Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
Children's Hospital of Philadelphia
Summary
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.
Description
This is an prospective, multi-cohort study that will focus on adaptation and optimization of a novel non-invasive device called 'Body Surface Gastric Mapping (BSGM)' for use in children including defining and optimizing normal ranges in healthy children, defining abnormal patterns in children with GI symptoms, comparing BSGM patterns with currently used diagnostic tests, and evaluating the mechanisms behind current therapeutic interventions using BSGM patterns as biomarkers.
Eligibility
- Age range
- 8–25 years
- Sex
- All
- Healthy volunteers
- Yes
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 (informe…
Interventions
- DeviceBody surface gastric mapping device
A medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
Locations (5)
- Alliant International UniversitySan Diego, California
- Children's Mercy HospitalKansas City, Missouri
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Nationwide Children's HospitalColumbus, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania