The purpose of this study is to create a new registry of patients with gastroparesis in order to better understand the characteristics of patients with gastroparesis and follow how their condition changes over time. The data collected may improve the understanding of the condition to enable better diagnosis and treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Symptoms of gastroparesis of at least 12 weeks' duration with varying degrees of nausea, vomiting, early satiety, postprandial fullness
* An etiology of either diabetic, idiopathic, or post-fundoplication (Nissen, Dor, or Toupet) gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying)
* Gastric emptying scintigraphy of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 6 months with either:
* Abnormal gastric emptying rate defined as an abnormal 2 hour (\>60% retention) and/or 4 hour (\>10% retention) result based on a 4 hour scintigraphic gastric emptying study. (This group will comprise \~75% of patients in the registry.)
* Patients with a normal gastric emptying rate, but who have symptoms of gastroparesis. (This group will comprise \~25% of patients in the registry.)
* Negative upper endoscopy or upper radiographic GI series within 2 years of registration
* Age at least 18 years at initial screening visit
Exclusion Criteria:
* Inability to comply with or complete the gastric emptying test by scintigraphy (including allergy to eggs)
* Use of narcotic analgesics greater than three days per week
* Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction: by EGD, UGI, or Abdominal CT
* Active inflammatory bowel disease
* Known eosinophilic gastroenteritis or eosinophilic esophagitis
* Primary neurolog…
What they're measuring
1
Change from baseline GSCI score at 48 weeks
Timeframe: Baseline to 48 weeks
Trial details
NCT IDNCT03680859
SponsorJohns Hopkins Bloomberg School of Public Health