Pediatric Gastroparesis Registry

Completed

Conditions studied: Gastroparesis, Gastroparesis-like Syndrome

In brief

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).

Key facts

Study ID

NCT03680820

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

147

Starts

2019-01-23

Expected to finish

2024-06-30

Last updated by the study team

2024-07-10

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Inability to comply with or complete the scintigraphic gastric emptying test (including allergy to eggs)
• Pregnancy
• 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)
• Use of narcotic analgesics greater than three days per week
• Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis)
• 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)
• Clinically significant congenital heart disease (i.e., vagal injury during cardiac repair)
• History of esophageal, gastric or bowel surgery excepting prior fundoplication
• 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)
• Use of medications that can affect motility during the gastric emptying study
• Any other condition, which in the opinion of the investigator, could explain the symptoms or interfere with study requirements
• Inability to obtain informed consent/assent

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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