Constipation; Fecal Incontinence; Vomiting

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Rectal Diseases

Study Officials

• John m Wo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lainna Cohen

CONTACT

3172780621; larcohen@iu.edu

Maureen Schilling

CONTACT

maschi@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Douglas Rex Professor of Gastroenterology and Hepatology; Director of GI Motility and Neurogastroenterology Unit

Study Record Dates

• First Submitted: July 16, 2016
• First Posted: August 10, 2020
• Study Start: November 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)