Indiana University Gastrointestinal Motility Diagnosis Registry

Constipation Clinical Trial

Official title:

Gastrointestinal Motility Diagnosis Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506593
• Other study ID #: GI Database
• Secondary ID: 1403899260
• Status: Recruiting
• Start date: November 2014
• Est. completion date: November 2024

Study information

• Verified date: February 2022
• Source: Indiana University
• Contact: Megan Jarrett
• Email: mrattin[@]iu.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)	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
Secondary	Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis	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