Pediatric Gastroparesis Registry
Key facts
- Where
- Boston, Columbus, and Houston, United StatesSee the 3 sites
Where in United States
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- Baylor College of Medicine/ Texas Children's HospitalHouston, United StatesNo longer taking part
Trial details
- Who runs it
- Johns Hopkins Bloomberg School of Public Health
- Trial code
- NCT03680820
- Record updated
- 10 July 2024
- Original description
The objective of the Pediatric Gastroparesis Registry is to create a national prospective registry of children and adolescents with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).Read full original descriptionShow less
Pediatric Gastroparesis Registry: Pediatric Registry of Patients With Suspected Gastroparesis
The objective of the Pediatric Gastroparesis Registry is to create a national prospective registry of children and adolescents with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).
Inclusion: Cardinal symptoms of gastroparesis of at least 12 weeks duration. Cardinal symptoms of gastroparesis are the constellation of some combination of: nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be accompanied by upper abdominal pain; An etiology of either diabetic, idiopathic, or post-fundoplication gastroparesis or gastroparesis-like disorder (symptoms of gastroparesis but normal gastric emptying; see below); Gastric emptying scintigraphy (GES) of solids using the 4-hour Egg Beaters® protocol (or equivalent generic liquid egg white meal) within the last 12 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); Age at least 5 years, and under 18 years at initial screening visit.
Exclusion: History of esophageal, gastric or bowel surgery excepting prior fundoplication; Use of medications that can affect motility during the gastric emptying study; Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs); Autism spectrum disorder, significant developmental delay, psychosis, or a history of bipolar disorder (because of inability to complete the gastroparesis symptom questionnaires: 24-hour recall and gastroparesis cardinal symptom questionnaire (the latter to be completed during the scintigraphy if possible); Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis); Clinically significant congenital heart disease (i.e., vagal injury during cardiac repair); Metabolic disease including mitochondrial disease and inborn errors of metabolism; Chronic lung disease (including cystic fibrosis); A serious chronic medical condition (e.g., cystic fibrosis); Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements; Presence of any other condition that could cause delayed gastric emptying including:; Gastrointestinal obstruction confirmed by EGD, UGI, or abdominal CT; 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 (abnormal creatinine for age) and/or on hemodialysis or peritoneal dialysis; Acute liver failure; Advanced liver disease (features of portal hypertension); Pregnancy; Use of narcotic analgesics greater than three days per week; Inability to obtain informed consent/assent.