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Indiana University Gastrointestinal Motility Diagnosis Registry

Gastrointestinal Motility Diagnosis Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04506593
Enrollment
5000
Registered
2020-08-10
Start date
2014-11-01
Completion date
2026-11-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

Interventions

OTHERno intervention

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Identification of patients by accurate motility diagnosis.through study completion, an average of 10 yearsMotility 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

MeasureTime frameDescription
Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)through study completion, an average of 10 yearsSIBO-disease specific patient questionnaire will be compared between patients with aerodigestive tract SIBO and coliform SIBO
Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesisthrough study completion, an average of 10 yearsPatient Assessment of GI - Symptom (PAGI-SYM) scores will be compared between patients with emesis-predominant, dyspeptic-predominant, and regurgitation-predominant gastroparesis.

Countries

United States

Contacts

CONTACTLainna Cohen
larcohen@iu.edu3172780621
CONTACTMaureen Schilling
maschi@iu.edu
PRINCIPAL_INVESTIGATORJohn m Wo, MD

Indiana University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026