Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Body surface gastric mapping device
- Conditions
- Gastrointestinal Motility Disorders in Children
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 685
- Locations
- 5
- Primary Endpoint
- BSGM pediatric reference ranges in healthy controls.
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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:
- •Colonic Manometry
- •Pyloric Botox
- •Pyloric Dilation
- •Gastric Scintigraphy
- •Those with a body mass index of \<
- •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. 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.
- •Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
- •Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
- •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.
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Inclusion Criteria for Controls
- •Males or females age 8 to 25 years.
Arms & Interventions
Children with functional GI disorders
Intervention: Body surface gastric mapping device
Healthy controls
Intervention: Body surface gastric mapping device
Outcomes
Primary Outcomes
BSGM pediatric reference ranges in healthy controls.
Time Frame: 30 minutes before the meal and 4 hours after having meal.
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.
Secondary Outcomes
- Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).(30 minutes before the meal and 4 hours after having meal.)
- Abnormal BSGM patterns in participants with functional GI disorders.(30 minutes before the meal and 4 hours after having meal.)
- Nausea Severity(30 minutes before the meal and 4 hours after having meal.)
- Quality of life - Pediatric Quality of Life Modules(30 minutes before the meal and 4 hours after having meal.)
- Compare pediatric BSGM patterns with gastric scintigraphy, a reference diagnostic test.(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after percutaneous electrical nerve field stimulation (PENFS).(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after pyloric Botulinum toxin (Botox) injection.(30 minutes before the meal and 4 hours after having meal.)
- Correlation Model Parameters(1 hour before the meal and 4 hours after having meal.)
- Quality of Life - PROMIS-25 Instrument(30 minutes before the meal and 4 hours after having meal.)
- Compare Colonic Motor Patterns(1 hour before the meal and 4 hours after having meal.)
- Abdominal Pain Severity(30 minutes before the meal and 4 hours after having meal.)
- Quality of Life - PAGI-QoL(30 minutes before the meal and 4 hours after having meal.)
- Compare BSGM metrics with the antroduodenal manometry (ADM) metrics.(30 minutes before the meal and 4 hours after having meal.)
- Changes in BSGM patterns after heart rate variability biofeedback (HRVB) sessions.(Baseline visit before HRVB and two weeks after HRVB.])
- Changes in BSGM patterns after placement of a gastric electrical stimulator (GES).(30 minutes before the meal and 4 hours after having meal.)