New study tracks stomach paralysis in kids to uncover clues
NCT ID NCT05981300
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is creating a national registry of 216 children, teens, and young adults (ages 8-25) with gastroparesis or similar symptoms. Researchers will track how symptoms like nausea and stomach pain change over 48 weeks using questionnaires and stomach-emptying tests. The goal is to better understand the condition, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will be 216 participants aged 8-25 years of age with symptoms of Gp located in the United States.
- Ages
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8 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor College of Medicine/Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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Texas Tech University Health Science Center
RECRUITINGEl Paso, Texas, 79905, United States
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