Gastroparesis Registry 4
About this study
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.
- Condition
- 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
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Who can join
- Age
- 18 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 85 years
- Study condition: 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
- 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
Exclusion 14
- 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
Where
6 sites, 6 recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Wake Forest University and Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Texas Tech University Health Science Center (TTUHSC)
El Paso, Texas, United States
University of Louisville
Louisville, Kentucky, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Jay Pasricha
Scottsdale, Arizona, United States
Contact
-
Laura Miriel
4435024165 lmiriel1@jhu.edu
-
Emily Mitchell, MS, MBA
Potential match only. Final eligibility is determined by the study team.