GpCRC Pediatric Gastroparesis Registry 2

A vizsgálat adatai

Ki végzi

Johns Hopkins Bloomberg School of Public Health

Azonosító

NCT05981300

A regiszteradat frissítve

2026. április 3.

Eredeti leírás

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).A teljes eredeti leírásKevesebb

GpCRC Pediatric Gastroparesis Registry 2: Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants With Symptoms of Gastroparesis

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).

Bevonási feltételek: 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.

Kizáró feltételek: 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 (because of inability to complete questionnaires); Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric ulcer, peptic ulcer, celiac disease); Presence of any other condition that could case delayed gastric emptying; Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious legions; Acute liver failure; Advanced liver disease (features of portal hypertension); Clinically significant congenital heart disease (i.e., vaginal injury during cardiac repair); History of esophageal, gastric or bowel surgery; Metabolic disease including mitochondrial disease and inborn errors of metabolism; Chronic lung disease (including cystic fibrosis); A serious chronic medical condition (e.g., inflammatory bowel disease); Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements; Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysis or peritoneal dialysis; Pregnancy; Use of narcotic analgesics greater than three days per week; Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT.

ClinicalTrials.gov NCT05981300