National registry for children and young adults with gastroparesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Pediatric Gastroparesis Registry 2 aims to establish a national prospective registry for children, adolescents, and young adults experiencing gastroparesis and gastroparesis-like syndrome. This observational study will collect data on the natural history and clinical course of participants, focusing on symptoms such as nausea, vomiting, and abdominal pain. By capturing demographic, clinical, physiological, and patient-reported outcome data, the registry seeks to enhance understanding of these gastrointestinal disorders and their impact on young patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Texas Tech University Health Science Center
  El Paso, Texas, United States Recruiting
• Baylor College of Medicine/Texas Children's Hospital
  Houston, Texas, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: David Shade, JD — Johns Hopkins Bloomberg School of Public Health
• Study coordinator: Laura Miriel
• Email: laura.miriel@jhu.edu
• Phone: 410-955-4165

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gastric-focused ultrasound to see if it changes stomach activity and symptoms

  This study tests whether noninvasive stomach-focused ultrasound can alter post-meal stomach electrical activity and symptoms in adults with gastroparesis or delayed gastric emptying, using a sham control in a crossover design.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07851727

• Gastric emptying and feeding tolerance in ICU patients by vasopressor dose

  This study tests whether vasopressor dose affects how well stomach contents empty during tube feeding in critically ill patients.

  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul · NCT07802379

• Virtual poetry workshops to boost well-being for people with digestive symptoms

  This study tests whether participating in online poetry workshops can improve emotional well-being for adults with chronic digestive symptoms and anxiety or depression.

  Recruiting Ohio State University · Columbus, Ohio · NCT07717541

• Risk prediction for gastric retention during sedated gastroscopy

  This study will test a simple grading system and prediction model to see if clinicians can identify which adults are likely to have significant stomach contents before sedated gastroscopy.

  Recruiting at 2 sites Zhejiang University · Hangzhou, Zhejiang and 2 other locations · NCT07104214

• Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients

  This study tests whether using Body Surface Gastric Mapping can help predict which medications will help people with gastroparesis or functional dyspepsia see improvement.

  Recruiting at 2 sites University of Auckland, New Zealand · Philadelphia, Pennsylvania and 2 other locations · NCT06854120

• Using Growth Hormone to Treat Gastroparesis

  This study is testing if Growth Hormone can help people with gastroparesis feel better when other treatments haven't worked.

  Recruiting at 2 sites Early Phase 1 Mayo Clinic · Phoenix, Arizona and 1 other locations · NCT06803589

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.