GpCRC Pediatric Gastroparesis Registry 2

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).

Conditions

Gastroparesis, Gastroparesis-like Syndrome

Study Overview

Study Details

Study overview

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).

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

GpCRC Pediatric Gastroparesis Registry 2

Condition
Gastroparesis
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

El Paso

Texas Tech University Health Science Center, El Paso, Texas, United States, 79905

Houston

Baylor College of Medicine/Texas Children's Hospital, Houston, Texas, United States, 77030

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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
  • * 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.

Ages Eligible for Study

8 Years to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins Bloomberg School of Public Health,

Robert J Shulman, MD, STUDY_CHAIR, Baylor College of Medicine

David Shade, JD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

2027-06-30