Back to Trials
NCT05981300Recruiting

GpCRC Pediatric Gastroparesis Registry 2

Johns Hopkins Bloomberg School of Public Health

Start Date

12/18/2024

Completion Date

4/30/2027

Summary

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).

Detailed Description

An observational study to investigate the natural history and clinical course of children, adolescents, and young adults with symptoms of gastroparesis (e.g., nausea, vomiting, abdominal pain, bloating, distention) with either delayed or normal gastric emptying. To better understand these disorders, this registry will capture demographic, clinical, physiological, questionnaire, and patient outcome data to characterize the participants and their clinical course.

Eligibility Criteria

Age Range: 8 years to 25 years

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 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 * Gastrointestinal construction confirmed by upper endoscopy (EGD), upper gastrointestinal series (UGI), or abdominal CT * Primary neurological conditions that can cause nausea and vomiting such as increased intracranial pressure, space occupying or inflammatory/infectious legions * 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., 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) * Use of medications that can affect motility during the gastric emptying study * Any other condition, which in the option of the investigator, could explain the symptoms or could interfere with study requirements.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

GastroparesisGastroparesis-like Syndrome

Locations

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Texas Tech University Health Science Center

El Paso, Texas 79905

United States

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas 77030

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States