Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT03680820
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. 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)
2. 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 Criteria:
* 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:
1. Gastrointestinal obstruction confirmed by EGD, UGI, or abdominal CT
2. Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
3. Acute or chronic renal failure (abnormal creatinine for age) and/or on hemodialysis or peritoneal dialysis
4. Acute liver failure
5. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT03680820
Study Brief:
Protocol Section:
NCT03680820