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NCT Number: NCT04506593

Indiana University Gastrointestinal Motility Diagnosis Registry

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

Recruiting

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Key information

Conditions

Eosinophilic Esophagitis Chronic Intestinal Pseudo-obstruction Colonic Diseases Colonic Diseases, Functional Constipation Deglutition Disorders Digestive System Diseases Eosinophilia Esophageal Diseases Esophageal Motility Disorders Esophagitis Fecal Incontinence Functional Vomiting Gastroenteritis Gastroesophageal Reflux Gastroesophageal Reflux Disease (GERD) Gastrointestinal Diseases Gastroparesis Hematologic Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Intestinal Diseases Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) Leukocyte Disorders Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive Small Intestinal Bacterial Overgrowth Stomach Diseases Vomiting

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Akira Saito, MD

SUB_INVESTIGATOR

Anne Montero, PhD

SUB_INVESTIGATOR

Joel Wittles, MD

SUB_INVESTIGATOR

John Wo, MD

PRINCIPAL_INVESTIGATOR

Maureen Schilling, BA

CONTACT

[email protected]

317-278-2064

Robert Siwiec, MD

SUB_INVESTIGATOR

Thomas V Nowak, MD

SUB_INVESTIGATOR

Toyia J Stevenson, MD

SUB_INVESTIGATOR

About this study

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

  • Primary Aim: Identification of patients by accurate motility diagnosis
  • Secondary Aims:
  • To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)
  • To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Coexisting medical conditions that may limiting participation in clinical research trial

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Identification of patients by accurate motility diagnosis

    Time frame: .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 outcomes

  1. Patient Reported Outcome (PRO) Measurements in Patients with Small Intestinal Bacterial Overgrowth (SIBO)

    Time frame: 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

  2. Patient Reported Outcome (PRO) Measurements in Patients with Gastroparesis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lainna Cohen

CONTACT

[email protected]

3172780621

Maureen Schilling

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Gastrointestinal Motility Diagnosis Registry

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2020
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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