Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT05981300

Conditions

Gastroparesis

Gastroparesis-like Syndrome

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05981300

Start date

Dec 18, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Not accepted

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 Design

Enrollment

216 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Laura Miriel

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

Peggy Adamo

410-502-9137madamo1@jhu.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Nir Bar, MD

617-609-9393nbar@mgh.harvard.edu

Anna Borodianski

(617) 724-0480aborodianski@mgh.harvard.edu

Principal Investigator:

Braden Kuo, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Samuel Nurko, MD

617-355-6055Samuel.Nurko@childrens.harvard.edu

Elise Delaney

617-355-6055Elise.Delaney@childrens.harvard.edu

Principal Investigator:

Samuel Nurko, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Amina Usman, MD

Amina.Usman@nationwidechildrens.org

Peter Lu

Peter.Lu@nationwidechildrens.org

Principal Investigator:

Peter Lu, MD

Texas Tech University Health Science Center

Recruiting

El Paso, Texas, United States, 79905

Contacts

Denease Francis, MD

915-215-5042denease.francis@ttuhsc.edu

Denise Vasquez

915-214-4388denise.vasquez@ttuhsc.edu

Principal Investigator:

Irene Sarosiek

Baylor College of Medicine/Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Geoffrey A Preidis, MD, PhD

832-822-3617geoffrey.preidis@bcm.edu

Heather Charron

713-798-0381charron@bcm.edu

Principal Investigator:

Geoffrey A Preidis, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Katja Karrento, MD

414-266-3690kkarrento@mcw.edu

Taryn Steberl

(262) 336-5233tsteberl@mcw.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Functional Disorder of Gastrointestinal Tract
  • Gastro-Intestinal Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-04-03.