About this trial

The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.

Eligibility criteria

Qualifiers

Males or females age 8 to 25 years.

Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.

HRVB

PENFS

Disqualifiers

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.)

Pregnant women.

Those with any condition, where fasting is not recommended by a physician.

Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.

Trial design

Treatments tested in this trial

  • Body surface gastric mapping device

Treatment groups

685 Participants
are divided into 2 treatment groups

Locations

5
Alliant International University92131, San DiegoCalifornia, United States
Children's Mercy Hospital64108, Kansas CityMissouri, United States
Cincinnati Children's Hospital Medical Center45229, CincinnatiOhio, United States
Nationwide Children's Hospital43205, ColumbusOhio, United States

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

University of Auckland, New Zealand

Collaborator