The objective of the Pediatric Gastroparesis Registry 2 is to create a national prospective registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).
Who can participate
Age range8 Years – 25 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated informed consent form and assent, as age appropriate.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* 8 to 25 years of age at the time of enrollment
* Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:
nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain
* Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg Beaters protocol (or equivalent generic liquid egg white meal) within the last 12 months who fall into one of the two categories:
* Delayed gastric emptying-defined as an abnormal 2-hour (\>60% retention) and/or 4- hour (\>10% retention) result based on a 4-hour scintigraphic gastric emptying study
* Gastric emptying that is not delayed but who have symptoms of Gp (designated in this study as GLS) or have previously participated in the Pediatric Gastroparesis Registry (PGpR) study
* An etiology of either diabetic or idiopathic Gp or GLS
Exclusion Criteria:
* Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)
* Pregnancy
* Autism spectrum disorder, significant developmental delay, psychosis (because of inability to complete questionnaires)
* Use of narcotic analgesics greater than three days per week.
* Presence of conditions associated with GI mucosal disease (e.g., inflammatory bow…
What they're measuring
1
Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scalesâ„¢
Timeframe: Baseline, 48 weeks
Trial details
NCT IDNCT05981300
SponsorJohns Hopkins Bloomberg School of Public Health