GpCRC Pediatric Gastroparesis Registry 2 (PGpR2)

Johns Hopkins Bloomberg School of Public Health

Status

Enrolling

Conditions

Gastroparesis-like Syndrome

Gastroparesis

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT05981300

IRB00416909 (Other Identifier)

U24DK074008 (U.S. NIH Grant/Contract)

U01DK112194 (U.S. NIH Grant/Contract)

15-DK-PGpR2

U01DK074035 (U.S. NIH Grant/Contract)

U01DK112193 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

216 estimated patients

Sex

All

Ages

8 to 25 years old

Volunteers

No Healthy Volunteers

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.