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New study tracks stomach paralysis in kids to uncover clues

NCT ID NCT05981300

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

8 to 25 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Baylor College of Medicine/Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Texas Tech University Health Science Center

    RECRUITING

    El Paso, Texas, 79905, United States

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