Overview
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
Inclusion Criteria:
- Male or female age 8-25 years
- Confirmed diagnosis of a functional gastrointestinal and/or motility disorder by Rome IV criteria
- Body mass index of < 35
- Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test and must use an acceptable method of contraception for the duration of the study
- Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria:
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
- Pregnant women
- Those with any condition, where fasting is not recommended by a physician
- Allergies to foods that may be included in the standardized meal
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures