Gastroparesis Registry 4

Description

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.

Conditions

Gastroparesis, Gastroparesis Nondiabetic, Gastroparesis Due to Diabetes Mellitus Type I, Gastroparesis Due to Diabetes Mellitus Type II, Functional Disorder of Gastrointestinal Tract, Gastro-Intestinal Disorder

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Study Overview

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Study Details

Study overview

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.

Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia

Gastroparesis Registry 4

Condition
Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Jay Pasricha, Scottsdale, Arizona, United States, 85259

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Charlotte

Wake Forest University and Atrium Health Carolinas Medical Center, Charlotte, North Carolina, United States, 28202

Philadelphia

Temple University Hospital, Philadelphia, Pennsylvania, United States, 19140

El Paso

Texas Tech University Health Science Center (TTUHSC), El Paso, Texas, United States, 79905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 6 months
  • * Negative upper endoscopy or upper radiographic GI series within 2 years of registration
  • * Use of narcotic analgesics greater than three days per week
  • * Presence of other conditions that could explain the patient's symptoms such as:
  • * Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
  • * Active inflammatory bowel disease
  • * Known eosinophilic gastroenteritis or eosinophilic esophagitis
  • * Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
  • * Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
  • * Acute liver failure or advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7)
  • * Pancreatic disorder if present on pancreatic imaging or pancreatic function testing
  • * Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
  • * Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
  • * Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
  • * Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
  • * Inability to obtain informed consent

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins Bloomberg School of Public Health,

Jay Pasricha, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Henry Parkman, MD, PRINCIPAL_INVESTIGATOR, Temple University

David Shade, JD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

2027-04-30