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Pediatric Gastroparesis Registry 2

This study is creating a national registry to better understand gastroparesis and gastroparesis-like syndrome in children, teenagers, and young adults. Gastroparesis is a condition where your stomach empties food too slowly, and gastroparesis-like syndrome has similar symptoms but normal stomach emptying. The study is collecting information on participants' health and symptoms to learn more about how these conditions develop and change over time. To join, you must be between 8 and 25 years old and have had gastroparesis symptoms (like nausea or vomiting) for at least 12 weeks. The main goal is to track changes in the severity of your gastrointestinal symptoms using a special questionnaire over 48 weeks.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to enroll 216 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 48 weeks to track changes in their symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05981300

GpCRC Pediatric Gastroparesis Registry 2

Recruiting
Not specifiedAges 8–25Observational
Johns Hopkins Bloomberg School of Public Health
~216 participants
Updated 2026-04-03 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales™
Measured over Baseline, 48 weeks

Conditions

Gastroparesis
Gastroparesis-like Syndrome

Explore related trials

Digestive System DisorderFunctional disorder of gastrointestinal tractGastroparesis

Where it's being run

6 sites across 4 states
Massachusetts2
Texas2
Ohio1
Wisconsin1

Study leadership

  • Geoffrey Preidis, MD, PhD · STUDY_CHAIR · Baylor College of Medicine
  • David Shade, JD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health

Who to contact

Laura Miriel
[email protected]
410-955-4165
Email the study team

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Do you actually qualify for this trial?

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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:
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.

What this trial measures

  • Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales™Baseline, 48 weeks

    The PedsQL™ GI Symptoms Scales questionnaire has 65 response items covering 10 dimensions, with each item offered as a better-to-worse 5-point Likert scale choice: 0=never, 1=almost never, 2=sometimes, 3=often, 4=almost always. The item responses are transformed to a worse-to-better order and rescaled to 0-100: 0=almost always, 25= often, 50=sometimes, 75=almost never, 100= never, with higher scores indicating better health-related quality of life (HRQOL) and fewer problems or symptoms.he per-participant PedsQL™ GI Symptoms Scales total score is the sum of the 65 transformed and rescaled item responses. The primary outcome measure is the arithmetic mean of the 65 transformed item responses and is repeated at baseline and 48 weeks for each participant.