About this trial

The Gastroparesis Registry 4 (GpR4) is an observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the patients and their clinical course. Participants will complete several questionnaires, complete a nutrient drink test and have a gastric emptying study.

Eligibility criteria

Qualifiers

Age at least 18 years at initial screening visit

Symptoms of Gp and/or FD of at least 12-weeks duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness, abdominal pain, abdominal burning. Thus, patients can enter the GpR4 registry primarily with abdominal pain suggesting FD-Epigastric Pain Syndrome.

Successful completion of gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 9 months

Negative upper endoscopy or upper radiographic GI series within 5 years of registration

Disqualifiers

Use of narcotic analgesics greater than three days per week

Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT

Active inflammatory bowel disease

Known eosinophilic gastroenteritis or eosinophilic esophagitis

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

250 Participants
are grouped into 2 trial groups

Locations

6
Arizona
Jay Pasricha85259, Scottsdale United States
Kentucky
University of Louisville40202, Louisville United States
Massachusetts
Massachusetts General Hospital02114, Boston United States
North Carolina
Wake Forest University and Atrium Health Carolinas Medical Center28202, Charlotte United States

Sponsors and collaborators

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Collaborator

Temple University

Collaborator

University of Louisville

Collaborator

Mayo Clinic

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Massachusetts General Hospital

Collaborator

Wake Forest University

Collaborator