NCT05981300 · Johns Hopkins Bloomberg School of Public Health
GpCRC Pediatric Gastroparesis Registry 2
(PGpR2)
What this study is about
The objective of the Pediatric Gastroparesis Registry 2 is to create a national forward-looking registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like syndrome (symptoms of gastroparesis but normal gastric emptying).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
- Boston, Massachusetts
- Columbus, Ohio
- El Paso, Texas
- Houston, Texas
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations