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

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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 (symptoms of gastroparesis but normal gastric emptying).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Texas
Texas Tech University Health Science Center
RECRUITING
El Paso
Baylor College of Medicine/Texas Children's Hospital
RECRUITING
Houston
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Laura Miriel
laura.miriel@jhu.edu
410-955-4165
Backup
Peggy Adamo
madamo1@jhu.edu
410-502-9137
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 216
Treatments
Ages 8-25 with delayed gastric emptying
Participants aged 8-25 with delayed gastric emptying of solids based on gastric emptying scintigraphy
Ages 8-25 with normal gastric emptying
Participants aged 8-25 with normal gastric emptying of solids based on gastric emptying scintigraphy
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Nationwide Children's Hospital, Boston Children's Hospital, Children's Wisconsin, Massachusetts General Hospital, Texas Tech University Health Sciences Center, El Paso, Baylor College of Medicine
Leads: Johns Hopkins Bloomberg School of Public Health

This content was sourced from clinicaltrials.gov