National registry for children and young adults with gastroparesis
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
This study is creating a national registry to track the symptoms and experiences of children and young adults with gastroparesis to better understand the condition and how it affects their lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 216 (estimated) |
| Ages | 8 Years to 25 Years |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT05981300 on ClinicalTrials.gov |
What this trial studies
The Pediatric Gastroparesis Registry 2 aims to establish a national prospective registry for children, adolescents, and young adults experiencing gastroparesis and gastroparesis-like syndrome. This observational study will collect data on the natural history and clinical course of participants, focusing on symptoms such as nausea, vomiting, and abdominal pain. By capturing demographic, clinical, physiological, and patient-reported outcome data, the registry seeks to enhance understanding of these gastrointestinal disorders and their impact on young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and young adults aged 8 to 25 who have experienced symptoms of gastroparesis for at least 12 weeks.
Not a fit: Patients who do not exhibit symptoms of gastroparesis or who are outside the age range of 8 to 25 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could lead to improved diagnosis and management strategies for pediatric patients with gastroparesis.
How similar studies have performed: Other studies have successfully utilized registry approaches to better understand gastrointestinal disorders, indicating potential for this study's success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 5 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Texas Tech University Health Science Center — El Paso, Texas, United States (Recruiting)
- Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: David Shade, JD — Johns Hopkins Bloomberg School of Public Health
- Study coordinator: Laura Miriel
- Email: laura.miriel@jhu.edu
- Phone: 410-955-4165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.