GpCRC Pediatric Gastroparesis Registry 2

NCT05981300 | Recruiting DMC

• 6 other identifiers: 15-DK-PGpR2U01DK112194U01DK112193U01DK074035U24DK074008IRB00416909
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Gastroparesis; Gastroparesis-like Syndrome

Keywords

Functional Disorder of Gastrointestinal Tract; Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

• 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™

  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 Outcomes (3)

• Presence or absence of Carnett's sign as assessed by abdominal examination

  Baseline

• Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test

  Baseline, 48 weeks

• Change in Pain Catastrophizing Scale scores (PCS)

  Baseline, 48 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Texas Tech University Health Sciences Center, El Paso: collaborator
• Baylor College of Medicine: collaborator
• Massachusetts General Hospital: collaborator
• Children's Wisconsin: collaborator
• Boston Children's Hospital: collaborator
• Nationwide Children's Hospital: collaborator

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

RECRUITING

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum.

MeSH Terms

Conditions

Gastroparesis; Gastrointestinal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Geoffrey Preidis, MD, PhD

  Baylor College of Medicine

  STUDY CHAIR

• David Shade, JD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Miriel

CONTACT

410-955-4165; laura.miriel@jhu.edu

Peggy Adamo

CONTACT

410-502-9137; madamo1@jhu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: December 18, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of the end of the funding cycle.
• Access Criteria: application

Locations

US (6)