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.
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
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.
Children and adolescents with functional GI and/or motility disorders, and healthy controls.
Cohort
Prospective
Body surface gastric mapping device
DeviceA medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
BSGM pediatric reference ranges in healthy controls.
Healthy children will be recruited to provide BSGM reference range data. Control data will be used to compute normative data ranges for each key BSGM metric before and after the test meal: slow wave direction, pattern, velocity, frequency, and amplitude. For reference ranges: * BMI-adjusted amplitude: normal reference range at 5-95% CI * Rhythm-Index: normal reference range with cutoff \<5% CI * Frequency: 5-95% CI * Fed: fasted amplitude ratio: \<5% CI * Slow wave pattern: descriptive These outcomes will be measured via the myoelectric activity picked up by the BSGM device.
Abnormal BSGM patterns in participants with functional GI disorders.
Abnormal BSGM patterns in participants with GI disorders will be measured by correlating physiological outcomes with symptoms. This will be done by correlating the spectral and spatial data of the stomach collected by the BSGM array with patient symptoms that are entered directly into a symptom-logging app throughout the duration of the BSGM study visit.
Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).
The FDI is a validated tool that uses child and parent-reported measure of limitations in children's physical and psychosocial functioning due to their physical health. The instrument consists of 15-items concerning activity limitations during the past two weeks. The four levels of disability are scored as followed: No/Minimal (0-12), Mild (13-20), Moderate (21-29) and Severe (≥30).
Nausea Severity
Nausea severity will be assessed by the subject's self-report responses on the Nausea severity scale (NSS) about chronic nausea. The NSS assesses four characteristics of nausea during the past two weeks: number of days with nausea, number of nausea episodes per day, typical nausea duration, and typical intensity of nausea episodes. A total score ranging from 0 - 4 represents the severity of nausea.
Abdominal Pain Severity
The correlation of abdominal pain to functional disability will be measured and quantified by the subject's response to the Abdominal Pain Index (API). The API assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. A total score ranging from 0 (no pain) to - 4 (severe pain) represents the severity of abdominal pain.
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Children's Hospital of Philadelphia
Lead sponsor
University of Auckland, New Zealand
Collaborator
