Gastroparesis Registry 4

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · May 4, 2023

Keywords

ClinConnect Summary

The Gastroparesis Registry 4 (GpR4) is a study designed to learn more about two conditions: gastroparesis, which affects how the stomach empties, and functional dyspepsia, which involves discomfort in the upper stomach. This research aims to gather information about patients' backgrounds, symptoms, and treatment outcomes by having participants complete questionnaires, take a special nutrient drink test, and undergo a gastric emptying study. The goal is to better understand these conditions and how they affect people over time.

To join the study, you need to be at least 18 years old and have experienced symptoms like nausea, vomiting, or abdominal pain for at least 12 weeks. You’ll also need to have undergone a specific test to check how quickly your stomach empties within the last six months. However, certain factors might make you ineligible, such as recent serious health issues, pregnancy, or if you've had specific surgeries on your stomach. If you decide to participate, you will play an important role in helping researchers improve the understanding and treatment of these gastrointestinal disorders.

Gender

ALL

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 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