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New stomach mapping device could unlock mysteries of Kids' tummy troubles

NCT ID NCT05880199

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observational study aims to understand stomach electrical activity in children aged 8-25 with digestive issues like slow stomach emptying or chronic pain. Researchers will use a non-invasive device (BSGM) to record stomach signals for up to 4 hours and compare them to healthy children. The goal is to identify abnormal patterns linked to specific symptoms, which could improve diagnosis in the future.

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 685 people

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

Started

Oct 2021

Expected to finish

Jun 2028

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

Children and adolescents with functional GI and/or motility disorders, and healthy controls.

Ages

8 to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 for Cases 1. Males or females age 8 to 25 years. 2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test. 3. Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers: 1. HRVB 2. PENFS 3. ADM 4. Colonic Manometry 5. Pyloric Botox 6. Pyloric Dilation 7. Gastric Scintigraphy 8. GES 9. gammaCore 4. Those with a body mass index of \< 35. 5. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Cases 1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.) 2. Pregnant women. 3. Those with any condition, where fasting is not recommended by a physician. 4. Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal. 5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration. 6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires. 7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion. 8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Inclusion Criteria for Controls 1. Males or females age 8 to 25 years. 2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test. 3. Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future. 4. Those with a body mass index of \< 35. 5. Individuals may include siblings of those with FGIDs. 6. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Controls 1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. 2. Pregnant women. 3. Those with any condition, where fasting is not recommended by a physician. 4. Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal. 5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration. 6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires. 7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion. 8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Alliant International University

    RECRUITING

    San Diego, California, 92131, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

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