GpCRC Pediatric Gastroparesis Registry 2 (PGpR2)

March 30, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

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

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).

Study Overview

Status

Recruiting

Conditions

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, 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.

Study Type

Observational

Enrollment (Estimated)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Braden Kuo, MD
        • Sub-Investigator:
          • Claire Zar-Kessler, MD
        • Contact:
        • Contact:
    • Ohio
    • Texas
      • El Paso, Texas, United States, 79905
        • Recruiting
        • Texas Tech University Health Science Center
        • Principal Investigator:
          • Irene Sarosiek
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Texas Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Geoffrey A Preidis, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be 216 participants aged 8-25 years of age with symptoms of Gp located in the United States.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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™
Time Frame: 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.
Baseline, 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of Carnett's sign as assessed by abdominal examination
Time Frame: Baseline

Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.

A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis).

A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain.
Baseline
Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test
Time Frame: Baseline, 48 weeks
Change from baseline to 48 weeks in amount of liquid (mL) consumed during the Water Load Satiety Test (WLST) Lower volumes are signs of impaired accommodation.
Baseline, 48 weeks
Change in Pain Catastrophizing Scale scores (PCS)
Time Frame: Baseline, 48 weeks
The outcome is assessed using change in the total score at 48-weeks minus the baseline score. A negative change indicates reduced pain catastrophizing. PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.
Baseline, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Massachusetts General Hospital
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston Children's Hospital
Nationwide Children's Hospital
Texas Tech University Health Sciences Center, El Paso
Children's Wisconsin

Investigators

  • Principal Investigator: David Shade, JD, Johns Hopkins Bloomberg School of Public Health
  • Study Chair: Geoffrey Preidis, MD, PhD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-DK-PGpR2
  • U01DK112194 (U.S. NIH Grant/Contract)
  • U24DK074008 (U.S. NIH Grant/Contract)
  • U01DK112193 (U.S. NIH Grant/Contract)
  • U01DK074035 (U.S. NIH Grant/Contract)
  • IRB00416909 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The type(s) of supporting information that will be shared include deidentified individual participant data set and data dictionaries.

IPD Sharing Time Frame

Within 1 year of the end of the funding cycle.

IPD Sharing Access Criteria

application

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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