Indiana University Gastrointestinal Motility Diagnosis Registry

Recruiting

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

• Registration Number: NCT04506593
• Lead Sponsor: 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

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-07-16
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Indiana University Health University Hospital; 🇺🇸 Indianapolis, Indiana, United States