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Recruiting NCT04506593

Indiana University Gastrointestinal Motility Diagnosis Registry

Observational Eosinophilic Esophagitis Gastroesophageal Reflux Disease (GERD) Gastroparesis Functional Vomiting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no intervention.
Who it may be relevant to
Registry conditions: Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD), Gastroparesis, Functional Vomiting. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Gastrointestinal Motility Diagnosis Registry

Overview

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

  • Other no intervention

Primary outcome measures

  • Identification of patients by accurate motility diagnosis [Time frame: .through study completion, an average of 10 years]
Secondary outcome measures (2)
  • Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO) [Time frame: through study completion, an average of 10 years]
  • Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis [Time frame: through study completion, an average of 10 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Indiana University Health University Hospital — Indianapolis

Identifiers

NCT: NCT04506593 · GI Database · 1403899260

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗