New stomach mapping device could unlock mysteries of Kids' tummy troubles
NCT ID NCT05880199
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 685 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Jun 2028
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
Children and adolescents with functional GI and/or motility disorders, and healthy controls.
- Ages
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8 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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 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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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Alliant International University
RECRUITINGSan Diego, California, 92131, United States
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Children's Mercy Hospital
RECRUITINGKansas City, Missouri, 64108, United States
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Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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