Clinical trial NCT04506593: Indiana University Gastrointestinal Motility Diagnosis Registry
Official title: Gastrointestinal Motility Diagnosis Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: 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

Primary outcomes:
measure: Identification of patients by accurate motility diagnosis
timeFrame: .through study completion, an average of 10 years
Secondary outcomes:
measure: Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)
timeFrame: through study completion, an average of 10 years
measure: Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: John m Wo, MD
role: PRINCIPAL_INVESTIGATOR
References: