NCT05846802Recruiting
Gastroparesis Registry 4
Gastroparesis Registry 4 (GpR4): Improving the Understanding of Gastroparesis and Functional Dyspepsia
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 25 Apr 2023
- Start date
- 20 Sept 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05846802
What you commit to
- Study type: Observational
- Planned participants: 250
- From 20 Sept 2024 to the primary completion date, 30 Apr 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior gastric surgery including total or subtotal (near complete) gastric resection, esophagectomy, gastrojejunostomy, gastric bypass, gastric sleeve, pyloroplasty, pyloromyotomy, or any fundoplication (Nissen, Tor)
- Females who are pregnant. A urine pregnancy test is routinely obtained on all females immediately prior to gastric emptying procedures.
Other illness
- Presence of other conditions that could explain the patient's symptoms such as:
- Active inflammatory bowel disease
- Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
- 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
- Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
- Inability to comply with or complete the gastric emptying scintigraphy test (including allergy to eggs)
Lab values
- Acute or chronic renal failure (serum creatinine \>3 mg/dL) and/or on hemodialysis or peritoneal dialysis
Other
- Use of narcotic analgesics greater than three days per week
- Pyloric or intestinal obstruction as evidenced by EGD, UGI, or Abdominal CT
- Known eosinophilic gastroenteritis or eosinophilic esophagitis
- Inability to obtain informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Wake Forest University and Atrium Health Carolinas Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Texas Tech University Health Science Center (TTUHSC) Coordinator of this site? Confirm its status | El Paso | United States | Recruiting |
| University of Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Temple University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Jay Pasricha Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.