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Gastroparesis Registry 4
NCT05846802 · Johns Hopkins Bloomberg School of Public Health
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
About this study
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.
Eligibility criteria
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 9 months
* Negative upper endoscopy or upper radiographic GI series within 5 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
Study design
Enrollment target: 250 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-09-20
Estimated completion: 2027-04-30
Last updated: 2026-04-03
Primary outcomes
- • 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. (48 weeks)
Sponsor
Johns Hopkins Bloomberg School of Public Health · other
With: Texas Tech University Health Sciences Center, El Paso, Temple University, University of Louisville, Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Massachusetts General Hospital, Wake Forest University
Contacts & investigators
ContactLaura Miriel · contact · lmiriel1@jhu.edu · 4435024165
ContactEmily Mitchell, MS, MBA · contact · esharke5@jhu.edu
InvestigatorJay Pasricha, MD · principal_investigator, Mayo Clinic
InvestigatorHenry Parkman, MD · principal_investigator, Temple University
InvestigatorDavid Shade, JD · principal_investigator, Johns Hopkins Bloomberg School of Public Health
All locations (6)
Jay PasrichaRecruiting
Scottsdale, Arizona, United States
University of LouisvilleRecruiting
Louisville, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Wake Forest University and Atrium Health Carolinas Medical CenterRecruiting
Charlotte, North Carolina, United States
Temple University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Texas Tech University Health Science Center (TTUHSC)Recruiting
El Paso, Texas, United States