Status:
RECRUITING
GpCRC Pediatric Gastroparesis Registry 2
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Texas Tech University Health Sciences Center, El Paso
Conditions:
Gastroparesis
Gastroparesis-like Syndrome
Eligibility:
All Genders
8-25 years
Brief 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 (symp...
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, bloatin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05981300
Start Date
December 18 2024
End Date
June 30 2027
Last Update
July 9 2025
Active Locations (6)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Texas Tech University Health Science Center
El Paso, Texas, United States, 79905