Gastroparesis Registry 4 (GpR4)

Johns Hopkins Bloomberg School of Public Health

Status

Enrolling

Conditions

Gastroparesis

Gastroparesis Due to Diabetes Mellitus Type I

Functional Disorder of Gastrointestinal Tract

Gastro-Intestinal Disorder

Gastroparesis Due to Diabetes Mellitus Type II

Gastroparesis Nondiabetic

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05846802

U01DK073974 (U.S. NIH Grant/Contract)

U01DK073983 (U.S. NIH Grant/Contract)

IRB00401119 (Other Identifier)

14-DK-GpR4

U24DK074008 (U.S. NIH Grant/Contract)

U01DK074007 (U.S. NIH Grant/Contract)

U01DK073975 (U.S. NIH Grant/Contract)

U01DK112193 (U.S. NIH Grant/Contract)

U01DK074035 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This observational study of patients with symptoms of gastroparesis (Gp) and functional dyspepsia (FD) with either delayed or normal gastric emptying aims to assess the clinical, pathophysiological, and psychological similarities and differences between patients with Gp, FD.

The primary outcome will be the measure of symptom severity of gastroparesis and functional dyspepsia using the change in total score from the Patient Assessment of Upper Gastrointestinal Disorders Symptoms (PAGI SYM) from baseline to 48 weeks.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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